Back to resultsCoronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions
Primary Purpose
Gingival Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Horizontal incisions
Oblique incisions
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Diseases
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Horizontal incisions
Oblique incisions
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline in Marginal gingival recession to 6 months
Secondary Outcome Measures
height of keratinized tissue
thickness of keratinized tissue
Clinical attachment level
Probing deph
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02229669
Brief Title
Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions
Official Title
Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions: A Split-mouth RCT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Paulista University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study compared the clinical outcomes of coronally advanced flap using two different surgical strategies in the treatment of multiple gingival recessions.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Horizontal incisions
Arm Type
Experimental
Arm Description
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.
Arm Title
Oblique incisions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Horizontal incisions
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Oblique incisions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Marginal gingival recession to 6 months
Time Frame
baseline, and at 3 and 6 months post-surgery
Secondary Outcome Measure Information:
Title
height of keratinized tissue
Time Frame
Baseline, 3 and 6 months
Title
thickness of keratinized tissue
Time Frame
baseline, 3 and 6 months
Title
Clinical attachment level
Time Frame
baseline, 3 and 6 months
Title
Probing deph
Time Frame
baseline, 3 and 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzana Pimentel, PHD
Organizational Affiliation
Paulista University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guilherme Barrella, MS
Organizational Affiliation
Paulista University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions
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