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Group Trials Register (group + trials_register)
Selected AbstractsReplacement versus repair of defective restorations in adults: resin compositeAUSTRALIAN DENTAL JOURNAL, Issue 3 2010MO Sharif Background:, Composite filling materials have been increasingly used for the restoration of posterior teeth in recent years as a tooth coloured alternative to amalgam. As with any filling material composites have a finite life-span. Traditionally, replacement was the ideal approach to treat defective composite restorations, however, repairing composites offers an alternative more conservative approach where restorations are partly still serviceable. Repairing the restoration has the potential of taking less time and may sometimes be performed without the use of local anaesthesia hence it may be less distressing for a patient when compared with replacement. Objectives:, To evaluate the effectiveness of replacement (with resin composite) versus repair (with resin composite) in the management of defective resin composite dental restorations in permanent molar and premolar teeth. Search strategy:, For the identification of studies relevant to this review we searched the Cochrane Oral Health Group Trials Register (to 23rd September 2009); CENTRAL (The Cochrane Library 2009, Issue 4); MEDLINE (1950 to 23rd September 2009); EMBASE (1980 to 23rd September 2009); ISI Web of Science (SCIE, SSCI) (1981 to 22nd December 2009); ISI Web of Science Conference Proceedings (1990 to 22nd December 2009); BIOSIS (1985 to 22nd December 2009); and OpenSIGLE (1980 to 2005). Researchers, experts and organizations known to be involved in this field were contacted in order to trace unpublished or ongoing studies. There were no language limitations. Selection criteria:, Trials were selected if they met the following criteria: randomized or quasi-randomized controlled trial, involving replacement and repair of resin composite restorations. Data collection and analysis:, Two review authors independently assessed titles and abstracts for each article identified by the searches in order to decide whether the article was likely to be relevant. Full papers were obtained for relevant articles and both review authors studied these. The Cochrane Collaboration statistical guidelines were to be followed for data synthesis. Main results:, The search strategy retrieved 279 potentially eligible studies, after de-duplication and examination of the titles and abstracts all but four studies were deemed irrelevant. After further analysis of the full texts of the four studies identified, none of the retrieved studies met the inclusion criteria and all were excluded from this review. Authors' conclusions:, There are no published randomised controlled clinical trials relevant to this review question. There is therefore a need for methodologically sound randomised controlled clinical trials that are reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement (http://www.consort-statement.org/). Further research also needs to explore qualitatively the views of patients on repairing versus replacement and investigate themes around pain, anxiety and distress, time and costs. [source] Enamel matrix derivative (Emdogain®) for periodontal tissue regeneration in intrabony defectsAUSTRALIAN DENTAL JOURNAL, Issue 1 2010M Esposito Background:, Periodontitis is a chronic infective disease of the gums caused by bacteria present in dental plaque. This condition induces the breakdown of the tooth supporting apparatus until teeth are lost. Surgery may be indicated to arrest disease progression and regenerate lost tissues. Several surgical techniques have been developed to regenerate periodontal tissues including guided tissue regeneration (GTR), bone grafting (BG) and the use of enamel matrix derivative (EMD). EMD is an extract of enamel matrix and contains amelogenins of various molecular weights. Amelogenins are involved in the formation of enamel and periodontal attachment formation during tooth development. Objectives:, To test whether EMD is effective, and to compare EMD versus GTR, and various BG procedures for the treatment of intrabony defects. Search strategy:, We searched the Cochrane Oral Health Group Trials Register, CENTRAL, MEDLINE and EMBASE. Several journals were handsearched. No language restrictions were applied. Authors of randomized controlled trials (RCTs) identified, personal contacts and the manufacturer were contacted to identify unpublished trials. Most recent search: February 2009. Selection criteria:, RCTs on patients affected by periodontitis having intrabony defects of at least 3 mm treated with EMD compared with open flap debridement, GTR and various BG procedures with at least 1 year follow-up. The outcome measures considered were: tooth loss, changes in probing attachment levels (PAL), pocket depths (PPD), gingival recessions (REC), bone levels from the bottom of the defects on intraoral radiographs, aesthetics and adverse events. The following time-points were to be evaluated: 1, 5 and 10 years. Data collection and analysis:, Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted in duplicate and independently by two authors. Results were expressed as random-effects models using mean differences for continuous outcomes and risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CI). It was decided not to investigate heterogeneity, but a sensitivity analysis for the risk of bias of the trials was performed. Main results:, Thirteen trials were included out of 35 potentially eligible trials. No included trial presented data after 5 years of follow-up, therefore all data refer to the 1-year time point. A meta-analysis including nine trials showed that EMD treated sites displayed statistically significant PAL improvements (mean difference 1.1 mm, 95% CI 0.61 to 1.55) and PPD reduction (0.9 mm, 95% CI 0.44 to 1.31) when compared to placebo or control treated sites, though a high degree of heterogeneity was found. Significantly more sites had <2 mm PAL gain in the control group, with RR 0.53 (95% CI 0.34 to 0.82). Approximately nine patients needed to be treated (NNT) to have one patient gaining 2 mm or more PAL over the control group, based on a prevalence in the control group of 25%. No differences in tooth loss or aesthetic appearance as judged by the patients were observed. When evaluating only trials at a low risk of bias in a sensitivity analysis (four trials), the effect size for PAL was 0.62 mm (95% CI 0.28 to 0.96), which was less than 1.1 mm for the overall result. Comparing EMD with GTR (five trials), GTR showed statistically significant more postoperative complications (three trials, RR 0.12, 95% CI 0.02 to 0.85) and more REC (0.4 mm 95% CI 0.15 to 0.66). The only trial comparing EMD with a bioactive ceramic filler found statistically significant more REC (-1.60 mm, 95% CI ,2.74 to ,0.46) at the EMG treated sites. Authors' conclusions:, One year after its application, EMD significantly improved PAL levels (1.1 mm) and PPD reduction (0.9 mm) when compared to a placebo or control, however, the high degree of heterogeneity observed among trials suggests that results have to be interpreted with great caution. In addition, a sensitivity analysis indicated that the overall treatment effect might be overestimated. The actual clinical advantages of using EMD are unknown. With the exception of significantly more postoperative complications in the GTR group, there was no evidence of clinically important differences between GTR and EMD. Bone substitutes may be associated with less REC than EMD. Plain language summary:, Enamel matrix derivative (Emdogain®) for periodontal tissue regeneration in intrabony defects. Emdogain might have some advantages over other methods of regenerating the tissue supporting teeth lost by gum disease, such as less postoperative complications, but has not been shown to save more compromised teeth or that patients noticed any aesthetic improvement 1 year after its application. Bacteria in plaque can cause gum disease (periodontitis) that breaks down tissue supporting teeth. Surgical cleaning tries to stop the disease to save loose teeth. Bone grafting, guided tissue regeneration and enamel matrix derivatives (such as Emdogain) aim to regenerate support tissues. Emdogain contains proteins (derived from developing pig teeth) believed to regenerate tooth attachment. The review found that adjunctive application of Emdogain regenerates about 1 mm more tissue than surgical cleaning alone, although it is unclear to which extent such improvement is noticeable since patients did not find any difference in the aesthetic results. Emdogain showed similar clinical results to guided tissue regeneration, but is simpler to use and determines less complications. Bone substitutes may induce less gum retraction than Emdogain. No serious adverse reactions to Emdogain were reported in trials. [source] Antenatal Perineal Massage for Reducing Perineal TraumaBIRTH, Issue 2 2006M.M. Beckmann Background:, Perineal trauma following vaginal birth can be associated with significant short- and long-term morbidity. Antenatal perineal massage has been proposed as one method of decreasing the incidence of perineal trauma. Objectives:, To assess the effect of antenatal perineal massage on the incidence of perineal trauma at birth and subsequent morbidity. Search strategy:, We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 January 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2005), PubMed (1966 to January 2005), EMBASE (1980 to January 2005) and reference lists of relevant articles. Selection criteria:, Randomised and quasi-randomised controlled trials evaluating any described method of antenatal perineal massage undertaken for at least the last four weeks of pregnancy. Data collection and analysis:, Both review authors independently applied the selection criteria, extracted data from the included studies and assessed study quality. We contacted study authors for additional information. Main results:, Three trials (2434 women) comparing digital perineal massage with control were included. All were of good quality. Antenatal perineal massage was associated with an overall reduction in the incidence of trauma requiring suturing (three trials, 2417 women, relative risk (RR) 0.91 (95% confidence interval (CI) 0.86 to 0.96), number needed to treat (NNT) 16 (10 to 39)). This reduction was statistically significant for women without previous vaginal birth only (three trials, 1925 women, RR 0.90 (95% CI 0.84 to 0.96), NNT 14 (9 to 35)). Women who practised perineal massage were less likely to have an episiotomy (three trials, 2417 women, RR 0.85 (95% CI 0.75 to 0.97), NNT 23 (13 to 111)). Again this reduction was statistically significant for women without previous vaginal birth only (three trials, 1925 women, RR 0.85 (95% CI 0.74 to 0.97), NNT 20 (11 to 110)). No differences were seen in the incidence of 1st or 2nd degree perineal tears or 3rd/4th degree perineal trauma. Only women who have previously birthed vaginally reported a statistically significant reduction in the incidence of pain at three months postpartum (one trial, 376 women, RR 0.68 (95% CI 0.50 to 0.91) NNT 13 (7 to 60)). No significant differences were observed in the incidence of instrumental deliveries, sexual satisfaction, or incontinence of urine, faeces or flatus for any women who practised perineal massage compared with those who did not massage. Authors' conclusions:, Antenatal perineal massage reduces the likelihood of perineal trauma (mainly episiotomies) and the reporting of ongoing perineal pain and is generally well accepted by women. As such, women should be made aware of the likely benefit of perineal massage and provided with information on how to massage. *** The preceding report is an Abstract of a regularly updated, systematic review prepared and maintained by the Cochrane Collaboration. The full text of the review is available in The Cochrane Library (ISSN 1464,780X). The Cochrane Database of Systematic Reviews 2006 Issue 1. Copyright © 2006 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [source] Epidural versus Non-Epidural or No Analgesia in LabourBIRTH, Issue 1 2006Article first published online: 28 JUN 200 A substantive amendment to this systematic review was last made on 16 August 2005. Cochrane reviews are regularly checked and updated if necessary. Abstract Background:, Epidural analgesia is a central nerve block technique achieved by injection of a local anaesthetic close to the nerves that transmit pain and is widely used as a form of pain relief in labour. However, there are concerns regarding unintended adverse effects on the mother and infant. Objectives:, To assess the effects of all modalities of epidural analgesia (including combined-spinal-epidural) on the mother and the baby, when compared with non-epidural or no pain relief during labour. Search strategy:, We searched the Cochrane Pregnancy and Childbirth Group Trials Register (June 2005). Selection criteria:, Randomised controlled trials comparing all modalities of epidural with any form of pain relief not involving regional blockade, or no pain relief in labour. Data collection and analysis Two of the review authors independently assessed trials for eligibility, methodological quality and extracted all data. Data were entered into RevMan and double checked. Primary analysis was by intention-to-treat; sensitivity analyses excluded trials with >30% of women receiving un-allocated treatment. Main results:, Twenty-one studies involving 6664 women were included, all but one study compared epidural analgesia with opiates. For technical reasons, data on women's perception of pain relief in labour could only be included from one study, which found epidural analgesia to offer better pain relief than non-epidural analgesia (weighted mean difference (WMD),2.60, 95% confidence interval (CI),3.82 to ,1.38, 1 trial, 105 women). However, epidural analgesia was associated with an increased risk of instrumental vaginal birth (relative risk (RR) 1.38, 95% CI 1.24 to 1.53, 17 trials, 6162 women). There was no evidence of a significant difference in the risk of caesarean delivery (RR 1.07, 95% CI 0.93 to 1.23, 20 trials, 6534 women), long-term backache (RR 1.00, 95% CI 0.89 to 1.12, 2 trials, 814 women), low neonatal Apgar scores at 5 minutes (RR 0.70, 95% CI 0.44 to 1.10, 14 trials, 5363 women), and maternal satisfaction with pain relief (RR 1.18 95% CI 0.92 to 1.50, 5 trials, 1940 women). No studies reported on rare but potentially serious adverse effects of epidural analgesia. Authors' conclusions:, Epidural analgesia appears to be effective in reducing pain during labour. However, women who use this form of pain relief are at increased risk of having an instrumental delivery. Epidural analgesia had no statistically significant impact on the risk of caesarean section, maternal satisfaction with pain relief and long-term backache and did not appear to have an immediate effect on neonatal status as determined by Apgar scores. Further research may be helpful to evaluate rare but potentially severe adverse effects of epidural analgesia on women in labour and long-term neonatal outcomes. Citation:, Anim-Somuah M, Smyth R, Howell C. Epidural versus non-epidural or no analgesia in labour. The Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD000331.pub2. DOI: 10.1002/14651858.CD000331.pub2. *** The preceding report is an abstract of a regularly updated, systematic review prepared and maintained by the Cochrane Collaboration. The full text of the review is available in The Cochrane Library (ISSN 1465,1858). Abstracts of Cochrane reviews are compiled and produced by Update Software Ltd on behalf of the publisher, John Wiley & Sons Ltd. [source] Continuous Support for Women During ChildbirthBIRTH, Issue 1 2005E.D. Hodnett ABSTRACT Background:, Historically, women have been attended and supported by other women during labour. However, in recent decades in hospitals worldwide, continuous support during labour has become the exception rather than the routine. Concerns about the consequent dehumanization of women's birth experiences have led to calls for a return to continuous support by women for women during labour. Objectives:, Primary: to assess the effects, on mothers and their babies, of continuous, one-to-one intrapartum support compared with usual care. Secondary: to determine whether the effects of continuous support are influenced by: (1) routine practices and policies in the birth environment that may affect a woman's autonomy, freedom of movement, and ability to cope with labour; (2) whether the caregiver is a member of the staff of the institution; and (3) whether the continuous support begins early or later in labour. Search strategy:, We searched the Cochrane Pregnancy and Childbirth Group trials register (30 January 2003) and the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2003). Selection criteria:, All published and unpublished randomized controlled trials comparing continuous support during labour with usual care. Data collection and analysis:, Standard methods of the Cochrane Collaboration Pregnancy and Childbirth Group were used. All authors participated in evaluation of methodological quality. Data extraction was undertaken independently by one author and a research assistant. Additional information was sought from the trial authors. Results are presented using relative risk for categorical data and weighted mean difference for continuous data. Main results:, Fifteen trials involving 12,791 women are included. Primary comparison: Women who had continuous intrapartum support were less likely to have intrapartum analgesia, operative birth, or to report dissatisfaction with their childbirth experiences. Subgroup analyses: In general, continuous intrapartum support was associated with greater benefits when the provider was not a member of the hospital staff, when it began early in labour, and in settings in which epidural analgesia was not routinely available. Reviewers' conclusions:, All women should have support throughout labour and birth. Citation:, Hodnett ED, Gates S, Hofmeyr G J, Sakala C. Continuous support for women during childbirth (Cochrane Review). In: The Cochrane Library, Issue 3, 2004. Chichester, UK: John Wiley & Sons, Ltd. ,,,The preceding report is an abstract of a regularly updated, systematic review prepared and maintained by the Cochrane Collaboration. The full text of the review is available in The Cochrane Library (ISSN 1464-780X). The Cochrane Library is designed and produced by Update Software Ltd, and published by John Wiley & Sons, Ltd. [source] Continuity of Caregivers for Care During Pregnancy and ChildbirthBIRTH, Issue 3 2000E.D. Hodnett A substantive amendment to this systematic review was last made on 17 May 1999. Cochrane reviews are regularly checked and updated if necessary. ABSTRACT Background: Social support may include advice or information, tangible assistance, and emotional support. Objectives: The objective of this review was to assess the effects of continuous support during labour (provided by health care workers or lay people) on mothers and babies. Search strategy: I searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register. Date of last search: April 1999. Selection criteria: Randomised trials comparing continuous support during labour with usual care. Data collection and analysis: Trial quality was assessed. Study authors were contacted for additional information. Main results: Fourteen trials, involving more than 5000 women, are included in the Review. The continuous presence of a support person reduced the likelihood of medication for pain relief, operative vaginal delivery, Caesarean delivery, and a 5-minute Apgar score less than 7. Continuous support was also associated with a slight reduction in the length of labour. Six trials evaluated the effects of support on mothers' views of their childbirth experiences; while the trials used different measures (overall satisfaction, failure to cope well during labour, finding labour to be worse than expected, and level of personal control during childbirth), in each trial the results favoured the group who had received continuous support. Reviewers' conclusions: Continuous support during labour from caregivers (nurses, midwives, or lay people) appears to have a number of benefits for mothers and their babies and there do not appear to be any harmful effects. Citation: Hodnett ED. Caregiver support for women during childbirth (Cochrane Review). In: The Cochrane Library, Issue 1, 2000. Oxford: Update Software. [source] Continuity of Caregivers for Care During Pregnancy and ChildbirthBIRTH, Issue 3 2000E.D. Hodnett A substantive amendment to this systematic review was last made on 04 March 1998. Cochrane reviews are regularly checked and updated if necessary. ABSTRACT Background: Care is often provided by multiple caregivers, many of whom work only in the antenatal clinic, labour ward, or postnatal unit. However, continuity of care is provided by the same caregiver or a small group from pregnancy through the postnatal period. Objectives: The objective of this review was to assess continuity of care during pregnancy and childbirth and the puerperium with usual care by multiple caregivers. Search strategy: The Cochrane Pregnancy and Childbirth Group trials register was searched. Selection criteria: Controlled trials comparing continuity of care with usual care during pregnancy, childbirth and the postnatal period. Data collection and analysis: Trial quality was assessed. Study authors were contacted for additional information. Main results: Two studies involving 1815 women were included. Both trials compared continuity of care by midwives with non-continuity of care by a combination of physicians and midwives. The trials were of good quality. Compared to usual care, women who had continuity of care from a team of midwives were less likely to be admitted to hospital antenatally (odds ratio 0.79, 95% confidence interval 0.64,0.97) and more likely to attend antenatal education programs (odds ratio 0.58, 95% confidence interval 0.41,0.81). They were also less likely to have drugs for pain relief during labour (odds ratio 0.53, 95% confidence interval 0.44,0.64), and their newborns were less likely to require resuscitation (odds ratio 0.66, 95% confidence interval 0.52,0.83). No differences were detected in Apgar scores, low birthweight, and stillbirths or neonatal deaths. While they were less likely to have an episiotomy (odds ratio 0.75, 95% confidence interval 0.60,0.94), women receiving continuity of care were more likely to have either a vaginal or perineal tear (odds ratio 1.28, 95% confidence interval 1.05, 1.56). They were more likely to be pleased with their antenatal, intrapartum, and postnatal care. Reviewers' conclusions: Studies of continuity of care show beneficial effects. It is not clear whether these are due to greater continuity of care, or to midwifery care. Citation: Hodnett ED. Continuity of caregivers for care during pregnancy and childbirth (Cochrane Review). In: The Cochrane Library, Issue 2, 2000. Oxford: Update Software. The preceding reports are abstracts of regularly updated, systematic reviews prepared and maintained by the Cochrane Collaboration. The full texts of the reviews are available in The Cochrane Library (ISSN 1464-780X). Seehttp://www.update-software.com/cochrane.htmor contact Update Software,info@update.co.uk, for information on subscribing to The Cochrane Library in your area. Update Software Ltd, Summertown Pavilion, Middle Way, Oxford OX2 7LG, United Kingdom (Tel.: +44 1865 513902; Fax: +44 1865 516918). [source] SELECTED COCHRANE SYSTEMATIC REVIEWS Absorbable Synthetic Versus Catgut Suture Material for Perineal RepairBIRTH, Issue 2 2000C. Kettle A substantive amendment to this systematic review was last made on 19 May 1999. Cochrane reviews are regularly checked and updated if necessary. ABSTRACT Background and objectives: Approximately 70% of women will experience some degree of perineal trauma following vaginal delivery and will require stitches. This may result in perineal pain and superficial dyspareunia. The objective of this review was to assess the effects of absorbable synthetic suture material as compared with catgut on the amount of short- and long-term pain experienced by mothers following perineal repair. Search strategy: We searched the Cochrane Pregnancy and Childbirth Group trials register. Selection criteria: Randomised trials comparing absorbable synthetic (polyglycolic acid and polyglactin) with plain or chromic catgut suture for perineal repair in mothers after vaginal delivery. Data collection and analysis: Trial quality was assessed independently by two reviewers. Data were extracted by one reviewer and checked by the second reviewer. Main results: Eight trials were included. Compared with catgut, the polyglycolic acid and polyglactin groups were associated with less pain in first three days (odds ratio 0.62, 95% confidence interval 0.54,0.71). There was also less need for analgesia (odds ratio 0,63, 95% confidence interval 0.52,0.77) and less suture dehiscence (odds ratio 0.45, 95% confidence interval 0.29,0.70). There was no significant difference in long-term pain (odds ratio 0.81, 95% confidence interval 0.61,1.08). Removal of suture material was significantly more common in the polyglycolic acid and polyglactin groups (odds ratio 2.01, 95% confidence interval 1.56,2.58). There was no difference in the amount of dyspareunia experienced by women. Reviewers' conclusions: Absorbable synthetic suture material (in the form of polyglycolic acid and polyglactin sutures) for perineal repair following childbirth appears to decrease women's experience of short-term pain. The length of time taken for the synthetic material to be absorbed is of concern. A trial addressing the use of polyglactin has recently been completed and this has been included in this updated review. Citation: Kettle C, Johanson RB. Absorbable synthetic versus catgut suture material for perineal repair (Cochrane Review). In: The Cochrane Library, Issue 4, 1999, Oxford: Update Software. ,,, The preceding report is an abstract of regularly updated, systematic reviews prepared and maintained by the Cochrane Collaboration. The full texts of the reviews are available in The Cochrane Library (ISSN 1464-780X). Seehttp://www.update-software.com/cochrane.htmor contact Update Software,info@update.co.uk, for information on subscribing to The Cochrane Library in your area. Update Software Ltd, Summertown Pavilion, Middle Way, Oxford OX2 7LG, United Kingdom (Tel.: +44 1865 513902; Fax: +44 1865 516918). [source] | ||||||||||