Effect of Cyanoacrylate and Concentrated Growth Factor on Palatal Donor Site

Pain Clinical Trial

Official title:

Effect of Cyanoacrylate and Concentrated Growth Factor on Wound Healing and Patient Comfort at the Palatal Donor Site

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459947
• Other study ID #: 28.02.2024/07
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2024
• Est. completion date: October 15, 2024

Study information

• Verified date: June 2024
• Source: Yuzuncu Yil University
• Contact: Dicle Altindal, DDS
• Phone: +905536056372
• Email: dtdicle[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 15, 2024
• Est. primary completion date: August 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain
• Patient Comfort
• Wound Healing

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Van Yuzuncu Yil University	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Number of analgesic drugs	Patients are asked to note the number of analgesics they took for pain during the first week.	Number of analgesic drugs is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.
Secondary	Healing Index	The Healing Index is recorded with a 5-level score ranging from 1 (very poor) to 5 (excellent).	The Healing Index is recorded on the 7th day.
Secondary	Color Match	The color match is evaluated by Visual analogue scale (VAS). (0: no color match, 10: perfect color match)	The color match is evaluated on the 7th, 14th, 21st and 28th days.
Secondary	Secondary Bleeding	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.	Post-operative bleeding is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.