NCT03616197

Brief Summary

The aim of this study is to compare the effect of mesial and distal adjacent gingival biotypes of the tooth / teeth region of free gingival graft (FGG) on the shrinkage ratio of graft at 6 months postoperatively.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

July 31, 2018

Last Update Submit

August 7, 2018

Conditions

Keywords

gingival biotype of adjacent teethfree gingival graftshrinkage of graft

Outcome Measures

Primary Outcomes (1)

  • The graft shrinkage ratio

    Graft shrinkage = Preoperative area - Postoperative area X 100 Preoperative area

    baseline - 6th months postoperatively

Secondary Outcomes (1)

  • keratinized ginigival width

    baseline - 6th months postoperatively

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Thin Biotype group has described as Group 1. The biotypes of the terminal teeth adjacent to the free gingival graft region were determined by the "Probe transparency method". The mesial terminal tooth (MTT) was defined as the first tooth adjacent to the mesial side of the tooth / teeth to which the FGG will be applied. The distal terminal tooth (DTT) was defined as the first tooth adjacent to the distal side of the tooth / teeth to which the FGG will be applied. If MTT and DTT had thin biotype, the patient was assigned to the thin biotype group.

Procedure: free gingival graft

Group 2

ACTIVE COMPARATOR

Thick biotype group has described as Group 2. The biotypes of the terminal teeth adjacent to the free gingival graft region were determined by the "Probe transparency method". The mesial terminal tooth (MTT) was defined as the first tooth adjacent to the mesial side of the tooth / teeth to which the FGG will be applied. The distal terminal tooth (DTT) was defined as the first tooth adjacent to the distal side of the tooth / teeth to which the FGG will be applied. If MTT and DTT had thick biotype, the patient was assigned to the thick biotype group.

Procedure: free gingival graft

Interventions

A horizontal incision was made along the mucogingival line with a scalpel number 15 to prepare a bed of periosteum and a thin immobilized connective tissue. The moving gingival tissues were removed coronally, and the bed was prepared so that the immobilized keratinized gingival tissue was preserved and the graft was placed apically. The template of the recipient region was placed in the donor region to be 2-3 mm more apically than the gingival margins of the teeth. The number of 15 scalpel was used to make incision at the template border and perpendicular to the keratinized tissue. The graft thickness was standardized in all patients between 1.5-2 mm. FGG was placed over the recipient bed and 5/0 non-resorbable monofilament sutures were used for fixing the four corners of the graft.

Group 1Group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In the mandibular incisor tooth / teeth, the attached keratinized gingival width is \<1 mm,
  • No periodontal surgery has been performed previously on the involved tooth.
  • In the absence of any systemic condition or illness (pregnancy, breastfeeding, mental retardation, diabetes, etc.) that may interfere with the patient's approval and dental treatment.
  • Do not use any of the drug groups that may cause gingival overgrowth.

You may not qualify if:

  • Previous periodontal surgery in the operation area
  • Restoration of the buccal surface of the tooth and no pathology in the apical region of the tooth.
  • In the presence of any systemic condition or illness (pregnancy, breastfeeding, mental retardation, diabetes, etc.) that may interfere with the patient's approval and dental treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Hatipoglu H, Keceli HG, Guncu GN, Sengun D, Tozum TF. Vertical and horizontal dimensional evaluation of free gingival grafts in the anterior mandible: a case report series. Clin Oral Investig. 2007 Jun;11(2):107-13. doi: 10.1007/s00784-006-0084-x. Epub 2007 Feb 9.

    PMID: 17294229BACKGROUND
  • Gumus P, Buduneli E. Graft stabilization with cyanoacrylate decreases shrinkage of free gingival grafts. Aust Dent J. 2014 Mar;59(1):57-64. doi: 10.1111/adj.12149. Epub 2014 Feb 4.

  • Barbosa FI, Correa DS, Zenobio EG, Costa FO, Shibli JA. Dimensional changes between free gingival grafts fixed with ethyl cyanoacrylate and silk sutures. J Int Acad Periodontol. 2009 Apr;11(2):170-6.

MeSH Terms

Conditions

Gingival RecessionAtrophy

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal AtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • serap karakış akcan, Phd

    İstanbul Aydın University, Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Determination of graft area measurements and shrinkage ratio of all photographs was performed by a periodontologist , an independent specialist who had not performed any surgical procedures.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor doctor

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 6, 2018

Study Start

August 1, 2016

Primary Completion

April 1, 2018

Study Completion

July 1, 2018

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share