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Completed

NCT Number: NCT06950359

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Samsun, 55270, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gelatin Sponge Dressing (Cutanplast®)

Device

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

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.

Polyglycolic Acid Sheet (Neoveil®)

Device

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

Primary outcomes

  1. MMS (Modified Manchester Scar Scale)

    Time frame: Post-operative days 7, 14, and 1st month

    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

  2. Landry, Turnbull and Howley (LTH) healing index

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

    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

  3. Epithelialization (H₂O₂ bubbling test)

    Time frame: Post-operative day 7, day 14 and 1st month

    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

  4. VAS pain score

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

    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

Secondary outcomes

  1. VAS burning sensation score

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

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

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Evaluation of the Effects of Cyanoacrylate and Polyglycolic Acid-Based Wound Dressings on Secondary Wound Healing

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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