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Randomized-controlled Clinical Trial (randomized-controlled + clinical_trial)
Selected AbstractsGuided tissue regeneration combined with a deproteinized bovine bone mineral (Bio-Oss®) in the treatment of intrabony periodontal defects: 6-year results from a randomized-controlled clinical trialJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 2 2010Andreas Stavropoulos Stavropoulos A, Karring T. Guided tissue regeneration combined with a deproteinized bovine bone mineral (Bio-Oss®) in the treatment of intrabony periodontal defects: 6-year results from a randomized-controlled clinical trial. J Clin Periodontol 2010; 37: 200,210. doi: 10.1111/j.1600-051X.2009.01520.x. Abstract Aim: To present the 6-year results of a randomized-controlled clinical trial evaluating guided tissue regeneration (GTR) combined with or without deproteinized bovine bone mineral (DBBM) in intrabony defects. Material & Methods: In each of 45 patients, one defect was treated with GTR combined with DBBM hydrated in saline (DBBM,) or gentamicin sulphate (DBBM+) or with GTR alone. Clinical parameters were recorded pre-surgery, at 1 and 6 years postsurgery. Results: Thirty-six patients/33 teeth were available for the 6-year control. Statistically significant clinical improvements were observed for all treatments. Clinical attachment level (CAL) gain averaged 2.5 mm (DBBM,), 4.1 mm (DBBM+), and 3.0 mm (GTR) at 1 year postsurgery, and remained stable over 5 additional years (2.3, 4.1, and 2.7 mm, respectively). Treatment did not appear to influence residual probing depths (PDs) or CAL gains at 6 years postsurgery, or the extent of PD and CAL change from 1 to 6 years, and did not associate with sites losing CAL during follow-up. No association of grafting with sites showing CAL gain 4 mm at the 1- or 6-year control was observed. Conclusion: The improvements in periodontal conditions obtained after GTR treatment with or without the adjunct use of DBBM can be preserved on a long-term basis. [source] Connective tissue graft plus resin-modified glass ionomer restoration for the treatment of gingival recession associated with non-carious cervical lesion: a randomized-controlled clinical trialJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 9 2009Mauro Pedrine Santamaria Abstract Background: The aim of this clinical study was to evaluate the treatment of gingival recession, associated with non-carious cervical lesions by a connective tissue graft (CTG) alone, or in combination with a resin-modified glass ionomer restoration (CTG+R). Materials and Methods: Forty patients presenting Miller Class I buccal gingival recessions, associated with non-carious cervical lesions, were selected. The defects were randomly assigned to receive either CTG or CTG+R. Bleeding on probing (BOP), probing depth (PD), relative gingival recession (RGR), clinical attachment level (CAL) and cervical lesion height (CLH) coverage were measured at baseline and 45 days, and 2, 3 and 6 months after treatment. Results: Both groups showed statistically significant gains in CAL and soft tissue coverage. The differences between groups were not statistically significant in BOP, PD, RGR and CAL, after 6 months. The percentages of CLH covered were 74.88 ± 8.66% for CTG and 70.76 ± 9.81% for CTG+R (p>0.05). The estimated root coverage was 91.91 ± 17.76% for CTG and 88.64 ± 11.9% for CTG+R (p>0.05). Conclusion: Within the limits of the present study, it can be concluded that both procedures provide comparable soft tissue coverage. The presence of the glass ionomer restoration may not prevent the root coverage achieved by CTG. [source] Comparison of gingival blood flow during healing of simplified papilla preservation and modified Widman flap surgery: a clinical trial using laser Doppler flowmetryJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 10 2007M. Retzepi Abstract Aim: This prospective randomized-controlled clinical trial compared the gingival blood flow responses following simplified papilla preservation (test) versus modified Widman flap (control). Materials and Methods: Twenty contra-lateral upper sites with pocket depth 5 mm after initial treatment in 10 chronic periodontitis patients were randomly assigned to either test or control treatment, using a split-mouth design. Laser Doppler flowmetry recordings were performed pre-operatively, following anaesthesia, immediately post-operatively and on days 1, 2, 3, 4, 7, 15, 30 and 60, at nine selected sites per flap. Results: Significant ischaemia was observed at all sites following anaesthesia and immediately post-operatively. At the mucosal flap basis, a peak hyperaemic response was observed on day 1, which tended to resolve by day 4 at the test sites, but persisted until day 7 at the control sites. The buccal and palatal papillae blood perfusion presented the maximum increase on day 7 in both groups and returned to baseline by day 15. Both surgical modalities yielded significant pocket depth reduction, recession increase and clinical attachment gain. Conclusions: Periodontal access flaps represent an ischaemia,reperfusion flap model. The simplified papilla preservation flap may be associated with faster recovery of the gingival blood flow post-operatively compared with the modified Widman flap. [source] Polyethylene glycol 4000 vs. lactulose for the treatment of neurogenic constipation in myelomeningocele children: a randomized-controlled clinical trialALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 8 2006C. RENDELI Summary Aim, To compare the therapeutic effectiveness and tolerability of low daily doses of polyethylene glycol 4000 vs. lactulose in the treatment of neurogenic constipation in children with myelomeningocele. Methods, Sixty-seven children with chronic neurogenic constipation were randomized allocated to receive either polyethylene glycol 4000 (0.50 g/kg) or lactulose (1.5 g/kg) for 6 months. Patients or their parents reported frequency and modality of evacuation and side effects on a diary card. Primary outcome was bowel frequency ,3/week, and the second one was side effects at the end of treatment. Results, Complete remission of constipation was reported by a significantly (P < 0.01) higher number of patients treated with polyethylene glycol compared with lactulose. At the end of the study, 46% patients of polyethylene glycol group and 22% of the lactulose group were asymptomatic. Compared with lactulose, patients treated with polyethylene glycol reported higher bowel frequency (5.1 vs. 2.9 bowel movements/week, P < 0.01) and reduction of encopresis. Neither lactulose nor polyethylene glycol caused clinically-significant serious side effects and palatability was similar. Conclusions, Polyethylene glycol 4000 compared with lactulose provided a higher success rate, without significant side effects, for the treatment of constipation in myelomeningocele children. [source] Acupuncture and Chinese herbal medicine in the treatment of patients with seasonal allergic rhinitis: a randomized-controlled clinical trialALLERGY, Issue 9 2004B. Brinkhaus Background:, Patients with allergic rhinitis (AR) increasingly use complementary medicine. The aim of this study was to determine whether traditional Chinese therapy is efficacious in patients suffering from seasonal AR. Methods:, Fifty-two patients between the ages of 20 and 58 who had typical symptoms of seasonal AR were assigned randomly and in a blinded fashion to (i) an active treatment group which received a semi-standardized treatment of acupuncture and Chinese herbal medicine, and (ii) a control group which received acupuncture applied to non-acupuncture points in addition to a non-specific Chinese herbal formula. All patients received acupuncture treatment once per week and the respective Chinese herbal formula as a decoction three times daily for a total of 6 weeks. Assessments were performed before, during, and 1 week after treatment. The change in severity of hay fever symptoms was the primary outcome measured on a visual analogue scale (VAS). Results:, Compared with patients in the control group, patients in the active treatment group showed a significant after-treatment improvement on the VAS (P = 0.006) and Rhinitis Quality of Life Questionnaire (P = 0.015). Improvement on the Global Assessment of Change Scale was noted in 85% of active treatment group participants vs 40% in the control group (P = 0.048). No differences between the two groups could be detected with the Allergic Rhinitis Symptom Questionnaire. Both treatments were well-tolerated. Conclusions:, The results of this study suggest that traditional Chinese therapy may be an efficacious and safe treatment option for patients with seasonal AR. [source] Resilient liner vs. clip attachment effect on peri-implant tissues of bar-implant-retained mandibular overdenture: a 1-year clinical and radiographical studyCLINICAL ORAL IMPLANTS RESEARCH, Issue 5 2010Moustafa Abdou Elsyad Abstract Purpose: The aim of this study was to compare between the effects of resilient liner and clip attachments of bar-implant-retained mandibular overdenture on peri-implant tissues. Materials and methods: In a randomized-controlled clinical trial, 30 edentulous male patients (mean age 62.5 years) were equally assigned to two groups. In each patient, two implants were inserted in the canine area of the mandible using a two-stage surgical protocol. After 3 months, the implants were connected with resilient bars. Mandibular overdentures were retained to the bars with either clips (group I) or silicone-resilient liners (group II). Peri-implant tissues were evaluated clinically (with regard to plaque scores, gingival scores and probing depths) and radiographically (with regard to peri-implant vertical and horizontal alveolar bone changes). Evaluations were performed at the time of overdenture insertion (T0), 6 months (T6) and 12 months (T12) after overdenture insertion. Results: After 12 months of using bar-implant-retained mandibular overdenture, the resilient liner attachment had significantly decreased peri-implant plaque score, gingival score, probing depth, vertical and horizontal bone loss when compared with the clip attachment. Conclusion: Within the limitations of this study, and in terms of peri-implant tissue health of bar-implant-retained mandibular overdenture, we recommend resilient liner rather than clip attachment. To cite this article: Elsyad MA, EL Shoukouki AH. Resilient liner vs. clip attachment effect on peri-implant tissues of bar-implant-retained mandibular overdenture: a 1-year clinical and radiographical study. Clin. Oral Impl. Res. 21, 2010; 473,480 doi: 10.1111/j.1600-0501.2009.01879.x [source] A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxillaCLINICAL ORAL IMPLANTS RESEARCH, Issue 1 2010Mariano Sanz Abstract Aim: The primary objective of this study was to determine the association between the size of the void established by using two different implant configurations and the amount of buccal/palatal bone loss that occurred during 16 weeks of healing following their installation into extraction sockets. Material and methods: The clinical trial was designed as a prospective, randomized-controlled parallel-group multicenter study. Adults in need of one or more implants replacing teeth to be removed in the maxilla within the region 15,25 were recruited. Following tooth extraction, the site was randomly allocated to receive either a cylindrical (group A) or a tapered implant (group B). After implant installation, a series of measurements were made to determine the dimension of the ridge and the void between the implant and the extraction socket. These measurements were repeated at the re-entry procedure after 16 weeks. Results: The study demonstrated that the removal of single teeth and the immediate placement of an implant resulted in marked alterations of the dimension of the buccal ridge (43% and 30%) and the horizontal (80,63%) as well as the vertical (69,65%) gap between the implant and the bone walls. Although the dimensional changes were not significantly different between the two-implant configurations, both the horizontal and the vertical gap changes were greater in group A than in group B. Conclusions: Implant placement into extraction sockets will result in significant bone reduction of the alveolar ridge. To cite this article: Sanz M, Cecchinato D, Ferrus J, Pjetursson EB, Lang NP, Jan L. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla. Clin. Oral Impl. Res. 21, 2009; 13,21. [source] A randomized-controlled clinical trial evaluating clinical and radiological outcomes after 3 and 5 years of dental implants placed in bone regenerated by means of GBR techniques with or without the addition of BMP-2CLINICAL ORAL IMPLANTS RESEARCH, Issue 7 2009Ronald E. Jung Abstract Objective: The aim of this randomized-controlled clinical trial was to evaluate the long-term outcome of implants placed in bone augmented with a xenogenic bone substitute material and a collagen membrane with or without the addition of recombinant human bone morphogenetic protein-2 (rhBMP-2). Material and methods: Eleven patients received a total of 34 implants placed into sites exhibiting lateral bone defects. In a split mouth design, the defects were randomly treated with the graft material and the collagen membrane either with (test) or without (control) rhBMP-2. The patients were examined 3 and 5 years after insertion of the prosthetic restoration. Student's paired t -test was performed to detect differences between the two groups. Results: The survival rate at 3 and 5 years was 100% for both groups. The peri-implant soft tissues were stable and healthy without any difference between the two groups. The prosthetic reevaluation demonstrated four loose prosthetic screws during the first 3 years and seven ceramic chippings after 3 and 5 years. The mean distance between the first bone to implant contact to implant abutment junction at 3 years was 1.37 mm (test), 1.22 mm (control), and 1.38 mm (test), and 1.23 mm (control) at 5 years. The difference of <0.2 mm between test and control implants was not statistically significant. The mean change of the marginal bone level between baseline and 5 years ranged from ,0.07 mm (mesial, test), ,0.11 mm (distal, test), ,0.03 mm (mesial, control), to +0.13 mm (distal, control). No statistically significant differences were observed between test and control sites. Conclusion: Implants placed in bone augmented with and without rhBMP-2 revealed excellent clinical and radiological outcomes after 3 and 5 years. [source] Osteotomy and membrane elevation during the maxillary sinus augmentation procedureCLINICAL ORAL IMPLANTS RESEARCH, Issue 5 2008A comparative study: piezoelectric device vs. conventional rotative instruments Abstract Objectives: The aim of the present study was to investigate in a randomized-controlled clinical trial the performance of rotary instruments compared with a piezoelectric device during maxillary sinus floor elevation. Materials and methods: Thirteen patients who required a bilateral maxillary sinus augmentation for implant,prosthetic rehabilitation were included in this study. A within-patient control study was carried out. The osteotomy for sinus access was performed on one side of the maxilla using the piezosurgery (test sites) and on the other side using conventional rotary diamond burs (control sites). The parameters recorded were as follows: bony window length (L), bony window height (H), bone thickness (T) and osteotomy area (A) , calculated by multiplying L and H. In addition, the time necessary for the osteotomy and sinus membrane elevation as well as the number of surgical complications were calculated. Results: The mean length and height of the bone window were similar in both groups. The osteotomy area (A) obtained by multiplying L and H was wider in the control group (151.2 ± 20.4 mm2) compared with the test group (137 ± 24.2 mm2). The time necessary for the osteotomy and the sinus membrane elevation with conventional instruments was 10.2 ± 2.4 min, while with the piezoelectric device it was 11.5 ± 3.8 min. Moreover, membrane perforation occurred in 30% of the maxillary sinuses in the test group and in 23% of the control group. None of the differences observed between the two groups reached a level of significance. Conclusions: Within the limits of the present study, it may be concluded that piezosurgery and conventional instruments did not show any differences in the clinical parameters investigated for the maxillary sinus floor elevation. [source] | ||||||||||