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

Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap. A Double Blind Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession, Localized
• Intervention / Treatment: Procedure: CAF

Detailed Description

Treatment of buccal gingival recession (GR) is the common clinical requirement from patients who are mainly concerned about aesthetics. Noteworthy are also requests linked to root sensitivity, difficulty in oral hygiene procedures, presence of root caries and non-carious cervical lesions. GR defects, when left untreated, do not improve spontaneously and may progress toward increased recession depth (RD) and clinical attachment loss which increase the patient's aesthetic concern and the clinical discomfort due to augmented dental hypersensitivity.

Complete root coverage (CRC) can be considered the primary clinical outcome and selecting the surgical technique depends mainly on the local anatomical characteristics and on the patient's demands.

In patients with a residual amount of keratinized tissue apical to the recession defect, the coronal advanced flap (CAF) may be recommended. This surgical technique results in optimal root coverage, good color blending of the treated area with respect to adjacent soft tissues and a complete recovery of the original (pre-surgical) soft tissue marginal morphology. Furthermore, post-operative morbidity is reduced to a single area of surgical intervention and the overall chair time is limited.

When utilizing CAF technique, critical factors in CRC have been described in the literature. Flap positioning coronal to the CEJ and a tension-free flap design are among the most important ones. Moreover, flap thickness has been shown to influence the clinical outcomes of CAF procedure .

Coronally advanced flap has been widely validated by the literature for the treatment of single recession defects and, currently, different flap designs and technical modifications are available to clinicians.

De Sanctis and Zucchelli have recently introduced the "split-full-split" flap elevation modality. According to the authors, the modulation of flap thickness, produced by the inclusion of periosteum in the central area, increases flap thickness in the portion of the flap residing over the previously exposed avascular root surface. This, in turn, would give better stability to the flap. However, the partial-thickness flap approach is still commonly performed in the clinical practice and it is validated in the literature.

To date, evidence is still lacking on the influence of including the periosteum in the flap when compared with a split thickness approach in obtaining a CRC.

Thus, the aim of this double blind, controlled and randomized clinical trial was to evaluate the possible benefit on wound healing and flap stability of periosteum inclusion comparing a "split-full-split" flap elevation versus a "split" thickness approach when CAF is performed for the treatment of isolated-type gingival recessions in the upper jaw.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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,

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Split Full Split Elevation of CAF; 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; 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.
SHAM_COMPARATOR: Split Elevation of CAF; The flap was fully elevated with a split thickness approach: the blade of the knife was inserted into the sulcus	Procedure: CAF; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRC	Percentages of recession with a Complete Root Coverage	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RC	percentages of Recession Coverage	12 months
KTH	Keratinized Tissue Height in mm.	12 months
VAS discomfort	patient's discomfort expressed in a 10 cm Visual Analogue Scale, indicating discomfort from 0 (no discomfort) to 10 (maximum discomfort)	12 months
VAS esthetic	patient's esthetic expressed in a 10 cm Visual Analogue Scale, indicating esthetic from 0 (worst esthetic) to 10 (optimum esthetic).	12 months
VAS satisfaction	patient's satisfaction expressed in a 10 cm. Visual Analogue Scale, indicating satisfaction from 0 (no satisfaction) to 10 (good satisfaction).	12 months

Collaborators and Investigators

• Sponsor: University of Siena
• Investigators: Principal Investigator: Massimo De Sanctis, MD, University of Siena

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2013
• Primary Completion (ACTUAL): April 30, 2015
• Study Completion (ACTUAL): April 30, 2015

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (ACTUAL): January 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: gingival recession; coronally advanced flap; complete root coverage; flap elevation; flap thickness
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: CAF0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No