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NCT Number: 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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Faculty of Dentistry

Istanbul, Maltepe, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Free gingival graft operation

Procedure

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

Primary outcomes

  1. 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

  1. VEGF levels (pg/ml)

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

    change in wound fluid VEGF levels from baseline to 1-,3-,6- months after surgery

  2. EGF levels (pg/ml)

    Time frame: baseline to 1-,3-,6- months

    change in wound fluid EGF levels from baseline to 1-,3-,6- months after surgery

  3. TGFβ-1 levels (pg/ml)

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

    change in wound fluid TGFβ-1 levels from baseline to 1-,3-,6- months after surgery

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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