Effect of Cyanoacrylate Tissue Adhesive Versus Collagen Sponge on Palatal Donor Site Healing

NCT07086482 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 2024-H-0140-D-M-0588
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the use of cyanoacrylate glue (PeriAcryl) is effective in healing of the palatal donor site in adults requiring a free gingival graft. The main question\[s\] it aims to answer \[is/are\]: Does PeriAcryl accelerate the palatal tissue healing compared with the use of collagen sponge? Does PeriAcryl usage leave the patients more satisfied? Researcher will compare the outcomes of participants treated with PeriAcryl to those treated with collagen sponge to see if PeriAcryl accelerated the healing process of palatal tissues and led to fewer postoperative complications. Participants will:

• be assigned to a study group using PeriAcryl or control group using Collagen sponge.
• be followed-up to monitor healing and gather clinical information.

Conditions

Palate; Wound

Keywords

palatal donor area; Cyanoacrylate glue; wound healing; free gingival graft

Outcome Measures

Primary Outcomes (3)

• Healing of palatal wound

  Healing will be evaluated using Laundry Wound Healing Index (WHI). WHI has a score range of 1 (very poor) to 5 (excellent), evaluates tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins, and amount of suppuration.

  1 month, 2 months and 3 months post-operatively.

• Epithelization of the palatal wound

  The complete epithelialization will be evaluated clinically by applying 3% hydrogen peroxide into the palatal wound. If bubble formation is not observed, epithelization will be recorded as complete, whereas if bubbles are observed, epithelization will be recorded as incomplete.

  On every follow-up session: 7 days, 14 days, 21 days, 1 month, 2 months and 3 months post-operatively.

• Color Match

  Tissue color match (CM) will be assessed with adjacent and contralateral palatal tissue (0-no color matching to 10-excellent color matching).

  3 months post-operatively

Secondary Outcomes (6)

• Post-operative Pain

  Every day for 7 days, and on the 14th day.

• Inflammation Degree

  Every day for 7 days, and on the 14th day.

• Post-operative Bleeding

  Every day for 7 days, and on the 14th day.

• Presence of Hyperesthesia

  Every day for 7 days, and on the 14th day.

• Number of Analgesic Pills Taken

  During the first 14 days post-operatively.

Study Arms (2)

Collagen sponge

ACTIVE COMPARATOR

Participants will be treated with collagen sponge at the palatal donor wound to achieve hemostasis. After FGG harvest, pressure will be applied at the palatal wound using a gauze soaked in saline to top the bleeding, then a collagen sponge will be placed and stabilized with 4/0 silk (x) sutures.

Device: Collagen sponge

Cyanoacrylate tissue adhesive

EXPERIMENTAL

Participants will be treated with cyanoacrylate tissue adhesive (PeriAcryl) at the palatal donor wound to achieve hemostasis. After FGG harvest, pressure will be applied at the palatal wound using a gauze soaked in saline to top the bleeding, then PeriAcryl will be applied with a pipette following manufacturer's instructions on the entire area of the wound.

Combination Product: Cyanoacrylate tissue adhesive

Interventions

Cyanoacrylate tissue adhesive COMBINATION_PRODUCT

Cyanoacrylate tissue adhesive is a chemical synthetic and hybrid tissue sealant possessing strong, rapid acting adhesive properties and is often used in general surgery. Recently, cyanoacrylate tissue adhesive has been effectively introduced into dentistry to close wounds and stop ischemic areas from forming in periodontal aesthetic surgeries. As well as in exposed membranes to preserve the bone graft after guided bone regeneration, in post-extraction sockets, and to seal any surgical flap. This material has strong hemostatic, bacteriostatic, and sealing qualities.

Also known as: PeriAcryl

Cyanoacrylate tissue adhesive

Collagen sponge DEVICE

Collagen sponge is an organic polymer that promotes the development of blood clots, and it resorbs quickly and completely over time. Collagen sponge create a matrix at the bleeding site, encourage platelet activation and aggregation, and engage the extrinsic coagulation pathway. Thus, it can be utilized as the first choice for wound healing.

Collagen sponge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low-moderate anesthetic risk (ASA I-II)
• No restriction on ethnicity or gender
• Patients requiring FGG from the palate for periodontal plastic surgery
• Clinically healthy gingiva after phase I therapy
• Full-mouth plaque index grades 0 and 1
• Bleeding scores \<15%

You may not qualify if:

• Patients who smoke \> 10 cigarettes/day
• Patients with coagulation disorders
• Systemic diseases
• Patients on certain medications that may affect periodontal tissues
• Pregnant and lactating patient
• Patients with allergies to drugs that will be prescribed during the treatment phase
• Pathological mental conditions (dementia, psychosis) and lack of cooperation
• Excessive gag reflex

Sponsors & Collaborators

• Beirut Arab University: lead

Study Sites (1)

Beirut Arab University

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Nayer Aboelsaad

  Professor

  STUDY CHAIR

Central Study Contacts

Dania EL Rostom, MSc Oral and Dental Surgery

CONTACT

+96171659355; daniarostom1999@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: August 4, 2025
• Primary Completion: March 20, 2026
• Study Completion: April 20, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

LE (1)