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Clinical Trials/NCT02613702
NCT02613702
Active, not recruiting
Not Applicable

Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial

University of Sao Paulo1 site in 1 country40 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
University of Sao Paulo
Enrollment
40
Locations
1
Primary Endpoint
Apical-cervical width of keratinized tissue after 12 months
Status
Active, not recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
July 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudio Mendes Pannuti

Associate Professor

University of Sao Paulo

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
  • 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

Outcomes

Primary Outcomes

Apical-cervical width of keratinized tissue after 12 months

Time Frame: 12 months

Distance between gingival margin and mucogingival junction, in millimeters

Secondary Outcomes

  • Postoperative discomfort(28 days)
  • 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)
  • Oral Health Related Quality of Life (OHIP)(12 months)
  • Clinical Attachment Level(12 months)
  • Recession(12 months)
  • Gum color(12 months)
  • Bleeding on probing(12 months)

Study Sites (1)

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