Gingival RecessionPhase 4NCT02459704
Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Gingival Recessions
A Phase 4 study testing Semilunar coronally positioned flap and Enamel matrix derivative (Emdogain) in people with Gingival Recession, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be assigned in two groups. 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?
- Semilunar coronally positioned flap and Enamel matrix derivative (Emdogain)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Aug 2015
- 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 Miller Class I gingival recession ≥ 2 mm or ≤ 4mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ);
- Height of keratinized tissue ≥ 2 mm;
- 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: Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Miller Class I Gingival Recessions: Randomized Clinical Trial
The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be assigned in two groups. Half of patients will receive EMD associated to SCPF, while the other half, will receive SCPF alone.
Read the detailed description
The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be selected, randomized and allocated in two groups: test group (SCPF + EMD) and control group (SCPF). The subjects will should present buccal Miller class I gingival recessions with height greater than or equal to 2.0 mm and less than to 4.0 mm in maxillary canines or premolars. Clinical parameters will be evaluated: gingival recession height (GRH), gingival recession width(GRW), clinical attachment level (CAL), probing depth (PD), height (HKT) and thickness (TKT) of keratinized tissue and papillas height (HP) and width(LP), as well as plaque and gingival index. These data will be collected at baseline and 180 days after surgery.
- Conditions
- Gingival Recession
- Being tested
- Semilunar coronally positioned flap, Enamel matrix derivative (Emdogain)
- Keywords
- Gingival Recession, Semilunar flap, Enamel matrix derivative, 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.
Semilunar coronally positioned flapProcedure or surgery
Semilunar coronally positioned flap with enamel matrix derivative (Emdogain) or alone.
Enamel matrix derivative (Emdogain)Device
Enamel matrix derivative associated to semilunar coronally positioned flap (SCPF + EMD - test group)
| Study group | Role | What they receive |
|---|---|---|
| SCPF + EMD (TEST) | Experimental | Semilunar coronally positioned flap with Enamel matrix derivative (Emdogain) Receives: Procedure: Semilunar coronally positioned flap; Device: Enamel matrix derivative (Emdogain) |
| SCPF (CONTROL) | Active comparator | Semilunar coronally positioned flap alone Receives: Procedure: Semilunar coronally positioned flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Recession Reduction as measured by difference between gingival recession depth
Measured as a difference between gingival recession depth at baseline and gingival recession at 6 months follow-up.
Measured: Baseline, 12 months
Secondary outcomes (1)
Complete root coverage
Assessed as percentage of sites with complete root coverage
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionAug 2015
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enilson Antonio Sallum, University of Campinas, Brazil
- Investigators
- Enilson A Sallum, PhD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459704
- Sponsor's protocol ID
- 038/2012
- Other IDs
- 2013/13098-9
- Status last verified
- May 2015
- First submitted
- 25 May 2015
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Franca-Grohmann IL, Sangiorgio JPM, Bueno MR, Casarin RCV, Silverio KG, Nociti FH Jr, Casati MZ, Sallum EA. Does enamel matrix derivative application improve clinical outcomes after semilunar flap surgery? A randomized clinical trial. Clin Oral Investig. 2019 Feb;23(2):879-887. doi: 10.1007/s00784-018-2506-y. Epub 2018 Jun 12.
PubMed 29948276
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Miller Class I Gingival Recessions: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02459704
- Acronym / sponsor ID
- 038/2012
- Conditions
- Gingival Recession
- Keywords
- Gingival Recession, Semilunar flap, Enamel matrix derivative, Periodontal regeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Jun 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 aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be assigned in two groups. Half of patients will receive EMD associated to SCPF, while the other half, will receive SCPF alone.
Detailed description
The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be selected, randomized and allocated in two groups: test group (SCPF + EMD) and control group (SCPF). The subjects will should present buccal Miller class I gingival recessions with height greater than or equal to 2.0 mm and less than to 4.0 mm in maxillary canines or premolars. Clinical parameters will be evaluated: gingival recession height (GRH), gingival recession width(GRW), clinical attachment level (CAL), probing depth (PD), height (HKT) and thickness (TKT) of keratinized tissue and papillas height (HP) and width(LP), as well as plaque and gingival index. These data will be collected at baseline and 180 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCPF + EMD (TEST) | Experimental | Procedure: Semilunar coronally positioned flap, Device: Enamel matrix derivative (Emdogain)Semilunar coronally positioned flap with Enamel matrix derivative (Emdogain) |
| SCPF (CONTROL) | Active comparator | Procedure: Semilunar coronally positioned flapSemilunar coronally positioned flap alone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years;
- Presence of at least one Miller Class I gingival recession ≥ 2 mm or ≤ 4mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ);
- Height of keratinized tissue ≥ 2 mm;
- Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus;
- Full-mouth visible plaque index ≤ 20% (Ainamo \& Bay 1975);
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 |
|---|---|---|
| Semilunar coronally positioned flapSemilunar coronally positioned flap with enamel matrix derivative (Emdogain) or alone. | Procedure or surgery | SCPF (CONTROL), SCPF + EMD (TEST) |
| Enamel matrix derivative (Emdogain)Enamel matrix derivative associated to semilunar coronally positioned flap (SCPF + EMD - test group) | Device | SCPF + EMD (TEST) |
Primary outcome
Change in Recession Reduction as measured by difference between gingival recession depth
Time frame: Baseline, 12 months
Measured as a difference between gingival recession depth at baseline and gingival recession at 6 months follow-up.
1 secondary outcome
Complete root coverage
Time frame: 12 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 8 Oct 2015.
- Derived from this study: PubMed 29948276Franca-Grohmann IL, Sangiorgio JPM, Bueno MR, Casarin RCV, Silverio KG, Nociti FH Jr, Casati MZ, Sallum EA. Does enamel matrix derivative application improve clinical outcomes after semilunar flap surgery? A randomized clinical trial. Clin Oral Investig. 2019 Feb;23(2):879-887. doi: 10.1007/s00784-018-2506-y. Epub 2018 Jun 12.
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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 principal investigator
University of Campinas, Brazil
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 Semilunar coronally positioned flap and Enamel matrix derivative (Emdogain) 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 6 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 8 Oct 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?
Change in Recession Reduction as measured by difference between gingival recession depth (time frame: Baseline, 12 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 NCT02459704, 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 8 Oct 2015; AzTrials last refreshed its copy on 4 Nov 2026.