The Effect of Different Gingival Biotypes on Dimensional Stability of Free Gingival Graft
The Effect Of Different Gingival Biotypes On Dimensional Stability Of Free Gingival Graft: A Comparative 6 Month Clinical Study
1 other identifier
interventional
30
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2016
Typical duration for not_applicable
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 31, 2018
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedAugust 9, 2018
August 1, 2018
1.7 years
July 31, 2018
August 7, 2018
Conditions
Keywords
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 COMPARATORThin 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.
Group 2
ACTIVE COMPARATORThick 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.
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.
Eligibility Criteria
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: 17294229BACKGROUNDGumus 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.
PMID: 24494804RESULTBarbosa 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.
PMID: 19431956RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
serap karakış akcan, Phd
İstanbul Aydın University, Faculty of Dentistry
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