Gingival RecessionPhase 4NCT02242500
Coronally Advanced Flap With or Without Porcine Collagen Matrix for Root Coverage
A Phase 4 study testing Coronally Advanced Flap and Mucograft in people with Gingival Recession, run by Enilson Antonio Sallum at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the clinical outcomes after coronally advanced flap technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of single gingival recessions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Coronally Advanced Flap and Mucograft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2010to Oct 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Presence of at least one Class I or II Miller gingival recession ≥ 2 mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep non-carious cervical lesions (< 0.5 mm): A + (Pini-Prato et al. 2010).
- Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.
- Full-mouth visible plaque index ≤ 20% (Ainamo \& Bay 1975).
- Full-mouth sulcus bleeding index ≤ 20% (Mühlemann \& Son 1971).
Who cannot join
- Smoking.
- Pregnancy.
- Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery).
- Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair).
- Previous periodontal surgery in the area.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, 13414-903
About this study
Official title: Phase IV Study of Coronally Advanced Flap With or Without Porcine Collagen Matrix for Treatment of Gingival Recession: a Randomized Controlled Clinical Trial
The purpose of this study is to compare the clinical outcomes after coronally advanced flap technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of single gingival recessions. For this blinded randomized controlled clinical trial, 40 patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters evaluated will be probing depth, clinical attachment level, gingival recession height, height and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45 days, 2, 3 and 6 months after surgery.
- Conditions
- Gingival Recession
- Being tested
- Coronally Advanced Flap, Mucograft
- Keywords
- Gingival recession/surgery, Collagen/therapeutic use, Root coverage, Treatment outcome
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally Advanced FlapProcedure or surgery
MucograftDevice
Also called Porcine collagen matrix for soft tissue regeneration
| Study group | Role | What they receive |
|---|---|---|
| Coronally advanced flap + Mucograft | Experimental | coronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft Receives: Procedure: Coronally Advanced Flap; Device: Mucograft |
| Coronally advanced flap | Other | Coronally advanced flap procedure alone Receives: Procedure: Coronally Advanced Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession Reduction
Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.
Measured: 6 months
Secondary outcomes (1)
Complete root coverage
Assessed as percentage of sites with complete root coverage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startDec 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enilson Antonio Sallum
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor-investigator, Enilson Antonio Sallum, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242500
- Sponsor's protocol ID
- 130/2010
- Status last verified
- Dec 2015
- First submitted
- 13 Sep 2014
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Coronally Advanced Flap With or Without Porcine Collagen Matrix for Treatment of Gingival Recession: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02242500
- Acronym / sponsor ID
- 130/2010
- Conditions
- Gingival Recession
- Keywords
- Gingival recession/surgery, Collagen/therapeutic use, Root coverage, Treatment outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Enilson Antonio SallumUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- Dec 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Sep 2014 (estimated)
- 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.
The purpose of this study is to compare the clinical outcomes after coronally advanced flap technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of single gingival recessions. For this blinded randomized controlled clinical trial, 40 patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters evaluated will be probing depth, clinical attachment level, gingival recession height, height and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45 days, 2, 3 and 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronally advanced flap + Mucograft | Experimental | Procedure: Coronally Advanced Flap, Device: Mucograftcoronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft |
| Coronally advanced flap | Other | Procedure: Coronally Advanced FlapCoronally advanced flap procedure alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Presence of at least one Class I or II Miller gingival recession ≥ 2 mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep non-carious cervical lesions (< 0.5 mm): A + (Pini-Prato et al. 2010).
- Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.
- Full-mouth visible plaque index ≤ 20% (Ainamo \& Bay 1975).
- Full-mouth sulcus bleeding index ≤ 20% (Mühlemann \& Son 1971).
Key exclusion criteria (5 listed)
- Smoking.
- Pregnancy.
- Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery).
- Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair).
- Previous periodontal surgery in the area.
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 |
|---|---|---|
| Coronally Advanced Flap | Procedure or surgery | Coronally advanced flap, Coronally advanced flap + Mucograft |
| MucograftAlso: Porcine collagen matrix for soft tissue regeneration | Device | Coronally advanced flap + Mucograft |
Primary outcome
Recession Reduction
Time frame: 6 months
Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.
1 secondary outcome
Complete root coverage
Time frame: 6 months
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 29 Dec 2015.
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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 Coronally Advanced Flap and Mucograft in people with Gingival Recession, run by Enilson Antonio Sallum 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 5 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 29 Dec 2015. 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?
Recession Reduction (time frame: 6 months). 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 29 Dec 2015.