Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap

NCT03417232 | Completed

• 1 other identifier: CAF0001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: to evaluate the possible benefit on wound healing and flap stability of periosteum inclusion, comparing a "split-full-split" thickness flap elevation versus a "split" thickness approach performed during CAF for the treatment of isolated-type gingival recessions in the upper jaw. Material and Methods: forty patients were randomized, 20 were treated with "split-full-split" (test group) and 20 with a "split" approach (control group). Analyzed parameters at 1 year were: CRC, percentage of Recession Coverage (RC), Keratinized tissue (KT) gain, patient-related outcome measurements.

Conditions

Gingival Recession, Localized

Keywords

gingival recession; coronally advanced flap; complete root coverage; flap elevation; flap thickness

Outcome Measures

Primary Outcomes (1)

• CRC

  Percentages of recession with a Complete Root Coverage

  12 months

Secondary Outcomes (5)

• RC

  12 months

• KTH

  12 months

• VAS discomfort

  12 months

• VAS esthetic

  12 months

• VAS satisfaction

  12 months

Study Arms (2)

Split Full Split Elevation of CAF

EXPERIMENTAL

The central portion of the flap apical to the recession was elevated full thickness by the use of a small periostium elevator inserted into the probable sulcus

Procedure: CAF

Split Elevation of CAF

SHAM COMPARATOR

The flap was fully elevated with a split thickness approach: the blade of the knife was inserted into the sulcus

Procedure: CAF

Interventions

CAF PROCEDURE

The design of the flap consisted of two horizontal beveled incisions (3mm in length) and two slightly oblique beveled incisions. The resulting trapezoidal-shaped flap was elevated in the coronal-apical direction. The suture of the flap started with two interrupted periosteal sutures performed at the most apical extension of the vertical releasing incisions; afterwards, it proceeded coronally with other interrupted sutures, each of them directed, from the flap to the adjacent buccal soft tissue, in the apical-coronal direction. The last sling suture allowed for the stabilization of the surgical papillae over the inter-dental connective tissue bed and allowed for a precise adaptation of the flap margin over the underlying convexity of the crown.

Split Elevation of CAF; Split Full Split Elevation of CAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 years,
• no systemic diseases or pregnancy,
• smoking ≤10 cigarettes/day,
• full-mouth plaque score and full-mouth bleeding score ≤20%,
• presence of at least one Miller class I or II isolated recession defect (Miller, 1985) in the upper jaw and at least 2 mm of keratinized tissue apical to the recession,
• recession depth (RD) equal to or greater than 2mm,
• identifiable cemento-enamel junction (CEJ),
• vital teeth, free from caries or prosthetic crown,

You may not qualify if:

• systemic diseases or pregnancy,
• history of periodontal surgery at experimental sites.

Sponsors & Collaborators

• University of Siena: lead

Related Publications (1)

• Clementini M, Discepoli N, Danesi C, de Sanctis M. Biologically guided flap stability: the role of flap thickness including periosteum retention on the performance of the coronally advanced flap-A double-blind randomized clinical trial. J Clin Periodontol. 2018 Oct;45(10):1238-1246. doi: 10.1111/jcpe.12998. Epub 2018 Sep 14.

  PMID: 30099762 DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Massimo De Sanctis, MD

  University of Siena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 31, 2018
• Study Start: April 1, 2013
• Primary Completion: April 30, 2015
• Study Completion: April 30, 2015
• Last Updated: February 1, 2018

Record last verified: 2018-01