Clinical trial NCT03616197: The Effect of Different Gingival Biotypes on Dimensional Stability of Free Gingival Graft
Official title: The Effect Of Different Gingival Biotypes On Dimensional Stability Of Free Gingival Graft: A Comparative 6 Month Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Atrophy
Keywords: gingival biotype of adjacent teeth
free gingival graft
shrinkage of graft
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The concept of gingival and periodontal phenotype was established as a result of clinical observation of changes in facial keratinized tissue width and thickness .It has been reported that gingival or periodontal diseases may develop more frequently in patients with thin gingival biotypes and that thick-flat biotype in implant restorations is important in achieving a successful aesthetic treatment outcome.

Free gingival graft (FGG) is a mucogingival surgical procedure that is successfully used in the presence of inadequate keratinized gingival width and gingival recession. It is thought that factors that may adversely affect the continuity of graft nutrition may be effective in graft shrinkage. These reasons can be listed as follows; graft thickness, traumatic surgical procedure, graft dehydration, and suturing procedure.

There was no study investigating the effect of periodontal biotypes on graft contraction in the region adjacent to the FGG operation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The graft shrinkage ratio
timeFrame: baseline - 6th months postoperatively
Secondary outcomes:
measure: keratinized ginigival width
timeFrame: baseline - 6th months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: İstanbul Aydın University, Faculty of Dentistry
name: serap karakış akcan, Phd
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.