Effect of Cyanoacrylate and Concentrated Growth Factor on Palatal Donor Site

NCT06459947 | Completed

• 1 other identifier: 28.02.2024/07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Healing; Pain; Patient Comfort

Keywords

cyanoacrylate; free gingival graft; concentrated growth factor

Outcome Measures

Primary Outcomes (2)

• VAS

  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)

  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.

• Epithelialization

  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.

  The epithelialization is examined on the 7th, 14th, 21st, and 28th days

Secondary Outcomes (4)

• Number of analgesic drugs

  Number of analgesic drugs is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.

• Healing Index

  The Healing Index is recorded on the 7th day.

• Color Match

  The color match is evaluated on the 7th, 14th, 21st and 28th days.

• Secondary Bleeding

  Post-operative bleeding is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.

Study Arms (3)

Group 1 (Control group)

ACTIVE COMPARATOR

After FGG is taken from the palatal area, the sponge is placed in the wound area.

Procedure: Free gingival graft procedure

Group 2 (Cyanoacrylate group)

ACTIVE COMPARATOR

After the FGG is taken from the palatal area, a cyanoacrylate tissue adhesive is placed in the wound area.

Procedure: Free gingival graft procedure

Group 3 (Concentrated Growth Factor group)

ACTIVE COMPARATOR

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.

Procedure: Free gingival graft procedure

Interventions

Free gingival graft procedure PROCEDURE

The palatal area is anesthetized using local anesthesia. The free gingival graft (FGG) is taken from the donor site with a scalpel.

Group 1 (Control group); Group 2 (Cyanoacrylate group); Group 3 (Concentrated Growth Factor group)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University

Van, 65080, Turkey (Türkiye)

Location

Related Publications (2)

• Lektemur Alpan A, Torumtay Cin G. PRF improves wound healing and postoperative discomfort after harvesting subepithelial connective tissue graft from palate: a randomized controlled trial. Clin Oral Investig. 2020 Jan;24(1):425-436. doi: 10.1007/s00784-019-02934-9. Epub 2019 May 18.

  PMID: 31104113 BACKGROUND

• Verissimo AH, Ribeiro AKC, Martins ARLA, Gurgel BCV, Lins RDAU. Comparative analysis of the hemostatic, analgesic and healing effects of cyanoacrylate on free gingival graft surgical wounds in donor and recipient areas: a systematic review. J Mater Sci Mater Med. 2021 Aug 18;32(9):98. doi: 10.1007/s10856-021-06573-z.

  PMID: 34406492 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dicle Altindal, DDS

  Yuzuncu Yil University

  PRINCIPAL INVESTIGATOR

• Elif Tore Sari, PhD

  Yuzuncu Yil University

  STUDY CHAIR

• Nazli Zeynep Alpaslan, PhD

  Yuzuncu Yil University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, Assistant Professor

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: March 2, 2024
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: April 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)