Periodontal DiseasesPhase 4RPPCMABBICFDNCT04450849
Regenerative Potential of a Collagen Membrane Associated or Not to Bovine Bone in Class II Furcation Defects.
A Phase 4 study testing guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated. and guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix. in people with Periodontal Diseases and Bone Diseases, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Bone Diseases
- What is being tested?
- guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated. and guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2018to 20 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regenerative Potential of a Collagen Membrane Associated or Not to Bovine Bone in Class II Furcation Defects - A Randomized Clinical Trial.
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).
Read the 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.
- Conditions
- Periodontal Diseases, Bone Diseases
- Being tested
- 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.
- Keywords
- periodontal diseases, Periodontitis, periodontal regeneration
- Medical subject headings
- Periodontal Diseases, Bone Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated.Procedure or surgery
Also called GTR
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.Procedure or surgery
Also called GTR
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.
| Study group | Role | What they receive |
|---|---|---|
| collagen membrane associated to anorganic bone | Experimental | 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 Receives: Procedure: guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated. |
| collagen membrane alone | Active comparator | 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 Receives: Procedure: guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix. |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate clinical attachment level
Change from Baseline in clinical attachment level at +360 days
Measured: The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]
Secondary outcomes (1)
Tomographic bone gain
Change from Baseline in bone gain at +360 days
Measured: The Tomographic bone gain parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start10 Jan 2018
- Primary completion15 Jun 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Luis Scombatti de Souza, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450849
- Sponsor's protocol ID
- 2008.1.1259.58.9
- Acronym
- RPPCMABBICFD
- Status last verified
- Jun 2020
- First submitted
- 21 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Potential of a Collagen Membrane Associated or Not to Bovine Bone in Class II Furcation Defects - A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04450849
- Acronym / sponsor ID
- RPPCMABBICFD / 2008.1.1259.58.9
- Conditions
- Periodontal Diseases, Bone Diseases
- Keywords
- periodontal diseases, Periodontitis, periodontal regeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| collagen membrane associated to anorganic bone | Experimental | Procedure: guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated.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 |
| collagen membrane alone | Active comparator | Procedure: guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix.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 |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated.Also: GTRDental 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). | Procedure or surgery | collagen membrane associated to anorganic bone |
| guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix.Also: GTRdental 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. | Procedure or surgery | collagen membrane alone |
Primary outcome
to evaluate clinical attachment level
Time frame: The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]
Change from Baseline in clinical attachment level at +360 days
1 secondary outcome
Tomographic bone gain
Time frame: The Tomographic bone gain parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated. and guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix. in people with Periodontal Diseases and Bone Diseases, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate clinical attachment level (time frame: The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.