Microsurgical Versus Conventional Semilunar Coronally Advanced Flap
A Clinical Comparison of Microsurgical Versus Conventional Surgical Approaches for the Semilunar Coronally Advanced Flap
1 other identifier
interventional
14
0 countries
N/A
Brief Summary
BACKGROUND: The semilunar coronally repositioned flap (SLCRF) has been used for the treatment of recession defects (GR). Recently a microsusgical (MICRO) has been successfully employed with the procedure apparently resulting in improved results, however, no previous controlled clinical study has evaluated the MICRO SLCRF in comparison with SLCRF performed as originally described (MACRO). The objective of the present study was to compare the clinical outcomes of the MICRO and MACRO SLCRF in the treatment of human GR. METHODS: Fourteen patients, with bilateral Miller class I GR defects were randomly assigned to MICRO or MACRO SLCRF. Clinical parameters, assessed at baseline and 6 months later, included recession height (RECH), recession width (RECW), width of keratinized tissue (WKT), probing depth (PD), clinical attachment level (CAL), pain measurements and esthetic evaluation with the Root Coverage Score (RCS). Inter-measurements differences were analyzed with a Chi-square or a paired t-test, with significance set at α\<0.05.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2010
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
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 8, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedMay 5, 2015
April 1, 2015
1.5 years
January 8, 2015
May 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Root coverage
Distance between the cementum-enamel junction and the gingival margin. Measurements will be performed at baseline (RECH1) and after 6 months (RECH2). The amount of root coverage will be calculated as REC2x100/REC1
6 months
Study Arms (2)
Test - Microsurgical semilunar flap
EXPERIMENTALSemilunar coronally repositioned flap performed under magnification with a surgical microscope. SLI was carried out following the outline of the gingival margin with a microsurgical blade under (8x) magnification. An ISI was performed mid-facially. Then, a split-thickness dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth. A cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap.
Control - Conventional Semilunar flap
ACTIVE COMPARATORSemilunar coronally repositioned flap performed without magnification. A semilunar incision (SLI) was carried out with a 15c surgical blade. An ISI was performed mid-facially. Then, a split-thickness dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth. A cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap.
Interventions
Semilunar coronally repositioned flap performed under magnification with a surgical microscope
Semilunar coronally repositioned flap performed without magnification
8mg Dexamethasone, single dose, 1 hour before surgery
Oral rinses with chlorhexidine gluconate, BID, for 14 days
Regional block
Eligibility Criteria
You may qualify if:
- Presence of bilateral Miller class I gingival recessions (≤ 3mm) exhibiting at least 2mm of keratinized tissue width (WKT) in endodontically-vital maxillary canines or premolars.
- These teeth presented shallow (\<3mm) probing depth (PD) without bleeding on probing. Moreover, the elegible individuals demonstrated absence of contraindications for periodontal surgery, and were not being taking medications known to interfere with periodontal tissue health or healing in the preceding 6 months.
- Experimental teeth were free of caries or restorations in the areas to be treated.
You may not qualify if:
- Patients with untreated periodontal disease, smokers, subjects with immunosuppressive systemic diseases (i.e., cancer, AIDS, diabetes) were not included in the study.
- Miller class II, III or class IV recession defects, presence of apical radiolucency or caries or restorations in the areas to be treated, and previous lack of cooperation with the maintenance program (as evaluated by unjustified absence from scheduled maintenance visits, continued traumatic tooth brushing technique or faulty plaque control measures).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronaldo B Santana, DDS,MScD,DSc
Federal Fluminense University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2015
First Posted
May 5, 2015
Study Start
October 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
May 5, 2015
Record last verified: 2015-04