Gingival RecessionNCT03675334
Mucoderm or Connective Tissue Graft for Treatment of Gingival Recessions
A study testing Root coverage with collagen matrix graft, Root coverage with subepithelial connective tissue graft and Basic periodontal treatment in people with Gingival Recession, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Coronally advanced flap plus connective tissue graft (CTG) is the gold standard therapy for root coverage. The bioabsorbable porcine collagen matrix (CM) has been widely used in periodontal and mucogingival surgery as a substitute for CTG and has achieved similar results. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Root coverage with collagen matrix graft, Root coverage with subepithelial connective tissue graft and Basic periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2016to Jan 2019
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- CEJ without significant damage;
- localized bilateral RT1 gingival recession ≥3 mm in the same arch
Who cannot join
- previous periodontal surgical treatment on the involved sites;
- smokers
- pregnants or lactating
- compromised systemic health and contraindications for periodontal surgery
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry of Ribeirao Preto - University of Sao Paulo
Ribeirão Preto, São Paulo
About this study
Official title: Clinical Comparison Between the Use of a Connective Tissue Graft or a Porcine Collagen Matrix (Mucoderm) for Treatment of Gingival Recessions Type 1: a Randomized Controlled Clinical Study.
Coronally advanced flap plus connective tissue graft (CTG) is the gold standard therapy for root coverage. The bioabsorbable porcine collagen matrix (CM) has been widely used in periodontal and mucogingival surgery as a substitute for CTG and has achieved similar results. The CM has the advantage of no need of a second surgical area and availability overcoming the limitations of donor site in autograft.
The aim of this study is to investigate the use of Mucoderm® in root coverage procedures combined with extended coronally positioned flap (ECAF), test group (TG), in comparison to the connective tissue graft associated with the ECAF, control group (CG).
- Conditions
- Gingival Recession
- Being tested
- Root coverage with collagen matrix graft, Root coverage with subepithelial connective tissue graft, Basic periodontal treatment
- Keywords
- clinical trial, root coverage, biomaterials, collagen matrix, coronally advanced flap
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root coverage with collagen matrix graftProcedure or surgery
at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.
Root coverage with subepithelial connective tissue graftProcedure or surgery
at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.
Basic periodontal treatmentOther
profilaxis, coronary polishing and scaling and root planning
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Active comparator | Active comparator: gingival recession
the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions Receives: Procedure: Root coverage with collagen matrix graft; Other: Basic periodontal treatment |
| Control Group | Placebo comparator | the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions. The control group was treated with the same technique as the collagen matrix graft. Receives: Procedure: Root coverage with subepithelial connective tissue graft; Other: Basic periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root coverage after 6 months
Root coverage is measured by the difference between the gingival recession height at 6 months and baseline
Measured: 6 months
Secondary outcomes (1)
Keratinized tissue gain after 6 months
The difference between keratinized tissue width and depth at 6 months and at baseline
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Apr 2016
- Primary completionJan 2019
- Study completionJan 2019
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Split-mouth clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Belem Novaes Jr, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675334
- Sponsor's protocol ID
- CAAE 58534216.5.0000.5419
- Status last verified
- Apr 2026
- First submitted
- 10 Sep 2018
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Suzuki KT, de Jesus Hernandez Martinez C, Suemi MI, Palioto DB, Messora MR, de Souza SLS, Novaes AB Jr, Chaves Furlaneto FA, Taba M Jr. Root coverage using coronally advanced flap with porcine-derived acellular dermal matrix or subepithelial connective tissue graft: a randomized controlled clinical trial. Clin Oral Investig. 2020 Nov;24(11):4077-4087. doi: 10.1007/s00784-020-03280-x. Epub 2020 May 7.
PubMed 32382931
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison Between the Use of a Connective Tissue Graft or a Porcine Collagen Matrix (Mucoderm) for Treatment of Gingival Recessions Type 1: a Randomized Controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT03675334
- Acronym / sponsor ID
- CAAE 58534216.5.0000.5419
- Conditions
- Gingival Recession
- Keywords
- clinical trial, root coverage, biomaterials, collagen matrix, coronally advanced flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 18 Sep 2018 (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.
Coronally advanced flap plus connective tissue graft (CTG) is the gold standard therapy for root coverage. The bioabsorbable porcine collagen matrix (CM) has been widely used in periodontal and mucogingival surgery as a substitute for CTG and has achieved similar results. The CM has the advantage of no need of a second surgical area and availability overcoming the limitations of donor site in autograft.
The aim of this study is to investigate the use of Mucoderm® in root coverage procedures combined with extended coronally positioned flap (ECAF), test group (TG), in comparison to the connective tissue graft associated with the ECAF, control group (CG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Split-mouth clinical trial
| Arm | Type | Receives |
|---|---|---|
| Test Group | Active comparator | Procedure: Root coverage with collagen matrix graft, Other: Basic periodontal treatmentActive comparator: gingival recession the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions |
| Control Group | Placebo comparator | Procedure: Root coverage with subepithelial connective tissue graft, Other: Basic periodontal treatmentthe aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions. The control group was treated with the same technique as the collagen matrix graft. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- CEJ without significant damage;
- localized bilateral RT1 gingival recession ≥3 mm in the same arch
Key exclusion criteria (4 listed)
- previous periodontal surgical treatment on the involved sites;
- smokers
- pregnants or lactating
- compromised systemic health and contraindications for periodontal surgery
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 |
|---|---|---|
| Root coverage with collagen matrix graftat one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft. | Procedure or surgery | Test Group |
| Root coverage with subepithelial connective tissue graftat one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft. | Procedure or surgery | Control Group |
| Basic periodontal treatmentprofilaxis, coronary polishing and scaling and root planning | Other | Control Group, Test Group |
Primary outcome
Root coverage after 6 months
Time frame: 6 months
Root coverage is measured by the difference between the gingival recession height at 6 months and baseline
1 secondary outcome
Keratinized tissue gain after 6 months
Time frame: 6months
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 14 Apr 2026.
- Derived from this study: PubMed 32382931Suzuki KT, de Jesus Hernandez Martinez C, Suemi MI, Palioto DB, Messora MR, de Souza SLS, Novaes AB Jr, Chaves Furlaneto FA, Taba M Jr. Root coverage using coronally advanced flap with porcine-derived acellular dermal matrix or subepithelial connective tissue graft: a randomized controlled clinical trial. Clin Oral Investig. 2020 Nov;24(11):4077-4087. doi: 10.1007/s00784-020-03280-x. Epub 2020 May 7.
- 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.
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 study testing Root coverage with collagen matrix graft, Root coverage with subepithelial connective tissue graft and Basic periodontal treatment in people with Gingival Recession, 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 2 inclusion and 4 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 14 Apr 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Root coverage after 6 months (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 NCT03675334, 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 14 Apr 2026.