Gingival RecessionPhase 4NCT02456337
Xenogenous Collagen Matrix Graft With or Without Enamel Matrix Proteins Derivative for Root Coverage
A Phase 4 study testing Mucograft, Emdogain and Coronally Advanced flap in people with Gingival Recession, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the reduction of gingival recession of single Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen matrix graft and / or enamel matrix proteins. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Mucograft, Emdogain and Coronally Advanced flap
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Oct 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years.
- Presence of at least one Class I or II Miller gingival recession ≥ 2.5 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: Xenogenous Collagen Matrix Graft Associated or Not With Enamel Matrix Derivative Proteins in the Treatment of Gingival Recession Class I and II of Miller: Randomized Controlled Clinical Study
The purpose of this study is to evaluate the reduction of gingival recession of single Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen matrix graft and / or enamel matrix proteins.
- Conditions
- Gingival Recession
- Being tested
- Mucograft, Emdogain, Coronally Advanced flap
- Keywords
- Gingival Recession, Coronally advanced flap, Periodontal regeneration
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MucograftDevice
Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.
EmdogainDevice
Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.
Coronally Advanced flapProcedure or surgery
Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.
| Study group | Role | What they receive |
|---|---|---|
| CAF+MC+EMD | Experimental | Coronally Advanced Flap with Mucograft and Emdogain Receives: Device: Mucograft; Device: Emdogain; Procedure: Coronally Advanced flap |
| CAF+MC | Active comparator | Coronally Advanced Flap with Mucograft Receives: Device: Mucograft; Procedure: Coronally Advanced flap |
| CAF+EMD | Active comparator | Coronally Advanced Flap with Emdogain Receives: Device: Emdogain; Procedure: Coronally Advanced flap |
| CAF | Active comparator | Coronally Advanced Flap 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 posted28 May 2015 (estimated)
- Study startJul 2014
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Enilson Antonio Sallum, University of Campinas, Brazil
- Investigators
- Enilson A Sallum, PhD, Study chair, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456337
- Sponsor's protocol ID
- 067/2013
- Other IDs
- 2013/19473-6
- Status last verified
- Dec 2015
- First submitted
- 25 May 2015
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sangiorgio JPM, Neves FLDS, Rocha Dos Santos M, Franca-Grohmann IL, Casarin RCV, Casati MZ, Santamaria MP, Sallum EA. Xenogenous Collagen Matrix and/or Enamel Matrix Derivative for Treatment of Localized Gingival Recessions: A Randomized Clinical Trial. Part I: Clinical Outcomes. J Periodontol. 2017 Dec;88(12):1309-1318. doi: 10.1902/jop.2017.170126. Epub 2017 Jul 28.
PubMed 28753100
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xenogenous Collagen Matrix Graft Associated or Not With Enamel Matrix Derivative Proteins in the Treatment of Gingival Recession Class I and II of Miller: Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02456337
- Acronym / sponsor ID
- 067/2013
- Conditions
- Gingival Recession
- Keywords
- Gingival Recession, Coronally advanced flap, Periodontal regeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Jul 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 May 2015 (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 evaluate the reduction of gingival recession of single Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen matrix graft and / or enamel matrix proteins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CAF+MC+EMD | Experimental | Device: Mucograft, Device: Emdogain, Procedure: Coronally Advanced flapCoronally Advanced Flap with Mucograft and Emdogain |
| CAF+MC | Active comparator | Device: Mucograft, Procedure: Coronally Advanced flapCoronally Advanced Flap with Mucograft |
| CAF+EMD | Active comparator | Device: Emdogain, Procedure: Coronally Advanced flapCoronally Advanced Flap with Emdogain |
| CAF | Active comparator | Procedure: Coronally Advanced flapCoronally Advanced Flap alone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Presence of at least one Class I or II Miller gingival recession ≥ 2.5 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 |
|---|---|---|
| MucograftCoronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II. | Device | CAF+MC, CAF+MC+EMD |
| EmdogainCoronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II. | Device | CAF+EMD, CAF+MC+EMD |
| Coronally Advanced flapCoronally advanced flap for the treatment of gingival recessions Miller Class I or II. | Procedure or surgery | CAF, CAF+EMD, CAF+MC, CAF+MC+EMD |
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 27 Oct 2016.
- Derived from this study: PubMed 28753100Sangiorgio JPM, Neves FLDS, Rocha Dos Santos M, Franca-Grohmann IL, Casarin RCV, Casati MZ, Santamaria MP, Sallum EA. Xenogenous Collagen Matrix and/or Enamel Matrix Derivative for Treatment of Localized Gingival Recessions: A Randomized Clinical Trial. Part I: Clinical Outcomes. J Periodontol. 2017 Dec;88(12):1309-1318. doi: 10.1902/jop.2017.170126. Epub 2017 Jul 28.
- Individual participant dataSharing planned: No
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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.
Enilson A Sallum, PhD study chair
University of Campinas
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 Mucograft, Emdogain and Coronally Advanced flap in people with Gingival Recession, run by University of Campinas, Brazil 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 27 Oct 2016. 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?
On the ClinicalTrials.gov record for NCT02456337, which also lists 1 linked publication.
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 27 Oct 2016.