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

Primary Purpose

Periodontal Diseases, Bone Diseases

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated.
guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix.
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring periodontal diseases, Periodontitis, periodontal regeneration

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

collagen membrane associated to anorganic bone

collagen membrane alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

to evaluate clinical attachment level
Change from Baseline in clinical attachment level at +360 days

Secondary Outcome Measures

Tomographic bone gain
Change from Baseline in bone gain at +360 days

Full Information

First Posted
June 21, 2020
Last Updated
June 24, 2020
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04450849
Brief Title
Regenerative Potential of a Collagen Membrane Associated or Not to Bovine Bone in Class II Furcation Defects.
Acronym
RPPCMABBICFD
Official Title
Regenerative Potential of a Collagen Membrane Associated or Not to Bovine Bone in Class II Furcation Defects - A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Bone Diseases
Keywords
periodontal diseases, Periodontitis, periodontal regeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
collagen membrane associated to anorganic bone
Arm Type
Experimental
Arm Description
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
Arm Title
collagen membrane alone
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated.
Other Intervention Name(s)
GTR
Intervention Description
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
Intervention Name(s)
guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix.
Other Intervention Name(s)
GTR
Intervention Description
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.
Primary Outcome Measure Information:
Title
to evaluate clinical attachment level
Description
Change from Baseline in clinical attachment level at +360 days
Time Frame
The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]
Secondary Outcome Measure Information:
Title
Tomographic bone gain
Description
Change from Baseline in bone gain at +360 days
Time Frame
The Tomographic bone gain parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
14040-904
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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