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Clinical Trials/NCT06749119
NCT06749119Active, not recruitingNot Applicable

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

Marmara University1 site in 1 country30 target enrollmentStarted: April 14, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
30
Locations
1
Primary Endpoint
Shrinkage percentage (%)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

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

Arms & Interventions

Young group: Aged 20-35 years

Active Comparator

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.

Intervention: Free gingival graft operation (Procedure)

Adult group: Aged 50-65 years

Active Comparator

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.

Intervention: Free gingival graft operation (Procedure)

Outcomes

Primary Outcomes

Shrinkage percentage (%)

Time Frame: from baseline to 1-,3-,6- months

Shrinkage percentage of the graft area due to the changes in graft dimensions

Secondary Outcomes

  • VEGF levels (pg/ml)(from baseline to 1-,3-,6- months)
  • EGF levels (pg/ml)(baseline to 1-,3-,6- months)
  • TGFβ-1 levels (pg/ml)(from baseline to 1-,3-,6- months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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