NCT02613702

Brief Summary

This study will compare a new technique of free gingival graft to the original one, in order to evaluate the stability of the graft volume over one year and other variables. Twenty patients will receive the original technique of free gingival graft (controls) and twenty patients will receive the modified technique, in which the free gingival graft is submerged (tests), at the inferior incisors area.

Trial Health

55
Monitor

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 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

9.7 years

First QC Date

November 18, 2015

Last Update Submit

May 20, 2025

Conditions

Gingival Recession

Keywords

Free gingival graftkeratinized gingival tissue

Outcome Measures

Primary Outcomes (1)

  • Apical-cervical width of keratinized tissue after 12 months

    Distance between gingival margin and mucogingival junction, in millimeters

    12 months

Secondary Outcomes (11)

  • Probing Depth

    12 months

  • Keratinized tissue area

    12 months

  • Keratinized tissue thickness

    12 months

  • Volume of receiving area

    12 months

  • Complete epithelization of donor area

    28 days

  • +6 more secondary outcomes

Study Arms (2)

Modified Free Gingival Graft

EXPERIMENTAL

Twenty patients will receive the modified free gingival graft technique at the inferior incisors area. In this technique, the graft is covered by a flap, similarly to what is done in a connective tissue graft surgery.

Procedure: Free Gingival GraftProcedure: Modified Free Gingival Graft technique

Original Free Gingival Graft technique

ACTIVE COMPARATOR

Twenty patients will receive the original technique of free gingival graft at the inferior incisors area.

Procedure: Free Gingival GraftProcedure: Original Free Gingival Graft technique

Interventions

Free Gingival GraftPROCEDURE

Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.

Modified Free Gingival GraftOriginal Free Gingival Graft technique
Original Free Gingival Graft techniquePROCEDURE

Surgical technique (autologous graft): Original technique of free gingival graft, positioned at the inferior incisors area at the donor area

Original Free Gingival Graft technique
Modified Free Gingival Graft techniquePROCEDURE

Surgical technique (autologous graft): Free gingival graft. positioned at the inferior incisors area and covered by a flap at the donor area

Modified Free Gingival Graft

Eligibility Criteria

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

You may qualify if:

  • Reduced keratinized tissue (less than 2 mm) in inferior incisors area
  • Healthy periodontium in inferior incisors area
  • Indication for surgery (e.g. pain during tooth brushing, gingival margin mobility, gingival recession...)
  • Recessions class I, II or III, maximum 3 mm
  • Having signed the informed consent

You may not qualify if:

  • Systemic diseases
  • Smokers
  • Pregnant and lactating women
  • Root caries lesions
  • Previous surgeries at same area
  • Accentuated root abrasion
  • Malpositioning teeth
  • Residual pocket depths greater than 4 mm
  • Tooth mobility greater than 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Odontologia da USP

São Paulo, São Paulo, 05508-000, Brazil

Location

Related Publications (2)

  • Cesar Neto JB, Cavalcanti MC, Silva CO, Almeida VC, Sapata VM, Lazarin RO, Jung R, Romito GA, Tatakis DN, Pannuti CM. Digital three-dimensional assessment of free gingival graft remodeling over 12 months. J Dent. 2024 Sep;148:105216. doi: 10.1016/j.jdent.2024.105216. Epub 2024 Jun 29.

    PMID: 38950768BACKGROUND

  • Almeida VC, Pannuti CM, Ferreira MS, Lazarin RO, Romito GA, Jung RE, Tatakis DN, Silva COE, Cesar Neto JB. Conventional versus flap-protected free gingival graft: a multicenter randomized clinical trial. Braz Oral Res. 2023 Jan 6;37:e001. doi: 10.1590/1807-3107bor-2023.vol37.0001. eCollection 2023.

    PMID: 36629587BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Claudio M Pannuti, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • João Batista C Neto, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 24, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05

Locations

BR(1)