Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions
1 other identifier
interventional
10
0 countries
N/A
Brief Summary
This study compared the clinical outcomes of coronally advanced flap using two different surgical strategies in the treatment of multiple gingival recessions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2011
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 21, 2014
CompletedFirst Posted
Study publicly available on registry
September 1, 2014
CompletedSeptember 1, 2014
August 1, 2014
1.4 years
August 21, 2014
August 28, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Marginal gingival recession to 6 months
baseline, and at 3 and 6 months post-surgery
Secondary Outcomes (4)
height of keratinized tissue
Baseline, 3 and 6 months
thickness of keratinized tissue
baseline, 3 and 6 months
Clinical attachment level
baseline, 3 and 6 months
Probing deph
baseline, 3 and 6 months
Study Arms (2)
Horizontal incisions
EXPERIMENTALCoronally 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.
Oblique incisions
EXPERIMENTALCoronally 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzana Pimentel, PHD
Paulista University
- STUDY CHAIR
Guilherme Barrella, MS
Paulista University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MS, DDS
Study Record Dates
First Submitted
August 21, 2014
First Posted
September 1, 2014
Study Start
March 1, 2011
Primary Completion
August 1, 2012
Study Completion
July 1, 2013
Last Updated
September 1, 2014
Record last verified: 2014-08