Effect of Suturing Protocols on Coronally Advanced Flap for Root Coverage Outcomes
Primary Purpose
Gingival Recession
Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Suture removal after Coronally Positioned Flap
Sponsored by
About this trial
This is an interventional prevention trial for Gingival Recession focused on measuring Gingival recession, Sutures, Root coverage, Healing
Eligibility Criteria
Inclusion Criteria:
- Patients not affected by active periodontitis
- Single recessions on non-restored non-molar teeth
- CAF protocols using vertical releasing incisions
- records of patients clearly reporting timing of suture removals and root coverage outcomes at 6 months
Exclusion Criteria:
- Adjacent recessions
- Recessions on molar teeth
- Coronally advanced flaps without releasing incisions
- Patients with active periodontitis
Sites / Locations
- Policlinico Duilio Casula, AOU Cagliari
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
2weeks
3+weeks
Arm Description
Suture removal at 2 weeks post intervention
Suture removal at 3 weeks minimum post intervention
Outcomes
Primary Outcome Measures
Complete Root Coverage
Achievement of 100% root coverage, measured as yes / no
Mean Root Coverage
Percentage of the root recession that has been successfully covered after the surgical procedure
Secondary Outcome Measures
Patient discomfort
Discomfort reported by the patient (present/absent)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05472233
Brief Title
Effect of Suturing Protocols on Coronally Advanced Flap for Root Coverage Outcomes
Official Title
The Effect of Sutures Removal Protocols on Coronally Advanced Flap for Root Coverage Outcomes: a Retrospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this retrospective study is to investigate whether suturing protocols (suture removal timing) influence root coverage outcomes in recession defects treated with a coronally advanced flap (CAF) procedure.
Detailed Description
The aim of this study is to assess whether the timing of suture removal may influence the number of sites exhibiting complete coverage (CRC) or the mean root coverage (MRC) obtained in single-tooth recession-type defects treated by coronally advanced flap (CAF).
Records from patients that underwent a coronally advanced flap (CAF) procedure for root coverage will be analyzed. This surgical procedure is aimed at the treatment of root recessions that may arise following periodontal disease or mechanical trauma. The procedure, after obtaining deep local anesthesia, involves a sulcular incision on the buccal side and extending the incision mesially and distally to the base of the adjacent papillae. Two vertical incisions are then made at the corner of the adjacent tooth line and extended into the alveolar mucosa. A mixed thickness flap is then elevated and coronally advanced by releasing incisions through the periosteum to allow for flap placement to cover the recession without tension. The papillae are de-epithelized to provide the bed of connective tissue for the adaptation of the flap which is then sutured with single stitches.
The records, complete with photographic documentation, of all patients who have undergone this procedure will be identified and will be divided into two groups: those in which the sutures were removed at 2 weeks and those in which the sutures were removed at 3 or more weeks.
CRC as present or absent (yes/no) and MRC (percentage of roof surface that has been successfully covered) six months after surgery will be assessed in these patients.
The presence of patient discomfort on the day of suture removal will be recorded as present / absent to assess whether the permanence of the sutures for longer or shorter influences the patient's perception of the surgery.
The results will be compared between the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Gingival recession, Sutures, Root coverage, Healing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Retrospective cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2weeks
Arm Type
Active Comparator
Arm Description
Suture removal at 2 weeks post intervention
Arm Title
3+weeks
Arm Type
Experimental
Arm Description
Suture removal at 3 weeks minimum post intervention
Intervention Type
Procedure
Intervention Name(s)
Suture removal after Coronally Positioned Flap
Intervention Description
Sutures are removed after different healing period post coronally positioned flap surgery, this latter is a procedure that aims at surgically advancing the gingiva in order to cover dehiscences of the soft tissues uncovering dental roots.
Primary Outcome Measure Information:
Title
Complete Root Coverage
Description
Achievement of 100% root coverage, measured as yes / no
Time Frame
6 months
Title
Mean Root Coverage
Description
Percentage of the root recession that has been successfully covered after the surgical procedure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient discomfort
Description
Discomfort reported by the patient (present/absent)
Time Frame
at suture removal
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients not affected by active periodontitis
Single recessions on non-restored non-molar teeth
CAF protocols using vertical releasing incisions
records of patients clearly reporting timing of suture removals and root coverage outcomes at 6 months
Exclusion Criteria:
Adjacent recessions
Recessions on molar teeth
Coronally advanced flaps without releasing incisions
Patients with active periodontitis
Facility Information:
Facility Name
Policlinico Duilio Casula, AOU Cagliari
City
Monserrato
State/Province
CA
ZIP/Postal Code
09042
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Alberto Valente, DDS, MS, PHD
Email
navalentedds@gmail.com
First Name & Middle Initial & Last Name & Degree
Nicola Alberto Valente, DDS, MS, PHD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be shared in a publication after the end of the study
IPD Sharing Time Frame
Data will be submitted for publication right after the analysis of the outcomes
Citations:
PubMed Identifier
26447751
Citation
Tatakis DN, Chambrone L. The Effect of Suturing Protocols on Coronally Advanced Flap Root-Coverage Outcomes: A Meta-Analysis. J Periodontol. 2016 Feb;87(2):148-55. doi: 10.1902/jop.2015.150394. Epub 2015 Oct 8.
Results Reference
background
PubMed Identifier
30151706
Citation
Tavelli L, Barootchi S, Ravida A, Suarez-Lopez Del Amo F, Rasperini G, Wang HL. Influence of suturing technique on marginal flap stability following coronally advanced flap: a cadaver study. Clin Oral Investig. 2019 Apr;23(4):1641-1651. doi: 10.1007/s00784-018-2597-5. Epub 2018 Aug 27.
Results Reference
background
PubMed Identifier
17726994
Citation
Huang LH, Wang HL. Sling and tag suturing technique for coronally advanced flap. Int J Periodontics Restorative Dent. 2007 Aug;27(4):379-85.
Results Reference
background
PubMed Identifier
16253095
Citation
Huang LH, Neiva RE, Wang HL. Factors affecting the outcomes of coronally advanced flap root coverage procedure. J Periodontol. 2005 Oct;76(10):1729-34. doi: 10.1902/jop.2005.76.10.1729.
Results Reference
background
PubMed Identifier
25315018
Citation
Tatakis DN, Chambrone L, Allen EP, Langer B, McGuire MK, Richardson CR, Zabalegui I, Zadeh HH. Periodontal soft tissue root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S52-5. doi: 10.1902/jop.2015.140376. Epub 2014 Oct 15.
Results Reference
background
PubMed Identifier
21859324
Citation
Chambrone L, Pannuti CM, Tu YK, Chambrone LA. Evidence-based periodontal plastic surgery. II. An individual data meta-analysis for evaluating factors in achieving complete root coverage. J Periodontol. 2012 Apr;83(4):477-90. doi: 10.1902/jop.2011.110382. Epub 2011 Aug 22.
Results Reference
background
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Effect of Suturing Protocols on Coronally Advanced Flap for Root Coverage Outcomes
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