Effect of Cyanoacrylate and Concentrated Growth Factor on Palatal Donor Site

NCT ID: NCT06459947

Last Updated: 2025-12-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-02

Study Completion Date

2025-07-28

Brief Summary

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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

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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.

Conditions

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Wound Healing Pain Patient Comfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Group 1 (Control group)

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

Group Type ACTIVE_COMPARATOR

Free gingival graft procedure

Intervention Type PROCEDURE

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

Group 2 (Cyanoacrylate group)

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

Group Type ACTIVE_COMPARATOR

Free gingival graft procedure

Intervention Type PROCEDURE

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

Group 3 (Concentrated Growth Factor group)

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.

Group Type ACTIVE_COMPARATOR

Free gingival graft procedure

Intervention Type PROCEDURE

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

Interventions

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Free gingival graft procedure

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuzuncu Yil University

OTHER

Sponsor Role lead

Responsible Party

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Dicle Altındal

DDS, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dicle Altindal, DDS

Role: PRINCIPAL_INVESTIGATOR

Yuzuncu Yil University

Elif Tore Sari, PhD

Role: STUDY_CHAIR

Yuzuncu Yil University

Nazli Zeynep Alpaslan, PhD

Role: STUDY_CHAIR

Yuzuncu Yil University

Locations

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Van Yuzuncu Yil University

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31104113 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34406492 (View on PubMed)

Other Identifiers

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28.02.2024/07

Identifier Type: -

Identifier Source: org_study_id

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