| Objectives: A clinical trial comparing a domestic polylactic acid oral barrier membrane with a resorbable collagen membrane(Bio-Gide)to evaluate the clinical effectiveness of polylactic acid oral barrier membranes in guiding bone regeneration in upper anterior region implants.Methods: Forty-eight subjects with missing teeth in the maxillary anterior region and requiring guided bone regeneration were recruited and randomly divided into two groups of 24 subjects each,the control group and the trial group.In the trial group,a polylactic acid oral barrier was used and in the control group,a Bio-Gide membrane was used,and the bone filling material was Bio-Oss bone powder.Follow-up visits were made at 1 week and 1 month after surgery to observe wound healing,wound dehiscence,infection,etc.At 6 months after surgery,the implant retention rate was evaluated by measuring implant mobility(ISQ)using an implant mobility meter.Cone beam CT(CBCT)was taken immediately after surgery and at 6 months postoperative follow-up to compare the change in mean thickness of the labial alveolar bone between the two groups at 6 months postoperatively;the soft tissue around the implant was recorded and evaluated at 18 months postoperatively,including probing depth,plaque index,and modified bleeding index;patient satisfaction was also evaluated according to the special form for restoration of implant prostheses with tooth loss(OHIP-I),and all results were analysed statistically using SPSS All results were statistically analysed using SPSS 22.0 software and differences were considered statistically significant at P < 0.05.Result:(1)Wound healing: At 1 week and 1 month postoperative follow-up,45 subjects had good wound healing and 3 subjects had membrane exposure,with 8.33% of the test group and 4.17% of the control group having membrane exposure.The difference in wound healing scores between the two groups was not statistically significant(P>0.05).(2)Implant retention rate: 48 implants formed good osseointegration at 6 months after surgery,the ISQ value results were 71.67±4.30 for the test group and 72.83±5.63 for the control group,the difference in implant motility between the two groups was not statistically significant(P>0.05),the retention rate of implants in both groups was 100%.(3)Bone volume change at 6 months after surgery: the mean thickness change of labial alveolar bone was(-0.53±0.34)mm in the test group and(-0.51±0.46)mm in the control group,and the difference in the mean thickness change of labial alveolar bone between the two groups was not statistically significant(P>0.05).(4)The peri-implant soft tissue condition at 18 months after surgery: the probing depth,plaque index,and modified bleeding index of the test group were(3.27±0.67)mm,1.21±0.78,and 1.25±0.89,respectively;the probing depth,plaque index,and modified bleeding index of the control group were(3.07±0.47)mm,1.08±0.72,and 1.08±0.83,respectively.0.83,which were not statistically different in both groups(P > 0.05).(5)Satisfaction scores of subjects in both groups: test group: 2.17±0.96;control group: 2.08±1.31,subjects in both groups were more satisfied,and the difference was not statistically significant(P>0.05).Conclusion: The effectiveness of the polylactic acid oral barrier membrane in guiding bone regeneration in the upper anterior region implants is comparable to that of the Bio-Gide collagen membrane and can be clinically selected for use as a barrier membrane in the guided bone regeneration technique. |
PDF Full Text Request