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

Not Applicable
Conditions
Gingival Recession
Interventions
Procedure: Free Gingival Graft
Procedure: Original Free Gingival Graft technique
Procedure: Modified Free Gingival Graft technique
Registration Number
NCT02613702
Lead Sponsor
University of Sao Paulo
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 and 12 months after surgeries.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Modified Free Gingival GraftFree Gingival GraftTwenty 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.
Original Free Gingival Graft techniqueFree Gingival GraftTwenty patients will receive the original technique of free gingival graft at the inferior incisors area.
Original Free Gingival Graft techniqueOriginal Free Gingival Graft techniqueTwenty patients will receive the original technique of free gingival graft at the inferior incisors area.
Modified Free Gingival GraftModified Free Gingival Graft techniqueTwenty 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.
Primary Outcome Measures
NameTimeMethod
Apical-cervical width of keratinized tissue after 12 months12 months

Distance between gingival margin and mucogingival junction, in millimeters

Secondary Outcome Measures
NameTimeMethod
Volume of receiving area12 months

Volume of receiving area

Gum color12 months

Measured with photographic analysis

Postoperative discomfort28 days

discomfort measured using Visual Analogue Scale

Keratinized tissue area12 months

Keratinized tissue area, measured in millimeters

Probing Depth12 months

Distance between gingival margin and bottom of the sulcus / pocket, in millimeters

Keratinized tissue thickness12 months

Keratinized tissue thickness measured in millimeters

Complete epithelization of donor area28 days

Area of Epithelization of wound healing, measured in mm2

Oral Health Related Quality of Life (OHIP)12 months

OHIp - 14 short version

Clinical Attachment Level12 months

Distance between cementum-enamel junction and bottom of sulcus / pocket, measured in millimeters

Recession12 months

Distance between cementum-enamel junction and gingival margin, measured in millimeters

Bleeding on probing12 months

percentage of sites which bled upon probing

Trial Locations

Locations (1)

Faculdade de Odontologia da USP

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São Paulo, SP, Brazil

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