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

Gingival Recession Clinical Trial

— EFFECT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02613702
• Other study ID #: EFFECT
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: November 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Free Gingival Graft
Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.
• Original Free Gingival Graft technique
Surgical technique (autologous graft): Original technique of free gingival graft, positioned at the inferior incisors area at the donor area
• Modified Free Gingival Graft technique
Surgical technique (autologous graft): Free gingival graft. positioned at the inferior incisors area and covered by a flap at the donor area

Locations

Country	Name	City	State
Brazil	Faculdade de Odontologia da USP	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Universidade Estadual de Maringá

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apical-cervical width of keratinized tissue after 12 months	Distance between gingival margin and mucogingival junction, in millimeters	12 months
Secondary	Probing Depth	Distance between gingival margin and bottom of the sulcus / pocket, in millimeters	12 months
Secondary	Keratinized tissue area	Keratinized tissue area, measured in millimeters	12 months
Secondary	Keratinized tissue thickness	Keratinized tissue thickness measured in millimeters	12 months
Secondary	Volume of receiving area	Volume of receiving area	12 months
Secondary	Complete epithelization of donor area	Area of Epithelization of wound healing, measured in mm2	28 days
Secondary	Postoperative discomfort	discomfort measured using Visual Analogue Scale	28 days
Secondary	Gum color	Measured with photographic analysis	12 months
Secondary	Oral Health Related Quality of Life (OHIP)	OHIp - 14 short version	12 months
Secondary	Clinical Attachment Level	Distance between cementum-enamel junction and bottom of sulcus / pocket, measured in millimeters	12 months
Secondary	Recession	Distance between cementum-enamel junction and gingival margin, measured in millimeters	12 months
Secondary	Bleeding on probing	percentage of sites which bled upon probing	12 months