- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02229669
Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions
August 28, 2014 updated by: Guilherme Barrella, Paulista University
Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions: A Split-mouth RCT
This study compared the clinical outcomes of coronally advanced flap using two different surgical strategies in the treatment of multiple gingival recessions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective of this split-mouth, randomized controlled trial was to compare the clinical outcomes of coronally advanced flap (CAF) using two different surgical strategies in the treatment of multiple gingival recessions.
Recessions were randomly treated according to a split-mouth design by means of: CAF with oblique interdental incisions (OBL technique) or CAF with horizontal interdental incisions (HOR technique).
Marginal gingival recession (REC), clinical attachment level (CAL), pocket probing depth (PPD), height of keratinized tissue (HKT) and thickness of keratinized tissue (TKT) were measured at baseline, 3 and 6 months after treatment.
Patient-centered outcomes concerning morbidity and improvement in the esthetic appearance were recorded using a Visual Analogue Scale (VAS).
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Systemically healthy subjects
- Patients should have bilateral Class I and II MGRs (Miller 1985) in maxillary tooth (at least three recession-type defects affecting adjacent teeth in each side of the maxilla).
- At least 20 teeth and no sites with attachment loss and probing pocket depth (PPD) > 3 mm.
- Full-mouth plaque and bleeding on probing of < 20%.
- Involved tooth should present tooth vitality, absence of caries, restorations or extensive non-carious cervical lesion.
Exclusion Criteria:
- History of smoking.
- Antimicrobial and anti-inflammatory therapies in the previous 2 months.
- Previous mucogingival surgery at the region to be treated
- Systemic conditions that could affect tissue healing (e.g. diabetes).
- Use of orthodontic appliances.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Horizontal incisions
Coronally advanced flap was performed by using horizontal interdental incisions.
An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions.
A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically.
A sulcular incision was made to link the second incisions and the blade was inserted extending beyond the mucogingival junction, to create a uniform split-thickness flap.
The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure.
Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed.
|
Performed by using horizontal interdental incisions.
An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions.
A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically.
A sulcular incision was made to link the second incisions and the blade was inserted (2 to 3 mm) extending beyond the mucogingival junction (MGJ), to create a uniform split-thickness flap.
The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure.
Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed.
Passive closure of the wound margins without tension was achieved with interrupted coaptation.
Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli & De Sanctis (2000).
Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction.
During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions.
Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed.
|
Experimental: Oblique incisions
Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli & De Sanctis (2000).
Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction.
During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions.
Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed.
|
Performed by using horizontal interdental incisions.
An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions.
A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically.
A sulcular incision was made to link the second incisions and the blade was inserted (2 to 3 mm) extending beyond the mucogingival junction (MGJ), to create a uniform split-thickness flap.
The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure.
Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed.
Passive closure of the wound margins without tension was achieved with interrupted coaptation.
Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli & De Sanctis (2000).
Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction.
During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions.
Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in Marginal gingival recession to 6 months
Time Frame: baseline, and at 3 and 6 months post-surgery
|
baseline, and at 3 and 6 months post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
height of keratinized tissue
Time Frame: Baseline, 3 and 6 months
|
Baseline, 3 and 6 months
|
thickness of keratinized tissue
Time Frame: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Clinical attachment level
Time Frame: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Probing deph
Time Frame: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suzana Pimentel, PHD, Paulista University
- Study Chair: Guilherme Barrella, MS, Paulista University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
August 21, 2014
First Submitted That Met QC Criteria
August 28, 2014
First Posted (Estimate)
September 1, 2014
Study Record Updates
Last Update Posted (Estimate)
September 1, 2014
Last Update Submitted That Met QC Criteria
August 28, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1158-9611
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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