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

Effect of Age on Recipient Site Wound Healing in Free Gingival Graft Operation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Wound Healing; Age; TGF-β; Tissue Grafts; Vegf
• Intervention / Treatment: Procedure: Free gingival graft operation

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Maltepe
    • Istanbul, Maltepe, Turkey, 34854
      • Marmara University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Young group: Aged 20-35 years; They received free gingival operation. Graft was harvested from palatal region and placed to the recipient site. Wound fluid samples were collected from 4 regions of the wound at baseline, 4-,7-,14-days. Clinical measurements were done at baseline, 1-,3-,6-months postoperatively.	Procedure: Free gingival graft operation; Free gingival graft was harvested from palatal region and stabilized on the maxillary anterior recipient bed with sutures .
Active Comparator: Adult group: Aged 50-65 years; They received free gingival operation. Graft was harvested from palatal region and placed to the recipient site. Wound fluid samples were collected from 4 regions of the wound at baseline, 4-,7-,14-days. Clinical measurements were done at baseline, 1-,3-,6-months postoperatively.	Procedure: Free gingival graft operation; Free gingival graft was harvested from palatal region and stabilized on the maxillary anterior recipient bed with sutures .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shrinkage percentage (%)	Shrinkage percentage of the graft area due to the changes in graft dimensions	from baseline to 1-,3-,6- months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VEGF levels (pg/ml)	change in wound fluid VEGF levels from baseline to 1-,3-,6- months after surgery	from baseline to 1-,3-,6- months
EGF levels (pg/ml)	change in wound fluid EGF levels from baseline to 1-,3-,6- months after surgery	baseline to 1-,3-,6- months
TGFβ-1 levels (pg/ml)	change in wound fluid TGFβ-1 levels from baseline to 1-,3-,6- months after surgery	from baseline to 1-,3-,6- months

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2023
• Primary Completion (Estimated): December 27, 2024
• Study Completion (Estimated): December 27, 2024

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 09.2020.660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No