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

Beirut Arab University

Status and phase: Enrolling; Early Phase 1

Conditions: Palate; Wound

Treatments: Other: Collagen sponge; Combination Product: Cyanoacrylate tissue adhesive

Study type: Interventional

Funder types: Other

Identifiers

NCT07086482

2024-H-0140-D-M-0588

Details and patient eligibility

About

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.

Full description

This study investigates new approaches to make management of the palatal donor area easier to the operator and more comfortable to the patient. More specifically, it compares the use of PeriAcryl glue (PA) to the use of collagen sponge after harvesting a free gingival graft from the palate in terms of wound healing and epithelization primarily, and patients satisfaction and oral health related quality of life secondarily.

Participants selection:

Healthy patients (with no systemic diseases or coagulation disorders) requiring a free gingival graft to treat a gingival recession or keratinized tissue deficiency around implants and natural teeth will be recruited.

Participants included in this study must have clinically healthy gingiva and good oral hygiene.

Participants grouping:

• Control group: Hemostasis will be achieved by collagen sponge stabilized with 4/0 silk (x) suture on the palatal wound.
• Test group: Cyanoacrylate tissue adhesive (Periacryl®, GluStitch Inc., Canada) will be applied with a pipette following manufacturer's instructions on the entire area of the wound.

All the procedures will be achieved with the full knowledge and consent of the patient. A written informed consent will be obtained for each patient included in this study.

Surgical Protocol:

• Full mouth scaling will be done for every patient at least 2 weeks before the surgery.
• The donor area will be anesthetized using articaine 4% with epinephrine 1:100,000.
• Palatal tissue thickness will be measured using a periodontal probe. Then a free gingival graft (FGG) will be harvested using a 15c blade of 1 to 1.5 mm in thickness, approximately 3 mm away from the palatal gingival margin.
• Pressure will be applied to the donor surface using gauze soaked in saline solution to stop bleeding, while the FGG will be prepared, stabilized and sutured at the recipient site.
• The operator will then receive a sealed envelope holding each patient's assigned grouping as soon as the graft extraction process is finished.

Post-operative Care:

All patients will get the same prescription of antibiotics (Amoxiclave 1g) twice daily for 7 days, and Ibuprofen 600 mg every 8 hours only taken when needed. As well as chlorohexidine 0.12% mouthwash twice daily for 2 weeks.

The same instructions will be given to all the patients (cease smoking, soft diet, oral hygiene, not brushing hard and causing trauma to the surgical site...).

The test group participants receiving PA in the palatal donor will be informed about the material and that it will disintegrate on its own after 10 days.

While the control group participants receiving collagen sponge with (x) sutures in the palatal donor will be informed that the sutures will be removed after 2 weeks.

Following the operation, a questionnaire will be given to each patient asking them to record any spontaneous bleeding of the surgical incision during the first seven days following the procedure, as well as to rate their level of postoperative discomfort using a visual analogue scale (VAS), quantity of analgesics taken, and other questions related to quality of life.

Follow-ups:

All patients will be followed-up at 7, 14, 21 days, 1 month, 2 months, and 3 months, to evaluate healing up to the formation of the first epithelial layer as evaluated by pressure with a periodontal probe and Laundry wound healing index, and the time of complete integrity of the treated palatal fibromucosa.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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%

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Collagen sponge

Study Group

Experimental group

Description:

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.

Treatment:

Combination Product: Cyanoacrylate tissue adhesive