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

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ClinicalTrials.gov Identifier: NCT02613702
Recruitment Status : Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Universidade Estadual de Maringá
Information provided by (Responsible Party):
Claudio Mendes Pannuti, 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.

Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: Free Gingival Graft Procedure: Original Free Gingival Graft technique Procedure: Modified Free Gingival Graft technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Modified Free Gingival Graft
Twenty 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.
Procedure: Free Gingival Graft
Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.

Procedure: 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

Active Comparator: Original Free Gingival Graft technique
Twenty patients will receive the original technique of free gingival graft at the inferior incisors area.
Procedure: Free Gingival Graft
Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.

Procedure: 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




Primary Outcome Measures :
  1. Apical-cervical width of keratinized tissue after 12 months [ Time Frame: 12 months ]
    Distance between gingival margin and mucogingival junction, in millimeters


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613702


Locations
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Brazil
Faculdade de Odontologia da USP
São Paulo, SP, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo
Universidade Estadual de Maringá
Investigators
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Principal Investigator: Claudio M Pannuti, PhD University of São Paulo
Study Director: João Batista C Neto, PhD University of São Paulo

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Responsible Party: Claudio Mendes Pannuti, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02613702    
Other Study ID Numbers: EFFECT
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Keywords provided by Claudio Mendes Pannuti, University of Sao Paulo:
Free gingival graft
keratinized gingival tissue
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy