Gingival RecessionNCT06006780
Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions
A study testing Porcine acellular dermal matrix and Coronally advanced flap (CAF) in people with Gingival Recession, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Aim: The aim of this randomized clinical trial is to evaluate the use of the porcine acellular dermal matrix (PADM) for the treatment of RT1 localized gingival recessions. Material and methods: Forthy patients (n=20) with RT1 localized gingival recessions with height ranging from 3 to 5 mm with and at least, 2mm of… 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?
- Porcine acellular dermal matrix and Coronally advanced flap (CAF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Sep 2022to 30 Dec 2024
- 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
- RT1 localized gingival recessions with height ranging from 3 to 5 mm;
- 2mm or more of keratinized tissue width ;
- Probing depth less than 3mm;
- Plaque and gingival index less or equal to 20%.
Who cannot join
- Smokers;
- Pregnants;
- Nursing;
- Patients with diabetes mellitus or another condition that interfere in the tissue repair
- Patients who use drugs or medications that interfere in the tissue repair;
- Allergies to any composition of the devices of the study.
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: Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions: A Multicenter Randomized Clinical Trial
Aim: The aim of this randomized clinical trial is to evaluate the use of the porcine acellular dermal matrix (PADM) for the treatment of RT1 localized gingival recessions.
Material and methods: Forthy patients (n=20) with RT1 localized gingival recessions with height ranging from 3 to 5 mm with and at least, 2mm of keratinized tissue width will be selected to participate in the study. Patients will be allocated randomly in two treatment groups: Coronally advanced flap (CAF) or coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM). The clinical parameters evaluated at the baseline, 6 and 12 months will be: Plaque index (IPL); gingival index (GI); relative gingival recession height (RGRH); gingival recession width (GRW); probing depth (PD); relative clinical attachment level (RCAL); keratinized tissue height (KTH); keratinized tissue thickness (KTT); papilla height (PH). Evaluations will be made by the professional and the patient regarding dentin hypersensitivity (HD) (Schiff and VAS scales respectively), aesthetics (RES and VAS scales, respectively) and patient\'s centered outcomes, through the questionnaire referring to the OHIP-14.
Descriptive statistical analysis will be expressed as mean ± standard deviation (SD), median, quartiles, percentages and confidence intervals (95% CI). To analyze the normality of the residue, the Shapiro-Wilk test will be performed. Then, the Wilcoxon test will be applied to compare the periodontal parameters and a quality of life, before and post-treatment. Correlations between parameters and dental hypersensitivity will be analyzed through Spearman\'s test. Key words: Gingival recession, Root coverage, Biomaterial, Acellular dermal matrix.
- Conditions
- Gingival Recession
- Being tested
- Porcine acellular dermal matrix, Coronally advanced flap (CAF)
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porcine acellular dermal matrixDevice
Also called Mucoderm
Coronally advanced flap associated with the porcine acellular dermal matrix for root coverage
Coronally advanced flap (CAF)Other
Coronally advanced flap for root coverage
| Study group | Role | What they receive |
|---|---|---|
| Coronally advanced flap (CAF) | Active comparator | Not described Receives: Other: Coronally advanced flap (CAF) |
| Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM) | Experimental | Not described Receives: Device: Porcine acellular dermal matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession change
Change of the gingival recession height
Measured: Baseline, 6 months and 12 months
Secondary outcomes (1)
Thickness of keratinized tissue
Thickness of keratinized tissue evaluation after periodontal plastic surgery
Measured: Baseline, 6 months 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 posted23 Aug 2023
- Study start10 Sep 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006780
- Sponsor's protocol ID
- 59036822.4.1001.5418
- Status last verified
- Mar 2025
- First submitted
- 17 Aug 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06006780
- Acronym / sponsor ID
- 59036822.4.1001.5418
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 23 Aug 2023 (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.
Aim: The aim of this randomized clinical trial is to evaluate the use of the porcine acellular dermal matrix (PADM) for the treatment of RT1 localized gingival recessions.
Material and methods: Forthy patients (n=20) with RT1 localized gingival recessions with height ranging from 3 to 5 mm with and at least, 2mm of keratinized tissue width will be selected to participate in the study. Patients will be allocated randomly in two treatment groups: Coronally advanced flap (CAF) or coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM). The clinical parameters evaluated at the baseline, 6 and 12 months will be: Plaque index (IPL); gingival index (GI); relative gingival recession height (RGRH); gingival recession width (GRW); probing depth (PD); relative clinical attachment level (RCAL); keratinized tissue height (KTH); keratinized tissue thickness (KTT); papilla height (PH). Evaluations will be made by the professional and the patient regarding dentin hypersensitivity (HD) (Schiff and VAS scales respectively), aesthetics (RES and VAS scales, respectively) and patient\'s centered outcomes, through the questionnaire referring to the OHIP-14.
Descriptive statistical analysis will be expressed as mean ± standard deviation (SD), median, quartiles, percentages and confidence intervals (95% CI). To analyze the normality of the residue, the Shapiro-Wilk test will be performed. Then, the Wilcoxon test will be applied to compare the periodontal parameters and a quality of life, before and post-treatment. Correlations between parameters and dental hypersensitivity will be analyzed through Spearman\'s test. Key words: Gingival recession, Root coverage, Biomaterial, Acellular dermal matrix.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronally advanced flap (CAF) | Active comparator | Other: Coronally advanced flap (CAF) |
| Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM) | Experimental | Device: Porcine acellular dermal matrix |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- RT1 localized gingival recessions with height ranging from 3 to 5 mm;
- 2mm or more of keratinized tissue width ;
- Probing depth less than 3mm;
- Plaque and gingival index less or equal to 20%.
Key exclusion criteria (6 listed)
- Smokers;
- Pregnants;
- Nursing;
- Patients with diabetes mellitus or another condition that interfere in the tissue repair
- Patients who use drugs or medications that interfere in the tissue repair;
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 |
|---|---|---|
| Porcine acellular dermal matrixAlso: MucodermCoronally advanced flap associated with the porcine acellular dermal matrix for root coverage | Device | Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM) |
| Coronally advanced flap (CAF)Coronally advanced flap for root coverage | Other | Coronally advanced flap (CAF) |
Primary outcome
Recession change
Time frame: Baseline, 6 months and 12 months
Change of the gingival recession height
1 secondary outcome
Thickness of keratinized tissue
Time frame: Baseline, 6 months and 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 2 Apr 2025.
- Results publication: 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.
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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 Porcine acellular dermal matrix and Coronally advanced flap (CAF) 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 4 inclusion and 6 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 2 Apr 2025. 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.
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 change (time frame: Baseline, 6 months and 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 NCT06006780, 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 2 Apr 2025.