NCT02229669

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Status
completed

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

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

August 21, 2014

Last Update Submit

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

EXPERIMENTAL

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.

Procedure: Horizontal incisionsProcedure: Oblique incisions

Oblique incisions

EXPERIMENTAL

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.

Procedure: Horizontal incisionsProcedure: Oblique incisions

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.

Horizontal incisionsOblique incisions

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.

Horizontal incisionsOblique incisions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Suzana Pimentel, PHD

    Paulista University

    PRINCIPAL INVESTIGATOR
  • Guilherme Barrella, MS

    Paulista University

    STUDY CHAIR

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