The Effects of Zn-containing Granulate on Patient Morbidity and Wound Healing After Free Gingival Graft Surgery

Study Overview
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Brief Summary
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There is no study in the literature showing the effects of Zn on wound healing after free gingival graft (FGG) operation. The aim of this randomized clinical study was to compare the early healing results of the palatal wound after FGG harvesting by sterile hemostatic agent suturing or the use of surgical stent from thermoplastic Zn-containing granules which was prepared chairside.

Detailed Description
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There are many studies reporting paresthesia, herpetic lesion, mucocele, excessive bleeding and severe postoperative pain after procedure.The highest pain level perceived in the palatal region after the FGG operation is experienced on the first day after the operation and decreases to the preoperative levels approximately 2 weeks after the operation. Although hemostatics, bioactive substances, antibacterial and antiseptic agents, herbal effective products, platelet concentrations, low-dose laser applications, palatal stents are used in the palatal region to accelerate the healing stages and prevent such complications, an ideal support has not been found.

Official Title
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Cukurova University Faculty of Dentistry

Conditions
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Surgery

Intervention / Treatment
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* Procedure: Zn granulate stent after FGG surgery
* Procedure: Hemostatic agent suturing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Periodontal and systemically healthy ≥19 years old Amount of attached gingival width in the maxillary or mandibular anterior region <2 mm Full mouth plaque index score, bleeding index score on full-mouth probing <15% Exclusion criteria; Previously undergone surgery for a graft harvested from the palate Presence of systemic disease Taking medication known to interfere with periodontal health Smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc granulate group<br>The patients in this group will receive a chair-side prepared surgical stent from Zn granulates on the palatal wound after FGG surgery. | Procedure: Zn granulate stent after FGG surgery<br>* Immediately after FGG harvesting from the palatal tissue, homeostasis was achieved by sterile wet gauzes and the ZnG was prepared according to the manufacturer guidelines. Briefly, approximately 10 grams of granulate was poured into hot water and then manually shaped to cover the surgical area. The retention was achieved from the palatal, occlusal and buccal surfaces of the teeth. The patient was asked to wear the ZnG for 7 days except for eating.(<br>|
| Active Comparator: Hemostatic agent group<br>The patients in this group will receive hemostatic agent sutured on the palatal wound after FGG surgery. | Procedure: Hemostatic agent suturing<br>* Immediately after FGG harvesting from the palatal tissue, homeostasis was achieved by sterile wet gauzes. Then hemostatic agent containing cellulose were sutured on the palatal wound area with 4.0 vicryl sutures in this group. Sutures were removed after 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Pain was scored from 0 to 10 experienced by the patients as a result of palatal wound (0: no pain, 1: minimal pain, 10: severe pain). | post operative 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Bleeding of the palatal wound was described as prolonged hemorrhaging after the surgery and was recorded 'yes' or 'no' | post operative 7 days | 
| Burning sensation | BS was assessed as the level of sense of burning of the palatal wound via Visual Analogue Scale (0:absent 10:severe burning) | post operative 8 weeks | 
| Change in dietary habits | evaluated according to inability to chew resulting from the presence of the palatal wound via Visual Analogue Scale (0: no changes 10: not capable of eating) | post operative 8 weeks | 
| Complete epithelization | evaluated clinically with the 3% Hydrogen Peroxide test. While the H2O2 epithelial barrier is intact, it doesn't diffuse into the connective tissue, and oxygen isn't released. The absence of bubbles after H2O2 application was considered as CE positive, and CE was recorded as a triple variable | post-operative 8 weeks | 
| Patient discomfort | PD was assessed by application of air spray for 5 seconds over the palatal site and then patients scored the VAS considering sensitive function (0: no discomfort, 10: extreme). | post-operative 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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free gingival graft surgery, surgical stent, zinc, pain, bleeding