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Completed

NCT Number: NCT02229669

Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions

This study compared the clinical outcomes of coronally advanced flap using two different surgical strategies in the treatment of multiple gingival recessions.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The objective of this split-mouth, randomized controlled trial was to compare the clinical outcomes of coronally advanced flap (CAF) using two different surgical strategies in the treatment of multiple gingival recessions. Recessions were randomly treated according to a split-mouth design by means of: CAF with oblique interdental incisions (OBL technique) or CAF with horizontal interdental incisions (HOR technique). Marginal gingival recession (REC), clinical attachment level (CAL), pocket probing depth (PPD), height of keratinized tissue (HKT) and thickness of keratinized tissue (TKT) were measured at baseline, 3 and 6 months after treatment. Patient-centered outcomes concerning morbidity and improvement in the esthetic appearance were recorded using a Visual Analogue Scale (VAS).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Horizontal incisions

Procedure

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.

Oblique incisions

Procedure

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.

Primary outcomes

  1. Change from baseline in Marginal gingival recession to 6 months

    Time frame: baseline, and at 3 and 6 months post-surgery

Secondary outcomes

  1. height of keratinized tissue

    Time frame: Baseline, 3 and 6 months

  2. thickness of keratinized tissue

    Time frame: baseline, 3 and 6 months

  3. Clinical attachment level

    Time frame: baseline, 3 and 6 months

  4. Probing deph

    Time frame: baseline, 3 and 6 months

Sponsors and collaborators

Lead sponsor

Paulista University

Other

Registry information

Official study title

Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions: A Split-mouth RCT

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Sep 1, 2014
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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