NCT05472233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 21, 2022

Last Update Submit

July 20, 2025

Conditions

Gingival Recession

Keywords

Gingival recessionSuturesRoot coverageHealing

Outcome Measures

Primary Outcomes (2)

  • Complete Root Coverage

    Achievement of 100% root coverage, measured as yes / no

    6 months

  • Mean Root Coverage

    Percentage of the root recession that has been successfully covered after the surgical procedure

    6 months

Secondary Outcomes (1)

  • Patient discomfort

    at suture removal

Study Arms (2)

2weeks

ACTIVE COMPARATOR

Suture removal at 2 weeks post intervention

Procedure: Suture removal after Coronally Positioned Flap

3+weeks

EXPERIMENTAL

Suture removal at 3 weeks minimum post intervention

Procedure: Suture removal after Coronally Positioned Flap

Interventions

Suture removal after Coronally Positioned FlapPROCEDURE

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.

2weeks3+weeks

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Adjacent recessions
  • Recessions on molar teeth
  • Coronally advanced flaps without releasing incisions
  • Patients with active periodontitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Duilio Casula, AOU Cagliari

Monserrato, CA, 09042, Italy

Location

Related Publications (6)

  • 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.

    PMID: 26447751BACKGROUND

  • 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.

    PMID: 30151706BACKGROUND

  • Huang LH, Wang HL. Sling and tag suturing technique for coronally advanced flap. Int J Periodontics Restorative Dent. 2007 Aug;27(4):379-85.

    PMID: 17726994BACKGROUND

  • 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.

    PMID: 16253095BACKGROUND

  • 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.

    PMID: 25315018BACKGROUND

  • 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.

    PMID: 21859324BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Retrospective cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 25, 2022

Study Start

September 1, 2022

Primary Completion

November 30, 2022

Study Completion

March 31, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Individual participant data will be shared in a publication after the end of the study

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data will be submitted for publication right after the analysis of the outcomes

Locations

IT(1)