Clinical trial NCT06459947: Effect of Cyanoacrylate and Concentrated Growth Factor on Palatal Donor Site
Official title: Effect of Cyanoacrylate and Concentrated Growth Factor on Wound Healing and Patient Comfort at the Palatal Donor Site
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound Healing
Pain
Patient Comfort
Keywords: cyanoacrylate
free gingival graft
concentrated growth factor
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: VAS
timeFrame: 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.
measure: Epithelialization
timeFrame: The epithelialization is examined on the 7th, 14th, 21st, and 28th days
Secondary outcomes:
measure: Number of analgesic drugs
timeFrame: Number of analgesic drugs is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.
measure: Healing Index
timeFrame: The Healing Index is recorded on the 7th day.
measure: Color Match
timeFrame: The color match is evaluated on the 7th, 14th, 21st and 28th days.
measure: Secondary Bleeding
timeFrame: Post-operative bleeding is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yuzuncu Yil University
Study officials:
affiliation: Van uzuncu Yil University
name: Dicle Altindal, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Van uzuncu Yil University
name: Elif Tore Sari, PhD
role: STUDY_CHAIR
affiliation: Van uzuncu Yil University
name: Nazli Zeynep Alpaslan, PhD
role: STUDY_CHAIR
References:
citation: 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.
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.