Clinical trial NCT06749119: The Effects of Age on Wound Healing on Free Gingival Graft Surgery in the Treatment of Attached Keratinized Gingival Deficiency by Determining Clinical and Biochemical Outcomes
Official title: Effect of Age on Recipient Site Wound Healing in Free Gingival Graft Operation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Wound Healing
Tissue Grafts
Age
Vegf
TGF-β
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to assess the effects of age on wound healing on free gingival graft (FGG) surgery in the treatment of attached keratinized gingival deficiency by determining clinical and biochemical outcomes.

Detailed description: Aim of this study was to evaluate the effect of age on clinical and biochemical healing outcomes on FGG surgery in the treatment of attached keratinized gingival deficiency (≤2 mm) at mandibular anterior region. A total of 30 systemically healthy patients, divided into two groups and planned for FGG operations, were included in this study. These groups are; Group l : 15 patients in the age range of 20-35, group 2: 15 patients in the age range of 50-65. Gingival crevicular fluid and wound fluid samples were taken from these patients to analyze VEGF, EGF and TGF-B1 levels by ELISA. Wound fluid samples were taken baseline, 4,7, and 14 days after surgery.

Clinical parameters included measurement of probing depth (PD), clinical attachment level (CAL), bleeding of probing (BOP), plaque index (PI), gingival index (GI) at 6 sites per tooth except the third molars were measured at baseline and l, 3 and 6 months after surgery. Keratinized gingiva width, keratinized gingiva thickness of the operation sites were measured baseline and 1,3 and 6 months after surgery. Vertical dimension of the graft, horizontal dimension of the graft, graft thickness were measured at baseline and 1,3,6 months after surgery. Graft area measurements were calculated on standard photographs by a Java-based analysis program (ImageJ, National Institutes of Health, Bethesda, MD) to determine the shrinkage rate of the grafts. The graft shrinkage ratio was calculated as the difference between baseline to 1-month, baseline to 3-months, baseline to 6-month graft site value. Data were analyzed using appropriate statistical tests.

Eligibility criteria: Inclusion Criteria:

* having ≤2mm of keratinized gingiva in at least 1 mandibular anterior tooth
* periodontally healthy with full-mouth bleeding and plaque score ≤ 10%
* no use of any drugs that will affect periodontal tissue health and healing process
* absence of any systemic condition or illness

Exclusion Criteria:

* smokers
* previous periodontal surgery
* a pathology in the apical region of the tooth
* pregnancy, lactation

Primary outcomes:
measure: Shrinkage percentage (%)
timeFrame: from baseline to 1-,3-,6- months
Secondary outcomes:
measure: VEGF levels (pg/ml)
timeFrame: from baseline to 1-,3-,6- months
measure: EGF levels (pg/ml)
timeFrame: baseline to 1-,3-,6- months
measure: TGFβ-1 levels (pg/ml)
timeFrame: from baseline to 1-,3-,6- months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Dentistry
state: Maltepe
Study officials:
References: