Effect of Cyanoacrylate and Concentrated Growth Factor on Palatal Donor Site

Not Applicable

Recruiting

• Conditions: Wound Healing; Pain; Patient Comfort
• Interventions: Procedure: Free gingival graft procedure

• Registration Number: NCT06459947
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

The aim of this planned randomized controlled clinical study is to evaluate the morbidity of the palatal donor area after free gingival graft (FGG) operations. In this study, wound healing and pain levels in the palatal region will be evaluated after cyanoacrylate and concentrated growth factor (CGF) applications.

Detailed Description

Free gingival graft obtained in the palatal region causes morbidity. Therefore, clinicians try to overcome these difficulties by isolating the wound in the palatal region from the oral environment and/or accelerating wound healing.

Periodontal dressings, acrylic stents, hemostatic agents, surgical sponges, platelet concentrates, low-level laser therapy, photobiomodulation, cyanoacrylate tissue adhesives and hyaluronic acid are some of the methods used for donor site management or to accelerate healing.

Cyanoacrylate adhesives form an adhesive film through rapid polymerization triggered by the hydroxyl groups on the surfaces to which they are applied. They have both bacteriostatic and hemostatic properties.

In recent years, it has been observed that the use of platelet concentrates such as Platelet Rich Plasma (PRP), Platelet Rich Fibrin (PRF) and autogenous products such as CGF (concentrated growth factor) in periodontal treatments has increased.

CGF is obtained by centrifuging blood in four different cycles and times. This product contains a relatively intact fibrin clot containing platelets, leukocytes, various growth factors and cytokines. CGF can be applied as a carrier of growth factors and/or a barrier membrane to aid tissue regeneration and wound healing in clinical applications.

The aim of this planned randomized controlled clinical study is to evaluate the morbidity of the palatal donor area after FGG operations. In this study, wound healing and pain levels in the palatal region will be evaluated after cyanoacrylate and CGF applications.

Study Timeline

• Study Start: 2024-03-02
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-03-03
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• systemically healthy
• not had periodontal surgery in the last 6 months

Exclusion Criteria

• smoker
• allergic to medication
• high anxiety (using modified dental anxiety scale)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2 (Cyanoacrylate group)	Free gingival graft procedure	After the FGG is taken from the palatal area, a cyanoacrylate tissue adhesive is placed in the wound area.
Group 1 (Control group)	Free gingival graft procedure	After FGG is taken from the palatal area, the sponge is placed in the wound area.
Group 3 (Concentrated Growth Factor group)	Free gingival graft procedure	After the FGG is taken from the palatal area, concentrated growth factor (CGF) group is placed in the wound area. CGF is obtained by centrifuging blood in four different cycles and times.

Primary Outcome Measures

Name	Time	Method
Epithelialization	The epithelialization is examined on the 7th, 14th, 21st, and 28th days	Hydrogen peroxide is used to detect epithelialization in the donor area after the operation. If epithelialization is not completed, H2O2 affects the catalase enzyme in the connective tissue and releases water and oxygen. Thus, clinically, it forms blisters on the palatal wound surface. Epithelialization scores will be divided into three groups: absent, partially epitheliazed and completely epithelialized.
VAS	The pain level is recorded every hour for the first 8 hours after the operation, and on the 2nd, 3rd, 4th, 5th, 6th, 7th days after the operation.	The patient is given a form to record the post-operative pain level in the palatial area with Visual analogue scale (VAS). The VAS is a scale that rates pain severity from 0 to 10. (0 = no pain to 10 = severe pain)

Secondary Outcome Measures

Name	Time	Method
Number of analgesic drugs	Number of analgesic drugs is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.	Patients are asked to note the number of analgesics they took for pain during the first week.
Color Match	The color match is evaluated on the 7th, 14th, 21st and 28th days.	The color match is evaluated by Visual analogue scale (VAS). (0: no color match, 10: perfect color match)
Healing Index	The Healing Index is recorded on the 7th day.	The Healing Index is recorded with a 5-level score ranging from 1 (very poor) to 5 (excellent).
Secondary Bleeding	Post-operative bleeding is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.	Post-operative bleeding in the palatal region is noted. The patient notes the postoperative bleeding status of the palatal area. Bleeding scores are recorded as yes or no.

Trial Locations

Locations (1)

Van Yuzuncu Yil University; 🇹🇷 Van, Turkey