Gingival RecessionNCT01143610
A New Therapeutic Approach for Root Coverage
A study testing Newly forming bone technique for root coverage and Subepithelial connective tissue graft for root coverage. in people with Gingival Recession, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Different surgical techniques have been proposed for root coverage, showing varying results especially in areas of deep recessions. The aim of this study is to evaluate the effectiveness of the newly forming bone technique (NFB)as an alternative treatment for Miller class I or II deep recessions, requiring… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Newly forming bone technique for root coverage and Subepithelial connective tissue graft for root coverage.
- 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
- Feb 2008to Feb 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults with at least one tooth presenting marginal tissue recession equal to or greater than 4mm in depth and one edentulous area or tooth to be extracted.
Who cannot join
- Smokers
- Pregnants
- Use of anti-convulsants, anti-hypertensives, cyclosporine or hormones
- Use of antibiotics for the last 6 months
- Patients under treatment for medical conditions or presenting systemic disorders that would impair treatment results (e.g.: uncontrolled diabetes mellitus)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry at Bauru-USP, Discipline of Periodontics
Bauru, São Paulo, 17012-912
About this study
Official title: A New Regenerative Therapeutic Approach for Root Coverage: a Randomized Clinical Trial
Different surgical techniques have been proposed for root coverage, showing varying results especially in areas of deep recessions. The aim of this study is to evaluate the effectiveness of the newly forming bone technique (NFB)as an alternative treatment for Miller class I or II deep recessions, requiring regeneration of lost periodontal tissues. Sample should be comprised of patients aged 18-45 years, both genders, presenting at least one site with marginal tissue recession >4mm. Patients will be randomly assigned to either one of the groups, based on treatment technique: newly forming bone (NFB) or subepithelial connective tissue graft (SCTG). Clinical examinations will be performed by a single blinded examiner at baseline, 1, 3, 6 and 9 months after surgery. Intra-group analysis will be performed by one way analysis of variance for repeated measures. Inter-group analysis will be performed by unpaired t-test for each of evaluation periods.
Read the detailed description
Both gender patients presenting Miller class I or II recession defects >4mm were selected. Patients were randomly assigned to treatment groups: newly forming bone graft (NFBG) or subepithelial connective tissue graft (SCT). Patients were treated in the period of February 2008 and March 2008 and monitored during 9 months.
- Conditions
- Gingival Recession
- Being tested
- Newly forming bone technique for root coverage, Subepithelial connective tissue graft for root coverage.
- Keywords
- Root coverage, Graft, Soft tissue, 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.
Newly forming bone technique for root coverageProcedure or surgery
Also called Bone granulation, NFBG
A granulation tissue will be obtained 21-25 days after the creation of an alveolar socket and grafted to receptor site.
Subepithelial connective tissue graft for root coverage.Other
Also called SCTG
A subepithelial connective tissue graft will be used for the treatment of Miller class I or II deep recessions.
| Study group | Role | What they receive |
|---|---|---|
| Newly forming bone | Experimental | Miller class I or II deep recessions treated by the newly forming bone technique. Receives: Procedure: Newly forming bone technique for root coverage |
| Subepithelial connective tissue graft | Active comparator | Miller class I or II deep recessions treated by subepithelial connective tissue graft. Receives: Other: Subepithelial connective tissue graft for root coverage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Root Coverage
Percentage of root coverage determined by: [area covered]/[total area to be covered] x 100 (in %)
Measured: Baseline, 9 months post-operatively
Secondary outcomes (1)
Gain of Clinical Attachment Level
Investigation of clinical attachment level, probing depth and reduction of recession depth
Measured: 9 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startFeb 2008
- Primary completionNov 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Adriana Campos Passanezi SantAna, University of Sao Paulo
- Investigators
- Adriana P Sant'Ana, DDS PhD, Principal investigator, School of Dentistry at Bauru, University of São PauloBruna R Ferraz, DDS, Principal investigator, School of Dentistry at Bauru, University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143610
- Sponsor's protocol ID
- 115-2007
- Status last verified
- Jun 2012
- First submitted
- 30 Apr 2010
- Last updated
- 24 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Regenerative Therapeutic Approach for Root Coverage: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01143610
- Acronym / sponsor ID
- 115-2007
- Conditions
- Gingival Recession
- Keywords
- Root coverage, Graft, Soft tissue, Periodontal regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Posted 24 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Different surgical techniques have been proposed for root coverage, showing varying results especially in areas of deep recessions. The aim of this study is to evaluate the effectiveness of the newly forming bone technique (NFB)as an alternative treatment for Miller class I or II deep recessions, requiring regeneration of lost periodontal tissues. Sample should be comprised of patients aged 18-45 years, both genders, presenting at least one site with marginal tissue recession >4mm. Patients will be randomly assigned to either one of the groups, based on treatment technique: newly forming bone (NFB) or subepithelial connective tissue graft (SCTG). Clinical examinations will be performed by a single blinded examiner at baseline, 1, 3, 6 and 9 months after surgery. Intra-group analysis will be performed by one way analysis of variance for repeated measures. Inter-group analysis will be performed by unpaired t-test for each of evaluation periods.
Detailed description
Both gender patients presenting Miller class I or II recession defects >4mm were selected. Patients were randomly assigned to treatment groups: newly forming bone graft (NFBG) or subepithelial connective tissue graft (SCT). Patients were treated in the period of February 2008 and March 2008 and monitored during 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly forming bone | Experimental | Procedure: Newly forming bone technique for root coverageMiller class I or II deep recessions treated by the newly forming bone technique. |
| Subepithelial connective tissue graft | Active comparator | Other: Subepithelial connective tissue graft for root coverage.Miller class I or II deep recessions treated by subepithelial connective tissue graft. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults with at least one tooth presenting marginal tissue recession equal to or greater than 4mm in depth and one edentulous area or tooth to be extracted.
Key exclusion criteria (5 listed)
- Smokers
- Pregnants
- Use of anti-convulsants, anti-hypertensives, cyclosporine or hormones
- Use of antibiotics for the last 6 months
- Patients under treatment for medical conditions or presenting systemic disorders that would impair treatment results (e.g.: uncontrolled diabetes mellitus)
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 |
|---|---|---|
| Newly forming bone technique for root coverageAlso: Bone granulation, NFBGA granulation tissue will be obtained 21-25 days after the creation of an alveolar socket and grafted to receptor site. | Procedure or surgery | Newly forming bone |
| Subepithelial connective tissue graft for root coverage.Also: SCTGA subepithelial connective tissue graft will be used for the treatment of Miller class I or II deep recessions. | Other | Subepithelial connective tissue graft |
Primary outcome
Percentage of Root Coverage
Time frame: Baseline, 9 months post-operatively
Percentage of root coverage determined by: [area covered]/[total area to be covered] x 100 (in %)
1 secondary outcome
Gain of Clinical Attachment Level
Time frame: 9 months post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- School of Dentistry at Bauru, University of São Paulo site informationLink provided by the sponsor.
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
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Gingival Recession
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.
Adriana P Sant'Ana, DDS PhD principal investigator
School of Dentistry at Bauru, University of São Paulo
Bruna R Ferraz, DDS principal investigator
School of Dentistry at Bauru, University of São 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 Newly forming bone technique for root coverage and Subepithelial connective tissue graft for root coverage. 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 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: finished, as of the sponsor's last update on 24 Jul 2012. 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?
Yes. Results are posted in the registry (first posted 24 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Baseline, 9 months post-operatively). 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 24 Jul 2012.