Clinical Evaluation of Single-stage Advanced Versus Rotated Flaps in the Treatment of Gingival Recessions
1 other identifier
interventional
36
0 countries
N/A
Brief Summary
BACKGROUND: Several procedures have been reported for the surgical correction of gingival recession (GR), including the laterally positioned flap (LPF) and the coronally advanced flap (CAF), performed as single or two-stage procedures without or with, respectively, the preceding placement and healing of a free gingival graft (FGG). The objective of the present report was to compare the efficacy of single-stage LPF and CAF techniques in the treatment of localized maxillary GR defects. METHODS: Thirty-six patients with Miller class I GR defects were randomly assigned to be treated by either a CAF (n=18) or LPF (n=18). Clinical parameters, including recession height (RECH), the width of keratinized tissue (WKT), probing depth (PD) and vertical clinical attachment level (VAL) were assessed at the mid-buccal site. Visual plaque score (VPS) and bleeding on probing (BOP) were also assessed dichotomously. Clinical recordings were performed at baseline, 6 months and 5 years later. Inter-measurements differences were analyzed with a Chi-square or a Wilcoxon 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 Jun 2002
Longer than P75 for phase_4
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
June 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
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
9.5 years
January 8, 2015
May 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Root coverage
Root coverage will be measured as the reduction in recession height (RECH). RECH will be measured at baseline RECH1 and after 5 years RECH5. The amount of of root coverage will be measured as REC5x100/REC1.
5 years
Study Arms (2)
Test - Laterally positioned flap
EXPERIMENTALIncisions were made in mesial and distal aspects of the recession, in order to remove the epithelial attachment. The root surface was then instrumented. The flap design was outlined by two vertical incisions which extended from the horizontal incision which was performed either at the gingival, or 1 - 2mm apically, following the marginal gingival contour. The flap was rotated laterally in order to completely cover the recession defect and extend for approximatelly 1mm coronal to the CEJ. Careful flap suturing was performed in order to position and secure the soft tissues over the root surface by means of sling and simple sutures.
Control - Coronally advanced flap
ACTIVE COMPARATORThe CAF was designed performing two vertical releasing incisions at both the mesial and distal aspects of the recession to be treated, in such a way that both the proximal papillae were not included as part of the flap. The vertical incisions were joined by an intrasulcular incision. A combined mucoperiosteal-mucosal flap was elevated. Thorough root planning was performed. A complementary horizontal incision was performed on the apical aspect of the flap, releasing it from the attached periosteum. This allowed the elongation and free coronal positioning of the flap. The flap was coronally positioned and maintained in place by means of individual 5.0 monofilament sutures.
Interventions
Laterally positioned flap. Systemic analgesics consisting of 750 mg of paracetamol was taken every six hours for four days. chlorhexidine gluconate (2.0%) gel applied in saturated cotton swabs twice a day for 14 days.
Coronally positioned flap. Systemic analgesics consisting of 750 mg of paracetamol was taken every six hours for four days. chlorhexidine gluconate (2.0%) gel applied in saturated cotton swabs twice a day for 14 days.
Systemic analgesics consisting of 750 mg of paracetamol was taken every six hours for four days
chlorhexidine gluconate (2.0%) gel applied in saturated cotton swabs twice a day for 14 days
Eligibility Criteria
You may qualify if:
- Adult patients with no contraindications for periodontal surgery, and who had not taken medications known to interfere with periodontal tissue health or healing in the preceding 6 months, exhibiting the presence of Miller class I gingival recessions5 in maxillary incisors, canines or premolars, probing depth (PD) \<3mm without bleeding on probing, presenting tooth vitality and absence 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.
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
- DOUBLE
- Who Masked
- PARTICIPANT, 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
June 1, 2002
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
May 5, 2015
Record last verified: 2015-04