Gingival RecessionPhase 2NCT01814592
Comparison Between Two Coronally Positioned Flap With Connective Tissue
A Phase 2 study testing coronally partial thickness flap plus connective tissue and coronally mucosal thickness flap in people with Gingival Recession and Periodontal Atrophy, run by Universidad El Bosque, Bogotá at 1 site in Colombia.
Trial summary
The aim of this study is to evaluate the effectiveness of total root coverage between two coronally positioned flap technique in Miller recession Class I and II, in patients attending at "Universidad El Bosque" dental school clinics. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Gingival Recession, Periodontal Atrophy
- What is being tested?
- coronally partial thickness flap plus connective tissue and coronally mucosal thickness flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2013to Aug 2014
- Phase
- Phase 2
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Class I and II Miller recessions showing a recession depth ≥ 2 mm.
- Recessions isolated and / or maximum continuous two teeth.
- Recessions in incisors, canines and premolars
- Patients 20 to 60 years old.
Who cannot join
- Systemic compromise, that contraindicates any periodontal surgical procedure.
- Warfarin medication.
- Uncontrolled diabetes mellitus with glycosylated hemoglobin ≥ 8
- Chronic steroid therapy (dose of 7.5 mg/ day for more than 14 days)
- HIV-AIDS infection with CD4 counts <200.
- Immunosuppression.
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- Recessions molars not be taken into account in the study.
- Patients who have used antibiotics one month prior to the surgical procedure.
- Pregnancy.
- Active smoker.
- Patients with a history of periodontal surgery at the recession area that has taken place in the last three months.
- Severe dental malposition, teeth rotation, versions teeth root coverage that contraindicates surgery.
- Non carious cervical lesions or caries where is not visible the cemento- enamel junction (CEJ).
- Active inflammation that contraindicates surgical procedure of the recession.
- Active Orthodontics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Bilaminar Techniques for Root Covering of Miller´s Recessions Class I and II: A Blind, Randomized Controlled Clinical Trial
The aim of this study is to evaluate the effectiveness of total root coverage between two coronally positioned flap technique in Miller recession Class I and II, in patients attending at "Universidad El Bosque" dental school clinics.
Read the detailed description
This is a blind, randomized controlled clinical trial.
- Conditions
- Gingival Recession, Periodontal Atrophy
- Being tested
- coronally partial thickness flap plus connective tissue, coronally mucosal thickness flap
- Keywords
- coronally positioned flap, connective tissue, gingival margin, gingival recession/ treatment, gingival recession/ surgery, subepithelial connective tissue graft, randomized controlled clinical trial, surgical flaps, Treatment outcome
- Medical subject headings
- Gingival Recession, Periodontal Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronally partial thickness flap plus connective tissueProcedure or surgery
Also called subepithelial connective tissue graft, coronally positioned flap
The design of the flap will be performed according to the technique described by de Sanctis and Zucchelli 2007.
coronally mucosal thickness flapProcedure or surgery
Also called superficial-layer split-tihickness flap
The design of the flap will be performed according to the technique described by Greenwell H, Vance G, Munninger B and Johnston H.
| Study group | Role | What they receive |
|---|---|---|
| coronally mucosal thickness flap | Experimental | coronally mucosal thickness flap plus connective tissue graft for root coverage (subepithelial connective tissue graft) Receives: Procedure: coronally mucosal thickness flap |
| coronally partial thickness flap | Active comparator | coronally partial thickness flap plus connective tissue for root coverage (subepithelial connective tissue graft) Receives: Procedure: coronally partial thickness flap plus connective tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess percentage of total root coverage between two subepithelial conective tissue graft technique for covering Class I and II Miller recessions patients attending at dental clinics of "Universidad El Bosque"
Measured: one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)
Secondary outcomes (2)
Assess the proportion of root coverage
Measured: one month (plus or minus 2 days), Three months (plus or minus 3 days) and six month (plus or minus 5 days)
Clinical attachment level, width of keratinized tissue and the position of the mucogingival junction following root coverage procedures
Measured: one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2014 (estimated)
- Study completionAug 2014 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad El Bosque, Bogotá
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Iván Losada Amaya, Universidad El Bosque, Bogotá
- Investigators
- Sergio I Losada Amaya, Professor, Principal investigator, Universidad El bosque- UNIECLOJaime A Marquez Cristo, Professor, Study chair, Universidad El Bosque- UNIECLOMiguel F Vargas del Campo, Professor, Study chair, Universidad El Bosque- UNIECLOSilie S Arboleda Salaiman, Professor, Study chair, Universidad El Bosque- UNIECLOMaria I Pardo Silva, Professor, Study director, Universidad El Bosque- UNIECLO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814592
- Sponsor's protocol ID
- PCI-2012-359
- Status last verified
- Mar 2013
- First submitted
- 11 Mar 2013
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Bilaminar Techniques for Root Covering of Miller´s Recessions Class I and II: A Blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01814592
- Acronym / sponsor ID
- PCI-2012-359
- Conditions
- Gingival Recession, Periodontal Atrophy
- Keywords
- coronally positioned flap, connective tissue, gingival margin, gingival recession/ treatment, gingival recession/ surgery, subepithelial connective tissue graft, randomized controlled clinical trial, surgical flaps
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universidad El Bosque, BogotáUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 20 Mar 2013 (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 evaluate the effectiveness of total root coverage between two coronally positioned flap technique in Miller recession Class I and II, in patients attending at "Universidad El Bosque" dental school clinics.
Detailed description
This is a blind, randomized controlled clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coronally mucosal thickness flap | Experimental | Procedure: coronally mucosal thickness flapcoronally mucosal thickness flap plus connective tissue graft for root coverage (subepithelial connective tissue graft) |
| coronally partial thickness flap | Active comparator | Procedure: coronally partial thickness flap plus connective tissuecoronally partial thickness flap plus connective tissue for root coverage (subepithelial connective tissue graft) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Class I and II Miller recessions showing a recession depth ≥ 2 mm.
- Recessions isolated and / or maximum continuous two teeth.
- Recessions in incisors, canines and premolars
- Patients 20 to 60 years old.
Key exclusion criteria (15 listed)
- Systemic compromise, that contraindicates any periodontal surgical procedure.
- Recessions molars not be taken into account in the study.
- Patients who have used antibiotics one month prior to the surgical procedure.
- Pregnancy.
- Active smoker.
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 |
|---|---|---|
| coronally partial thickness flap plus connective tissueAlso: subepithelial connective tissue graft, coronally positioned flapThe design of the flap will be performed according to the technique described by de Sanctis and Zucchelli 2007. | Procedure or surgery | coronally partial thickness flap |
| coronally mucosal thickness flapAlso: superficial-layer split-tihickness flapThe design of the flap will be performed according to the technique described by Greenwell H, Vance G, Munninger B and Johnston H. | Procedure or surgery | coronally mucosal thickness flap |
Primary outcome
Assess percentage of total root coverage between two subepithelial conective tissue graft technique for covering Class I and II Miller recessions patients attending at dental clinics of "Universidad El Bosque"
Time frame: one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)
2 secondary outcomes
Assess the proportion of root coverage
Time frame: one month (plus or minus 2 days), Three months (plus or minus 3 days) and six month (plus or minus 5 days)
Clinical attachment level, width of keratinized tissue and the position of the mucogingival junction following root coverage procedures
Time frame: one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
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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.
Sergio I Losada Amaya, Professor principal investigator
Universidad El bosque- UNIECLO
Jaime A Marquez Cristo, Professor study chair
Universidad El Bosque- UNIECLO
Miguel F Vargas del Campo, Professor study chair
Universidad El Bosque- UNIECLO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing coronally partial thickness flap plus connective tissue and coronally mucosal thickness flap in people with Gingival Recession and Periodontal Atrophy, run by Universidad El Bosque, Bogotá at 1 site in Colombia.
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 15 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: status not confirmed, as of the sponsor's last update on 26 Mar 2013. 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 Colombia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Assess percentage of total root coverage between two subepithelial conective tissue graft technique for covering Class I and II Miller recessions patients attending at dental clinics of "Universidad El Bosque" (time frame: one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)). 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 26 Mar 2013; AzTrials last refreshed its copy on 31 Oct 2026.