Cyanoacrylate With or Without Suture?

NCT ID: NCT06083259

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-05
• Study Completion Date: 2024-08-16

Brief Summary

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.

Conditions

Wound Heal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

gelatin sponge + cyanoacrylate + suspending sutures

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.

Group Type: ACTIVE_COMPARATOR

Gelatin sponge stabilization with suture and cyanoacrylate

Intervention Type: DEVICE

The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, Ethicon, USA)+ supporting sutures (control group)

gelatin sponge + cyanoacrylate

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.

Group Type: ACTIVE_COMPARATOR

Gelatin sponge stabilization with cyanoacrylate

Intervention Type: PROCEDURE

Seconder The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, USA) (test group)

Interventions

Gelatin sponge stabilization with suture and cyanoacrylate

The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, Ethicon, USA)+ supporting sutures (control group)

Intervention Type: DEVICE

Gelatin sponge stabilization with cyanoacrylate

Seconder The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, USA) (test group)

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Gencay Keceli

Assoc. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Palatal Wound Healing

Identifier Type: -

Identifier Source: org_study_id