Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap
Primary Purpose
Gingival Recession, Localized
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CAF
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession, Localized focused on measuring gingival recession, coronally advanced flap, complete root coverage, flap elevation, flap thickness
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Split Full Split Elevation of CAF
Split Elevation of CAF
Arm Description
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
The flap was fully elevated with a split thickness approach: the blade of the knife was inserted into the sulcus
Outcomes
Primary Outcome Measures
CRC
Percentages of recession with a Complete Root Coverage
Secondary Outcome Measures
RC
percentages of Recession Coverage
KTH
Keratinized Tissue Height in mm.
VAS discomfort
patient's discomfort expressed in a 10 cm Visual Analogue Scale, indicating discomfort from 0 (no discomfort) to 10 (maximum discomfort)
VAS esthetic
patient's esthetic expressed in a 10 cm Visual Analogue Scale, indicating esthetic from 0 (worst esthetic) to 10 (optimum esthetic).
VAS satisfaction
patient's satisfaction expressed in a 10 cm. Visual Analogue Scale, indicating satisfaction from 0 (no satisfaction) to 10 (good satisfaction).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03417232
Brief Title
Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap
Official Title
Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap. A Double Blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2013 (Actual)
Primary Completion Date
April 30, 2015 (Actual)
Study Completion Date
April 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Siena
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Localized
Keywords
gingival recession, coronally advanced flap, complete root coverage, flap elevation, flap thickness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Split Full Split Elevation of CAF
Arm Type
Experimental
Arm Description
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
Arm Title
Split Elevation of CAF
Arm Type
Sham Comparator
Arm Description
The flap was fully elevated with a split thickness approach: the blade of the knife was inserted into the sulcus
Intervention Type
Procedure
Intervention Name(s)
CAF
Intervention Description
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.
Primary Outcome Measure Information:
Title
CRC
Description
Percentages of recession with a Complete Root Coverage
Time Frame
12 months
Secondary Outcome Measure Information:
Title
RC
Description
percentages of Recession Coverage
Time Frame
12 months
Title
KTH
Description
Keratinized Tissue Height in mm.
Time Frame
12 months
Title
VAS discomfort
Description
patient's discomfort expressed in a 10 cm Visual Analogue Scale, indicating discomfort from 0 (no discomfort) to 10 (maximum discomfort)
Time Frame
12 months
Title
VAS esthetic
Description
patient's esthetic expressed in a 10 cm Visual Analogue Scale, indicating esthetic from 0 (worst esthetic) to 10 (optimum esthetic).
Time Frame
12 months
Title
VAS satisfaction
Description
patient's satisfaction expressed in a 10 cm. Visual Analogue Scale, indicating satisfaction from 0 (no satisfaction) to 10 (good satisfaction).
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo De Sanctis, MD
Organizational Affiliation
University of Siena
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30099762
Citation
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.
Results Reference
derived
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Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap
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