NCT05563428

Brief Summary

This study wil compare FGG and CTG for recession coverage in the anterior mandibula.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

1.9 years

First QC Date

September 21, 2022

Last Update Submit

September 28, 2022

Conditions

Gingival RecessionGingival Recession, Localized

Keywords

Gingival recessionFree gingival graftConnective tissue graft

Outcome Measures

Primary Outcomes (1)

  • Digital mean root coverage

    Defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a reference. Measured by dividing the mean surface (in mm²) of the root covered by the procedure by the mean surface (in mm²) of root exposed at baseline.

    Baseline, 3 months, 6 months and up to 10 years after surgery

Other Outcomes (14)

  • Complete root coverage

    Baseline, 3 months, 6 months and up to 10 years after surgery

  • Mean root coverage

    Baseline, 3 months, 6 months and up to 10 years after surgery

  • Keratinized tissue height

    Baseline, 3 months, 6 months and up to 10 years after surgery

  • +11 more other outcomes

Study Arms (2)

Free gingival graft

ACTIVE COMPARATOR

Free gingival graft will be conducted.

Procedure: Free gingival graft

Connective tissue graft

ACTIVE COMPARATOR

The recession will be treated with the pouch technique using a connective tissue graft.

Procedure: Connective tissue graft

Interventions

Free gingival graftPROCEDURE

A free gingival graft will be carried out for recession treatment.

Free gingival graft
Connective tissue graftPROCEDURE

The pouch technique with a connective tissue graft will be carried out for recession treatment.

Connective tissue graft

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA type I and II subjects
  • Localized Gingival Recessions
  • Recessions Cairo RT I-II-III
  • FMPS \< 10%
  • FMBS\< 10%
  • \<10 cigs/ day
  • No contra-indication against oral surgical interventions
  • Patient is able to give inform consent

You may not qualify if:

  • Infection (local or systemic). Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to entering the study. In case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
  • ASA type \> II
  • Current pregnancy or breastfeeding women
  • Alcoholism or chronically drug abuse
  • Smokers, ≳ 10 cigarettes per day
  • Immunocompromised patients
  • Uncontrolled diabetes
  • Untreated periodontitis
  • History of previous periodontal surgery (mucogingival or other) on the teeth to be included
  • Presence of severe tooth malposition, rotation or significant version of the tooth to be treated
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Szoted Gilles, MSc

    ULiège

    PRINCIPAL INVESTIGATOR

Central Study Contacts

France Lambert, PhD

CONTACT

+32 4 270 31 05france.lambert@chuliege.be

Isabelle Laleman, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chef de clinique

Study Record Dates

First Submitted

September 21, 2022

First Posted

October 3, 2022

Study Start

September 1, 2021

Primary Completion

July 31, 2023

Study Completion

December 31, 2023

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

BE(1)