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NCT Number: NCT02613702

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade de Odontologia da USP

São Paulo, 05508-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Free gingival graft

Procedure

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

Original Free Gingival Graft technique

Procedure

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

Procedure

Surgical technique (autologous graft): Free gingival graft. positioned at the inferior incisors area and covered by a flap at the donor area

Primary outcomes

  1. Apical-cervical width of keratinized tissue after 12 months

    Time frame: 12 months

    Distance between gingival margin and mucogingival junction, in millimeters

Secondary outcomes

  1. Probing Depth

    Time frame: 12 months

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

  2. Keratinized tissue area

    Time frame: 12 months

    Keratinized tissue area, measured in millimeters

  3. Keratinized tissue thickness

    Time frame: 12 months

    Keratinized tissue thickness measured in millimeters

  4. Volume of receiving area

    Time frame: 12 months

    Volume of receiving area

  5. Complete epithelization of donor area

    Time frame: 28 days

    Area of Epithelization of wound healing, measured in mm2

  6. Postoperative discomfort

    Time frame: 28 days

    discomfort measured using Visual Analogue Scale

  7. Gum color

    Time frame: 12 months

    Measured with photographic analysis

  8. Oral Health Related Quality of Life (OHIP)

    Time frame: 12 months

    OHIp - 14 short version

  9. Clinical Attachment Level

    Time frame: 12 months

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

  10. Recession

    Time frame: 12 months

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

  11. Bleeding on probing

    Time frame: 12 months

    percentage of sites which bled upon probing

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Universidade Estadual de Maringá

Registry information

Acronym: EFFECT

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2015
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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