- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03616197
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Group 1
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. |
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.
|
|
ACTIVE_COMPARATOR: Group 2
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The graft shrinkage ratio
Time Frame: baseline - 6th months postoperatively
|
Graft shrinkage = Preoperative area - Postoperative area X 100 Preoperative area
|
baseline - 6th months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
keratinized ginigival width
Time Frame: baseline - 6th months postoperatively
|
Keratinized Gingival Width(KGW) was measured using a lugol solution (10% potassium iodide and 5% iodine) with a manual caliper spaced 0.5 mm from the mid-buccal point of the tooth, the distance between the gingival margin and mucogingival junction from MTT, DTT and the teeth/tooth in operation area.
|
baseline - 6th months postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: serap karakış akcan, Phd, Istanbul Aydın University, Faculty of Dentistry
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-9/7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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