Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gelatin Sponge Dressing (Cutanplast®) | Device | Absorbable gelatin-based hemostatic sponge used for all study groups as a wound contact dressing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| VAS burning sensation score | 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 | Post-operative days 1-7, 14th day and 1st month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hooman Hashemzadeh, DDS | Ondokuz Mayıs University | Principal Investigator |
| Umur Sakallıoğlu, PHD | Ondokuz Mayıs University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ondokuz Mayıs Üniversitesi Diş Hekimliği Fakültesi - Ondokuz Mayis University Faculty of Dentistry | Samsun | Samsun | 55270 | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|