Gingival RecessionNCT03619096
Two Different Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix
A study testing tunnel technique for Root coverage with Porcine collagen Matrix and extended fla technique for Root coverage with Porcine collagen Matrix in people with Gingival Recession and Xenograft Model, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The gold standard for gingival recession treatment is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The porcine collagen matrix (PCR) has been used as a substitute for subepithelial connective tissue graft in periodontal plastic surgery and has achieved similar… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Xenograft Model, Gingival Recession, Generalized
- What is being tested?
- tunnel technique for Root coverage with Porcine collagen Matrix and extended fla technique for Root coverage with Porcine collagen Matrix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Mar 2017to 6 Jul 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm of gingival recession height
Who cannot join
- diabetics
- pregnant women
- chronic use of medication
- periodontitis
- smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparison Between Two Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix
The gold standard for gingival recession treatment is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The porcine collagen matrix (PCR) has been used as a substitute for subepithelial connective tissue graft in periodontal plastic surgery and has achieved similar results. The PCR use has the advantage of avoiding possible pre and postoperative complications , as well as overcome the limitations presented by autograft . The different surgical techniques used for root coverage seek predictability and success . For this, besides the type of incision placements flap and graft are the most important because the healing benefits and outcome .
The aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better clinical outcomes and less morbidity . 20 adults , nonsmoking patients , showing multiple bilateral gingival recessions , class I or II Miller located in canine, first and second premolars are selected. Both techniques use the PCR as a graft . However, in one Quadrant partial flap will be held together with relaxing incisions through an intrasulcular incision, PCR will be positioned 1 mm apical to the cementoenamel junction (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant periosteal envelope that does not use relaxing incisions, avoiding any scars, will be performed with the PCR. The clinical parameters (gingival recession height and width, keratinized tissue thickness and width) will be evaluated 2 weeks after basic periodontal therapy and after 6 and 12 months to surgical procedures..
- Being tested
- tunnel technique for Root coverage with Porcine collagen Matrix, extended fla technique for Root coverage with Porcine collagen Matrix
- Keywords
- Gingival recession, porcine collagen matrix, multiple gingival recessions, tunnel technique
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tunnel technique for Root coverage with Porcine collagen MatrixProcedure or surgery
Also called mucograft matrix
Tunnel technique for root coverage for multiple gingival recessions, using porcine collagen matrix
extended fla technique for Root coverage with Porcine collagen MatrixProcedure or surgery
Also called mucograft matrix
Extended flap technique for root coverage for multiple gingival recessions, using porcine collagen matrix
| Study group | Role | What they receive |
|---|---|---|
| Test Group (tunnel technique) | Active comparator | It Will be performed root coverage of multiple recessions using porcine collagen matrix with a tunnel Technique Receives: Procedure: tunnel technique for Root coverage with Porcine collagen Matrix |
| Control Group (extended flap technique) | Placebo comparator | It Will be performed root coverage of multiple recessions using porcine collagen matrix with a extended flap technique Receives: Procedure: extended fla technique for Root coverage with Porcine collagen Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival recession height (mm)
Gingival recession height will be measured at baseline, 6 months, and 12 months. The primary outcome will be the change in gingival recession height from baseline to 12 months.
Measured: baseline, 6, and 12 months
Secondary outcomes (1)
Keratinized tissue width and thickness (mm)
Keratinized tissue width and thickness will be measured at baseline, 6 months, and 12 months.
Measured: baseline, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start6 Mar 2017
- Primary completion6 Jun 2018
- Study completion6 Jul 2019 (estimated)
Why it stopped: The study received ethics approval but was never initiated. No participants were enrolled.
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.
- 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
- Single group
- Model description
- Split Mouth clinical trial, comparing two different techniques. One side, the tunnel technique will be performed and on the other side, extended flap will be performed. Both surgical techniques will use Porcine Collagen Matrix.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 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
- Investigators
- Arthur Belem Novaes JR, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619096
- Sponsor's protocol ID
- CAAE:65396417000005419
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2018
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison Between Two Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix
- ClinicalTrials.gov ID
- NCT03619096
- Acronym / sponsor ID
- CAAE:65396417000005419
- Keywords
- Gingival recession, porcine collagen matrix, multiple gingival recessions, tunnel technique
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study received ethics approval but was never initiated. No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 6 Jul 2019 (estimated)
- First posted
- 7 Aug 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.
The gold standard for gingival recession treatment is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The porcine collagen matrix (PCR) has been used as a substitute for subepithelial connective tissue graft in periodontal plastic surgery and has achieved similar results. The PCR use has the advantage of avoiding possible pre and postoperative complications , as well as overcome the limitations presented by autograft . The different surgical techniques used for root coverage seek predictability and success . For this, besides the type of incision placements flap and graft are the most important because the healing benefits and outcome .
The aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better clinical outcomes and less morbidity . 20 adults , nonsmoking patients , showing multiple bilateral gingival recessions , class I or II Miller located in canine, first and second premolars are selected. Both techniques use the PCR as a graft . However, in one Quadrant partial flap will be held together with relaxing incisions through an intrasulcular incision, PCR will be positioned 1 mm apical to the cementoenamel junction (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant periosteal envelope that does not use relaxing incisions, avoiding any scars, will be performed with the PCR. The clinical parameters (gingival recession height and width, keratinized tissue thickness and width) will be evaluated 2 weeks after basic periodontal therapy and after 6 and 12 months to surgical procedures..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split Mouth clinical trial, comparing two different techniques. One side, the tunnel technique will be performed and on the other side, extended flap will be performed. Both surgical techniques will use Porcine Collagen Matrix.
| Arm | Type | Receives |
|---|---|---|
| Test Group (tunnel technique) | Active comparator | Procedure: tunnel technique for Root coverage with Porcine collagen MatrixIt Will be performed root coverage of multiple recessions using porcine collagen matrix with a tunnel Technique |
| Control Group (extended flap technique) | Placebo comparator | Procedure: extended fla technique for Root coverage with Porcine collagen MatrixIt Will be performed root coverage of multiple recessions using porcine collagen matrix with a extended flap technique |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm of gingival recession height
Key exclusion criteria (5 listed)
- diabetics
- pregnant women
- chronic use of medication
- periodontitis
- smokers
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 |
|---|---|---|
| tunnel technique for Root coverage with Porcine collagen MatrixAlso: mucograft matrixTunnel technique for root coverage for multiple gingival recessions, using porcine collagen matrix | Procedure or surgery | Test Group (tunnel technique) |
| extended fla technique for Root coverage with Porcine collagen MatrixAlso: mucograft matrixExtended flap technique for root coverage for multiple gingival recessions, using porcine collagen matrix | Procedure or surgery | Control Group (extended flap technique) |
Primary outcome
Change in gingival recession height (mm)
Time frame: baseline, 6, and 12 months
Gingival recession height will be measured at baseline, 6 months, and 12 months. The primary outcome will be the change in gingival recession height from baseline to 12 months.
1 secondary outcome
Keratinized tissue width and thickness (mm)
Time frame: baseline, 6, and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Gingival Recession
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Gingival Recession Localized Moderate, Dental Implant
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
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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.
Arthur Belem Novaes JR principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tunnel technique for Root coverage with Porcine collagen Matrix and extended fla technique for Root coverage with Porcine collagen Matrix in people with Gingival Recession and Xenograft Model, 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 1 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: withdrawn, as of the sponsor's last update on 15 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 was withdrawn before enrolling participants, so there are no results.
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 gingival recession height (mm) (time frame: baseline, 6, and 12 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 15 Apr 2026.