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

NCT ID: NCT06950359

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-07
• Study Completion Date: 2025-01-14

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.

Detailed Description

Free gingival grafting (FGG) is a well-established periodontal procedure commonly used to increase keratinized tissue width or treat gingival recessions. However, harvesting tissue from the palate leaves a secondary wound at the donor site, which often heals by secondary intention. This can result in considerable postoperative discomfort, delayed epithelialization, and an increased risk of complications such as bleeding, infection, or scarring. This randomized, controlled clinical trial aims to compare the effectiveness of three different wound dressing approaches in promoting healing and reducing patient morbidity at the palatal donor site following FGG surgery. A total of 45 adult patients requiring FGG for periodontal or mucogingival indications will be enrolled and randomly assigned (1:1:1 ratio) into three groups: Control Group: Gelatin sponge (standard care), CYA Group (Option A): Gelatin sponge combined with a cyanoacrylate tissue adhesive (a fast-polymerizing topical glue) and PGA Group (Option B): Gelatin sponge combined with a bioresorbable polyglycolic acid (PGA) sheet. All materials used are biocompatible and approved for surgical application. After the graft is harvested, the assigned dressing will be sutured to the palatal wound under standard aseptic conditions. No additional protective stent will be used to isolate the effect of the test materials. The study is designed to evaluate and compare outcomes related to tissue healing, patient-reported pain, and wound appearance over a structured postoperative timeline. Patients will be followed up on Day 7, Day 14, and at 1 and 2 months after surgery. Objective Clinical Assessments include: Wound healing: Assessed via the Landry, Turnbull, and Howley (LTH) Index and Modified Manchester Scar Scale (MMS), Epithelialization: Measured using the hydrogen peroxide (H₂O₂) bubble test, a visual indicator of open vs. epithelialized tissue. Subjective Patient-Reported Outcomes: Pain and burning sensation: Recorded using a 0-100 Visual Analog Scale (VAS) during the first 7 postoperative days and at follow-up visits. This trial will explore whether the addition of cyanoacrylate or PGA dressing materials can improve clinical healing parameters and enhance patient comfort compared to standard gelatin sponge treatment. The hypothesis is that bioactive dressings may promote faster epithelialization and superior healing outcomes, while also minimizing early postoperative pain. The findings from this trial may contribute to developing best-practice protocols for donor site management following periodontal soft tissue grafting, with the potential to enhance recovery quality and patient satisfaction.

Conditions

Wound Healing

Study Design

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

Study Groups

Gelatin Sponge (Control Group)

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

Group Type: ACTIVE_COMPARATOR

Gelatin Sponge Dressing (Cutanplast®)

Intervention Type: DEVICE

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

Cyanoacrylate Group (Test Group 1)

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.

Group Type: EXPERIMENTAL

Gelatin Sponge Dressing (Cutanplast®)

Intervention Type: DEVICE

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

Cyanoacrylate Tissue Adhesive (PeriAcryl®)

Intervention Type: DEVICE

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

Polyglycolic Acid Group (Test Group 2)

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.

Group Type: EXPERIMENTAL

Gelatin Sponge Dressing (Cutanplast®)

Intervention Type: DEVICE

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

Polyglycolic Acid Sheet (Neoveil®)

Intervention Type: DEVICE

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

Interventions

Gelatin Sponge Dressing (Cutanplast®)

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

Intervention Type: DEVICE

Cyanoacrylate Tissue Adhesive (PeriAcryl®)

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

Intervention Type: DEVICE

Polyglycolic Acid Sheet (Neoveil®)

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Hooman Hashemzadeh

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hooman Hashemzadeh, DDS

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University

Umur Sakallıoğlu, PHD

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Locations

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

Samsun, Samsun, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B.30.2.ODM.0.20.08/712

Identifier Type: -

Identifier Source: org_study_id