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

NCT06749119 | Active Not Recruiting

• 1 other identifier: 09.2020.660
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Healing; Tissue Grafts; Age; Vegf; TGF-β

Outcome Measures

Primary Outcomes (1)

• Shrinkage percentage (%)

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

  from baseline to 1-,3-,6- months

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Procedure: Free gingival graft operation

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.

Procedure: Free gingival graft operation

Interventions

Free gingival graft operation PROCEDURE

Free gingival graft was harvested from palatal region and stabilized on the maxillary anterior recipient bed with sutures .

Adult group: Aged 50-65 years; Young group: Aged 20-35 years

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: April 14, 2023
• Primary Completion: December 27, 2024
• Study Completion: December 27, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)