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Clinical Evaluation of Single-stage Advanced Versus Rotated Flaps in the Treatment of Gingival Recessions

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ClinicalTrials.gov Identifier: NCT02433912
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
Universidade Federal Fluminense

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.


Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: Test - Laterally positioned flap Procedure: Control-Coronally positioned flap Drug: 750 mg paracetamol Drug: chlorhexidine gluconate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Single-stage Advanced Versus Rotated Flaps in the Treatment of Gingival Recessions:Longitudinal, Controlled Clinical Trial.
Study Start Date : June 2002
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Test - Laterally positioned flap
Incisions 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.
Procedure: Test - Laterally positioned flap
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.

Drug: 750 mg paracetamol
Systemic analgesics consisting of 750 mg of paracetamol was taken every six hours for four days

Drug: chlorhexidine gluconate
chlorhexidine gluconate (2.0%) gel applied in saturated cotton swabs twice a day for 14 days

Active Comparator: Control - Coronally advanced flap
The 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.
Procedure: Control-Coronally positioned flap
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.

Drug: 750 mg paracetamol
Systemic analgesics consisting of 750 mg of paracetamol was taken every six hours for four days

Drug: chlorhexidine gluconate
chlorhexidine gluconate (2.0%) gel applied in saturated cotton swabs twice a day for 14 days




Primary Outcome Measures :
  1. Root coverage [ Time Frame: 5 years ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 defects5, presence of apical radiolucency or caries or restorations in the areas to be treated, and previous lack of cooperation with the maintenance program were also exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433912


Sponsors and Collaborators
Universidade Federal Fluminense
Investigators
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Principal Investigator: Ronaldo B Santana, DDS,MScD,DSc Federal Fluminense University

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Responsible Party: Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT02433912    
Other Study ID Numbers: CEP-HUAP 0129.0.258.000-08
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy
Acetaminophen
Chlorhexidine
Chlorhexidine gluconate
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents