Clinical trial NCT06950359: Comparing Two Wound Coverings for Healing and Comfort After Palatal Gum Graft Surgery in Adults
Official title: Evaluation of the Effects of Cyanoacrylate and Polyglycolic Acid-Based Wound Dressings on Secondary Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Keywords: Secondary wound healing
Periodontal surgery
Palatal wound healing
Cyanoacrylate tissue adhesive
Polyglycolic acid dressing
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MMS (Modified Manchester Scar Scale)
timeFrame: Post-operative days 7, 14, and 1st month
measure: Landry, Turnbull and Howley (LTH) healing index
timeFrame: Post-operative day 7, day 14, 1st month and 2nd month
measure: Epithelialization (H₂O₂ bubbling test)
timeFrame: Post-operative day 7, day 14 and 1st month
measure: VAS pain score
timeFrame: Post-operative days 1-7, 14th day and 1st month
Secondary outcomes:
measure: VAS burning sensation score
timeFrame: Post-operative days 1-7, 14th day and 1st month
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs Üniversitesi Diş Hekimliği Fakültesi - Ondokuz Mayis University Faculty of Dentistry
Study officials:
affiliation: Ondokuz Mayıs University
name: Hooman Hashemzadeh, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ondokuz Mayıs University
name: Umur Sakallıoğlu, PHD
role: STUDY_DIRECTOR
References: