Cyanoacrylate With or Without Suture?

Hacettepe University

Status: Completed

Conditions: Wound Heal

Treatments: Procedure: Gelatin sponge stabilization with cyanoacrylate; Device: Gelatin sponge stabilization with suture and cyanoacrylate

Study type: Interventional

Funder types: Other

Identifiers

NCT06083259

Palatal Wound Healing

Details and patient eligibility

About

An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge and cyanoacrylate or a collagen sponge, cyanoacrylate, and suspending sutures. Intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Inclusion Criteria:

• age ≥18;
• mucogingival surgical treatment indication that needs connective tissue graft in the anterior mandible;
• stable periodontium after phase I therapy;
• full-mouth plaque and bleeding scores <15%

Exclusion Criteria:

• previous palatal harvesting history;
• unstable endodontic conditions;
• tooth mobility at the surgical site;
• systemic disease;
• pregnancy;
• use of medications with potential adverse effects on periodontal tissues

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 2 patient groups

gelatin sponge + cyanoacrylate + suspending sutures

Active Comparator group

Description:

After administration of local anesthesia (2% articaine hydrochloride with epinephrine 1:100,000), palatal thickness will be measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area. Epithelialized gingival graft will be harvested. After a rectangular-shaped initial incision, a graft with 1-1.5 mm thickness will be harvested approximately 1.5 to 3 mm away from the gingival margins of the upper teeth. The donor site will be closed with a gelatin sponge + cyanoacrylate + suspending sutures.

Treatment:

Device: Gelatin sponge stabilization with suture and cyanoacrylate

gelatin sponge + cyanoacrylate

Active Comparator group

Description:

After local anesthesia (2% articaine hydrochloride with epinephrine 1:100,000) administration, palatal thickness will be measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and the mean value will be recorded as palatal tissue thickness. The epithelialized gingival graft will be harvested using 15 knives. After a rectangular-shaped initial incision, a graft with 1-1.5 mm thickness will be harvested approximately 1.5 to 3 mm away from the gingival margins of the upper teeth. The donor site will be closed with a gelatin sponge and cyanoacrylate without sutures.

Treatment:

Procedure: Gelatin sponge stabilization with cyanoacrylate