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

NCT ID: NCT06749119

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-14

Study Completion Date

2024-12-27

Brief Summary

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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

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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.

Conditions

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Wound Healing Tissue Grafts Age Vegf TGF-β

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Free gingival graft operation

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Free gingival graft operation

Intervention Type PROCEDURE

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

Interventions

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Free gingival graft operation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Marmara University Faculty of Dentistry

Istanbul, Maltepe, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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09.2020.660

Identifier Type: -

Identifier Source: org_study_id