Regenerative Potential of a Collagen Membrane Associated or Not to Bovine Bone in Class II Furcation Defects.

Periodontal Diseases Clinical Trial

— RPPCMABBICFD  

Official title:

Regenerative Potential of a Collagen Membrane Associated or Not to Bovine Bone in Class II Furcation Defects - A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450849
• Other study ID #: 2008.1.1259.58.9
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2018
• Est. completion date: January 20, 2020

Study information

• Verified date: June 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Periodontal disease is an infectious-inflammatory disease that accommodates the supporting and supporting tissues of the teeth, with the formation of periodontal pockets, and this destruction can generate anatomical defects in the region of bifurcation. Treatment of these lesions is a challenge for the clinician, as this area has limited access to bacterial biofilm and calculus. The surgical regenerative therapy using bone grafts and membrane may be a viable option in cases of class II furcation defects. In this context, the objective of this case series is to evaluate tomographically and clinically the treatment of class II furcation defects using an absorbable collagen membrane (Bio-Gide® Perio) associated or not with inorganic bovine bone associated with collagen matrix (Bio-Oss® Collagen).

Description:

Periodontal disease is an infectious-inflammatory disease that accommodates the supporting and supporting tissues of the teeth, with the formation of periodontal pockets, and this destruction can generate anatomical defects in the region of bifurcation. Treatment of these lesions is a challenge for the clinician, as this area has limited access to bacterial biofilm and calculus. The surgical regenerative therapy using bone grafts and membrane may be a viable option in cases of class II furcation defects. In this context, the objective of this case series is to evaluate tomographically and clinically the treatment of class II furcation defects using an absorbable collagen membrane (Bio-Gide® Perio) associated or not with inorganic bovine bone associated with collagen matrix (Bio-Oss® Collagen). In a parallel design, 22 patients with mandibular class II furcation defects were recruited. Each defect was randomly assigned to the control group (CG - Bio-Gide® Perio, n=11) or test group (TG - Bio-Oss® Collagen + Bio-Gide® Perio, n=11). Tomographic and clinical evaluations were conducted at baseline and 12 months post-surgery. Clinical measurements of clinical attachment level (CAL) and probing depth (PD). Tomographical measurements of horizontal defect dimension (HDD) and vertical defect dimension (VDD) were recorded. In sequence, guided tissue regeneration surgeries were conducted: Then, bone defect were debrided, , the collagen membranes (BioGide Perio®) were trimmed to cover the osseous defects and extended 3 mm apically and laterally to the adjacent bone and sutured with absorbable suture. In the Test Group, the defects were completely filled with bovine bone + porcine collagen (BioOss Collagen®). The flaps were then coronally positioned until completely covering the membranes and sutured. Shapiro-Wilk test was used to evaluate normality of the data, and showed a normal distribution. Then, t-Test was selected for inter-group and intragroup comparisons. Trans-surgical measurements were evaluated at Baseline. The other clinical and tomographic parameters were evaluated at Baseline and 12 months. For all analyzes, p <0.05 was considered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 20, 2020
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• subjects with a diagnosis of periodontitis, Stage III and Grade A (according to the 2018 international classification criteria);

• presence of one mandibular molar with class II buccal furcation defect;

• non-smokers;

• plaque index <20%.

Exclusion Criteria:

• patients that presented systemic diseases;

• patients that had taken antibiotics in the past 6 months prior to surgical procedures;

• pregnant women or lactating mothers;

• furcation involvement in molars with periapical disease;

• cervical restorations or prosthesis closer than 1 mm to fornix.

Related Conditions & MeSH terms

• Bone Diseases
• Furcation Defects
• Periodontal Diseases

Intervention

Procedure:
• guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated.
Dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration. Using an absorbable collagen membrane (Bio-Gide® Perio) associated with inorganic bovine bone associated with collagen matrix (Bio-Oss® Collagen).
• guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix.
dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration. Using an absorbable collagen membrane (Bio-Gide® Perio) alone.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate clinical attachment level	Change from Baseline in clinical attachment level at +360 days	The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]
Secondary	Tomographic bone gain	Change from Baseline in bone gain at +360 days	The Tomographic bone gain parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]