Clinical trial NCT02613702: Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial
Official title: Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gingival Recession
Keywords: Free gingival graft
keratinized gingival tissue
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Universidade Estadual de Maringá
First posted: 2015-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The free gingival graft surgery is held to gain some keratinized tissue in areas where it has been lost, such as in inferior incisors with gingival recessions. In these areas, tooth brushing may become harder and painful, negatively influencing in plaque control. However, this type of graft seems to contract over time. A new approach of free gingival graft, in which the graft is covered by a flap, promises to provide greater vascularization. This would promote less graft contraction and better mucosal color. Forty patients with less than 2 mm of keratinized tissue (measured from gingival margin to mucogingival junction) in at least one inferior incisor will be included. Half will receive the original technique and half will receive the modified one. Patients will be followed at 7, 14, 21, 28, 42 days, 3, 6, 12 months and 8 years after surgeries.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Apical-cervical width of keratinized tissue after 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Probing Depth
timeFrame: 12 months
measure: Keratinized tissue area
timeFrame: 12 months
measure: Keratinized tissue thickness
timeFrame: 12 months
measure: Volume of receiving area
timeFrame: 12 months
measure: Complete epithelization of donor area
timeFrame: 28 days
measure: Postoperative discomfort
timeFrame: 28 days
measure: Gum color
timeFrame: 12 months
measure: Oral Health Related Quality of Life (OHIP)
timeFrame: 12 months
measure: Clinical Attachment Level
timeFrame: 12 months
measure: Recession
timeFrame: 12 months
measure: Bleeding on probing
timeFrame: 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Odontologia da USP
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Claudio M Pannuti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: João Batista C Neto, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.