Comparing Two Wound Coverings for Healing and Comfort After Palatal Gum Graft Surgery in Adults

NCT06950359 | Completed

• 1 other identifier: B.30.2.ODM.0.20.08/712
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

After gum-grafting surgery, the bare spot in the palate can be slow to heal and quite sore. In this study, the investigators are trying three dressing methods to see which helps most: Standard care: gelatin sponge alone, Option A: gelatin sponge plus quick-dry tissue glue (cyanoacrylate), Option B: gelatin sponge plus a dissolvable mesh (polyglycolic acid). Investigators will enroll 45 adults having a free gingival graft and randomly assign 15 people to each group. Once the graft is taken, investigators will apply and suture in the assigned dressing. Follow-up visits will occur at 1 and 2 weeks, and at 1 and 2 months. Investigators will evaluate: Wound healing using two simple scales-how fast the site repairs (LTH index) and (MMS). Pain and burning sensations will also be recorded using a visual analog scale (VAS). By comparing these three approaches, investigators hope to find which dressing speeds recovery, improves the final result, and keeps discomfort to a minimum.

Conditions

Wound Healing

Keywords

Secondary wound healing; Periodontal surgery; Palatal wound healing; Cyanoacrylate tissue adhesive; Polyglycolic acid dressing

Outcome Measures

Primary Outcomes (4)

• MMS (Modified Manchester Scar Scale)

  Healing quality assessed by scoring color, contour, and distortion. Each category: 0 (best) to 2 (worst). Total score: 0 (best) to 6 (worst). Scale Range: 0-6 Directionality: Lower scores = better outcome

  Post-operative days 7, 14, and 1st month

• Landry, Turnbull and Howley (LTH) healing index

  Healing quality scored from 1 (very poor) to 5 (excellent) based on redness, bleeding, granulation, epithelialization, and suppuration. Scale Range: 1-5 Directionality: Higher scores = better outcome

  Post-operative day 7, day 14, 1st month and 2nd month

• Epithelialization (H₂O₂ bubbling test)

  Complete epithelialization assessed using 3% hydrogen peroxide. Positive (bubbles present) = no epithelialization Negative (no bubbles) = complete epithelialization Scale Type: Binary (Positive/Negative) Directionality: Negative result = better outcome

  Post-operative day 7, day 14 and 1st month

• VAS pain score

  Assessed using a 0-100 modified Visual Analog Scale (VAS), where 0 = no pain and 100 = worst imaginable pain. Patients recorded pain levels daily for 7 days. Additional follow-ups occurred on Day 14, and Month 1. Scale Range: 0-100 Directionality: Higher scores = worse outcome

  Post-operative days 1-7, 14th day and 1st month

Secondary Outcomes (1)

• VAS burning sensation score

  Post-operative days 1-7, 14th day and 1st month

Study Arms (3)

Gelatin Sponge (Control Group)

ACTIVE COMPARATOR

Participants (n=15) received a gelatin sponge dressing (Cutanplast®) placed over the palatal donor site and secured with crossed sling sutures around adjacent teeth.

Device: Gelatin Sponge Dressing (Cutanplast®)

Cyanoacrylate Group (Test Group 1)

EXPERIMENTAL

Participants (n=15) received a gelatin sponge dressing (Cutanplast®), followed by application of cyanoacrylate tissue adhesive (PeriAcryl®) to the sponge and wound margins. The dressing was stabilized using crossed sling sutures.

Device: Gelatin Sponge Dressing (Cutanplast®); Device: Cyanoacrylate Tissue Adhesive (PeriAcryl®)

Polyglycolic Acid Group (Test Group 2)

EXPERIMENTAL

Participants (n=15) received a gelatin sponge dressing (Cutanplast®) covered with a polyglycolic acid sheet (Neoveil®), trimmed to fit the wound and fixed with crossed sling sutures.

Device: Gelatin Sponge Dressing (Cutanplast®); Device: Polyglycolic Acid Sheet (Neoveil®)

Interventions

Gelatin Sponge Dressing (Cutanplast®) DEVICE

Absorbable gelatin-based hemostatic sponge used for all study groups as a wound contact dressing.

Cyanoacrylate Group (Test Group 1); Gelatin Sponge (Control Group); Polyglycolic Acid Group (Test Group 2)

Cyanoacrylate Tissue Adhesive (PeriAcryl®) DEVICE

High-viscosity N-Butyl Cyanoacrylate/2-Octyl Cyanoacrylate adhesive applied as a topical barrier to the palatal wound site in the Cyanoacrylate Group.

Cyanoacrylate Group (Test Group 1)

Polyglycolic Acid Sheet (Neoveil®) DEVICE

Bioresorbable PGA sheet placed over the gelatin sponge in the Polyglycolic Acid Group to enhance wound protection and healing.

Polyglycolic Acid Group (Test Group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older
• Good oral hygiene
• Not using any medications that affect wound healing
• No systemic diseases that may impair the normal healing process
• Non-smokers
• No clotting disorders
• Not being pregnant or in the lactation period (for female patients)

You may not qualify if:

• Patients with systemic conditions (e.g., diabetes, radiotherapy/chemotherapy, etc.)
• Individuals using any medication that may affect wound healing
• Individuals with coagulation disorders
• Smokers
• Pregnancy and breastfeeding
• Poor oral hygiene
• Patients who do not attend follow-up appointments regularly

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs Üniversitesi Diş Hekimliği Fakültesi - Ondokuz Mayis University Faculty of Dentistry

Samsun, Samsun, 55270, Turkey (Türkiye)

Location

Study Officials

• Hooman Hashemzadeh, DDS

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

• Umur Sakallıoğlu, PHD

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 30, 2025
• Study Start: January 7, 2024
• Primary Completion: December 14, 2024
• Study Completion: January 14, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)