Use of Cyanoacrylate in Healing and Pain in the Palatal Donor Site of Connective Tissue Grafts

NCT06116539 | Unknown Phase 1

• 1 other identifier: cyanoacrylate multicenter
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontal plastic surgery has been performed successfully for a long time in the treatment of gingival recessions and mucogingival defects. Epithelial and connective tissue grafts are considered the "gold standard" treatment for gingival recession due to their biocompatibility and long-term stability, however they require tissue harvesting from a donor area, usually the palate, increasing patient discomfort. Various hemostatic and healing agents have been used in conjunction with suturing to speed healing and reduce complications associated with this procedure, such as bleeding and pain. These include absorbable synthetic collagen, absorbable gelatin sponges, oxidized regenerated cellulose, ferric subsulfate, and more recently, cyanoacrylate cements and platelet-rich fibrin. Cyanoacrylate adhesives are synthesized as monomers by condensation of a cyanoacetate with formaldehyde in the presence of catalysts and the adhesive film is developed by rapid polymerization caused by hydroxide groups to the surfaces to be adhered. The properties of cyanoacrylate tissue adhesives of greatest interest in the surgical field are excellent hemostasis, rapid tissue adhesion, and possible bacteriostatic qualities.

Conditions

Pain, Postoperative; Healing Surgical Wounds

Keywords

tissue adhesive; wound dressing; cyanoacrylate; gingival graft; palatal graft; conective tissue graft

Outcome Measures

Primary Outcomes (1)

• Pain perception

  The pain perceived by the patient will be evaluated by means of a Visual Analogue Scale (calibrated from 0 to 10, with 10 being the worst pain imaginable) during the first 1,2,3,4,5,6,7 and 14 days.

  Days 1,2,3,4,5,6,7 and 14 after the procedure

Secondary Outcomes (1)

• Donor site healing

  will be evaluated at 7 and 14 days after the procedure

Other Outcomes (1)

• intake of painkillers

  7 days after surgery

Study Arms (2)

Cyanoacrylate Group

EXPERIMENTAL

In the test group, a cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied.

Drug: Cyanoacrylate

Suture Group

ACTIVE COMPARATOR

In the control group, the edges will be approximated with 4/0 monofilament non-absorbable nylon suture (Aragó, Barcelona, Spain).

Procedure: Suture

Interventions

Cyanoacrylate DRUG

In the test group, a cyanoacrylate-based tissue adhesive (PeriAcryl 90 HV; Glustitch, Delta, Canada) will be applied.

Cyanoacrylate Group

Suture PROCEDURE

After harvesting the full-thickness connective tissue graft, the edges of the control group will be approximated with 4/0 non-absorbable monofilament nylon suture (Aragó, Barcelona, Spain).

Suture Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be considered a candidate for mucogingival treatment
• Requiring grafting around teeth or implants.
• No age limit is established for the sample.

You may not qualify if:

• Patients with systemic or scarring compromises
• Treated with bisphosphonates
• Smokers of more than 10 cigarettes a day
• With a history of previous palatal grafting in that location
• Present any type of contraindication to undergo surgery cannot take part in the study.

Sponsors & Collaborators

• Alfonso X El Sabio University: lead

Study Sites (1)

Joaquín López-Malla Matute

A Coruña, La Coruña, 15011, Spain

Location

Related Publications (6)

• Alhourani MA, Kasem T, Hamadah O. Comparative study between using a tissue adhesive (N-BCA & OCA) and surgical sutures in free gingival graft surgery: A randomized controlled clinical trial. Dent Med Probl. 2022 Apr-Jun;59(2):241-248. doi: 10.17219/dmp/135382.

  PMID: 35775864 BACKGROUND

• Basma HS, Saleh MHA, Abou-Arraj RV, Imbrogno M, Ravida A, Wang HL, Li P, Geurs N. Patient-reported outcomes of palatal donor site healing using four different wound dressing modalities following free epithelialized mucosal grafts: A four-arm randomized controlled clinical trial. J Periodontol. 2023 Jan;94(1):88-97. doi: 10.1002/JPER.22-0172. Epub 2022 Aug 3.

  PMID: 35754198 BACKGROUND

• Castro-Gaspar C, Olmedo-Gaya MV, Romero-Olid MN, Lisbona-Gonzalez MJ, Vallecillo-Rivas M, Reyes-Botella C. Comparison between Tissue Adhesive Cyanoacrylate and Suture for Palatal Fibromucosa Healing: A Randomized Controlled Study. Materials (Basel). 2021 Nov 19;14(22):7009. doi: 10.3390/ma14227009.

  PMID: 34832409 BACKGROUND

• Stavropoulou C, Atout RN, Brownlee M, Schroth RJ, Kelekis-Cholakis A. A randomized clinical trial of cyanoacrylate tissue adhesives in donor site of connective tissue grafts. J Periodontol. 2019 Jun;90(6):608-615. doi: 10.1002/JPER.18-0475. Epub 2018 Dec 26.

  PMID: 30517975 BACKGROUND

• Tavelli L, Asa'ad F, Acunzo R, Pagni G, Consonni D, Rasperini G. Minimizing Patient Morbidity Following Palatal Gingival Harvesting: A Randomized Controlled Clinical Study. Int J Periodontics Restorative Dent. 2018 Nov/Dec;38(6):e127-e134. doi: 10.11607/prd.3581.

  PMID: 30304077 BACKGROUND

• Tavelli L, Ravida A, Saleh MHA, Maska B, Del Amo FS, Rasperini G, Wang HL. Pain perception following epithelialized gingival graft harvesting: a randomized clinical trial. Clin Oral Investig. 2019 Jan;23(1):459-468. doi: 10.1007/s00784-018-2455-5. Epub 2018 Apr 30.

  PMID: 29713890 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cyanoacrylates; Sutures

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitriles; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Tissue Adhesives; Manufactured Materials; Technology, Industry, and Agriculture; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Joaquín LM Matute, dentistry

  Alfonso X El Sabio University

  STUDY DIRECTOR

Central Study Contacts

Joaquín LM Matute, dentistry

CONTACT

659350394; joaquinlopezmalla@gmail.com

Marc C Raga, student

CONTACT

692486116; marc.carceles@hotmail.es

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master on Oral Surgery, Implantology and Periodontic´s professor

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: November 3, 2023
• Study Start: January 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)