Gingival RecessionNCT01175720
Clinical Comparison Between Two Surgical Techniques for the Treatment of Gingival Recessions
A study testing Periodontal surgery to gingival recessions in people with Gingival Recession, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study is to test a surgical technique for the treatment of gingival recessions. The hypothesis of the study is to promote greater root coverage and better healing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Periodontal surgery to gingival recessions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Oct 2011
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recession defects are Miller's class I or II and do not vary more or equal than 3 mm
- Main complaint aesthetic issues or dentine hypersensitivity
- The patient must be a candidate for bilateral root coverage procedure
- Patient shows sufficient plaque control (FMPS < 20%)
- The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
- The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent
Who cannot join
- Smokers
- Systemic diseases
- Pregnants or lactating
- Periodontal disease
- General contraindications for dental and/or surgical treatment are present
- The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
- The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Dentistry of Ribeirão Preto USP
Ribeirão Preto, São Paulo, 14040-904
About this study
Official title: Clinical Comparison Between Two Surgical Techniques With Acellular Dermal Matrix Graft in the Treatment of Gingival Recessions
The aim of this study is to test a surgical technique for the treatment of gingival recessions. The hypothesis of the study is to promote greater root coverage and better healing.
- Conditions
- Gingival Recession
- Being tested
- Periodontal surgery to gingival recessions
- Keywords
- gingival recession, acellular dermal matrix graft, root coverage
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal surgery to gingival recessionsProcedure or surgery
Test and control technique to treat gingival recessions.
| Study group | Role | What they receive |
|---|---|---|
| test and control | Experimental | The test and control technique will be tested in a split-mouth design. Receives: Procedure: Periodontal surgery to gingival recessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of root coverage
Clinical parameters will be assessed after 6 months of surgical procedures.
Measured: 6 months
Secondary outcomes (1)
Keratinized Tissue
Clinical parameters will be assessed after 6 months of surgical procedures.
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 posted5 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2011
- Study completionOct 2011
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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Arthur Belem Novaes Jr, University of Sao Paulo
- Investigators
- Arthur B. Novaes Júnior, PhD, Principal investigator, University of Sao PauloLauro G. Ayub, MSD student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175720
- Sponsor's protocol ID
- lga030183
- Status last verified
- Nov 2011
- First submitted
- 3 Aug 2010
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ayub LG, Ramos UD, Reino DM, Grisi MF, Taba M Jr, Souza SL, Palioto DB, Novaes AB Jr. A Randomized comparative clinical study of two surgical procedures to improve root coverage with the acellular dermal matrix graft. J Clin Periodontol. 2012 Sep;39(9):871-8. doi: 10.1111/j.1600-051X.2012.01915.x. Epub 2012 Jun 19.
PubMed 22712624
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison Between Two Surgical Techniques With Acellular Dermal Matrix Graft in the Treatment of Gingival Recessions
- ClinicalTrials.gov ID
- NCT01175720
- Acronym / sponsor ID
- lga030183
- Conditions
- Gingival Recession
- Keywords
- gingival recession, acellular dermal matrix graft, root coverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 5 Aug 2010 (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 is to test a surgical technique for the treatment of gingival recessions. The hypothesis of the study is to promote greater root coverage and better healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| test and control | Experimental | Procedure: Periodontal surgery to gingival recessionsThe test and control technique will be tested in a split-mouth design. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Recession defects are Miller's class I or II and do not vary more or equal than 3 mm
- Main complaint aesthetic issues or dentine hypersensitivity
- The patient must be a candidate for bilateral root coverage procedure
- Patient shows sufficient plaque control (FMPS < 20%)
- The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
Key exclusion criteria (7 listed)
- Smokers
- Systemic diseases
- Pregnants or lactating
- Periodontal disease
- General contraindications for dental and/or surgical treatment are present
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 |
|---|---|---|
| Periodontal surgery to gingival recessionsTest and control technique to treat gingival recessions. | Procedure or surgery | test and control |
Primary outcome
Percentage of root coverage
Time frame: 6 months
Clinical parameters will be assessed after 6 months of surgical procedures.
1 secondary outcome
Keratinized Tissue
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 16 Nov 2011.
- Derived from this study: PubMed 22712624Ayub LG, Ramos UD, Reino DM, Grisi MF, Taba M Jr, Souza SL, Palioto DB, Novaes AB Jr. A Randomized comparative clinical study of two surgical procedures to improve root coverage with the acellular dermal matrix graft. J Clin Periodontol. 2012 Sep;39(9):871-8. doi: 10.1111/j.1600-051X.2012.01915.x. Epub 2012 Jun 19.
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
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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 B. Novaes Júnior, PhD principal investigator
University of Sao Paulo
Lauro G. Ayub, MSD student 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 Periodontal surgery to gingival recessions 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 6 inclusion and 7 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 16 Nov 2011. 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?
Percentage of root coverage (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 NCT01175720, 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 16 Nov 2011.