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

NCT ID: NCT04450849

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2020-01-20

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Periodontal Diseases Bone Diseases

Keywords

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periodontal diseases Periodontitis periodontal regeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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collagen membrane associated to anorganic bone

Complete debridement of the osseous defects and thorough scaling and root planing using mini curettes and ultrasonic scalers were performed. The sites were randomly selected for treatment with resorbable collagen membrane (Bio-Gide® Perio) associated to anorganic bovine bone matrix + collagen (Bio-Oss® Collagen) . The membranes were trimmed to cover the lesions and extended to the adjacent bone between 2 to 3 mm apically and laterally. They were then placed in position, 2 mm below the CEJ, and fixed in position using sling 5-0 vicryl sutures. The flaps were coronally positioned until completely covering the membranes without tension and sutured with 5-0 nylon sutures

Group Type EXPERIMENTAL

guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated.

Intervention Type PROCEDURE

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).

collagen membrane alone

Complete debridement of the osseous defects and thorough scaling and root planing using mini curettes and ultrasonic scalers were performed. The sites were randomly selected for treatment with resorbable collagen membrane (Bio-Gide® Perio). The membranes were trimmed to cover the lesions and extended to the adjacent bone between 2 to 3 mm apically and laterally. They were then placed in position, 2 mm below the CEJ, and fixed in position using sling 5-0 vicryl sutures. The flaps were coronally positioned until completely covering the membranes without tension and sutured with 5-0 nylon sutures

Group Type ACTIVE_COMPARATOR

guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix.

Intervention Type PROCEDURE

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.

Interventions

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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).

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

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GTR GTR

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Sergio Luis Scombatti de Souza

Departament of Oral & Maxillofacial Surgery and Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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2008.1.1259.58.9

Identifier Type: -

Identifier Source: org_study_id