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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02613702
Acronym
EFFECT
Enrollment
40
Registered
2015-11-24
Start date
2015-09-30
Completion date
2025-07-31
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

Keywords

Free gingival graft, keratinized gingival tissue

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.

Interventions

PROCEDUREFree Gingival Graft

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

PROCEDUREOriginal Free Gingival Graft technique

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

PROCEDUREModified 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

Sponsors

Universidade Estadual de Maringá
CollaboratorOTHER
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Apical-cervical width of keratinized tissue after 12 months12 monthsDistance between gingival margin and mucogingival junction, in millimeters

Secondary

MeasureTime frameDescription
Keratinized tissue area12 monthsKeratinized tissue area, measured in millimeters
Keratinized tissue thickness12 monthsKeratinized tissue thickness measured in millimeters
Volume of receiving area12 monthsVolume of receiving area
Complete epithelization of donor area28 daysArea of Epithelization of wound healing, measured in mm2
Postoperative discomfort28 daysdiscomfort measured using Visual Analogue Scale
Probing Depth12 monthsDistance between gingival margin and bottom of the sulcus / pocket, in millimeters
Oral Health Related Quality of Life (OHIP)12 monthsOHIp - 14 short version
Clinical Attachment Level12 monthsDistance between cementum-enamel junction and bottom of sulcus / pocket, measured in millimeters
Recession12 monthsDistance between cementum-enamel junction and gingival margin, measured in millimeters
Bleeding on probing12 monthspercentage of sites which bled upon probing
Gum color12 monthsMeasured with photographic analysis

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026