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The goal of this clinical trial is to compare the effect of photobiomodulation to ozonized gel on wound healing following gingivectomy procedure on adults. The main questions it aims to answer are:
Which treatment modality provides less painful and more efficient wound healing ? What are the patient's feedback on different treatment modalities ? Researchers will compare ozonized gel to photobiomodulation to normal gingivectomy procedure with no interference.
Participants will:
Receive either ozonized gel or photobiomodualtion treatment following surgical gingivectomy Visit the clinic every 3,7,14 and 28 days for checkups and investigations
Surgical gingivectomy is performed for elimination of supra bony pockets and gingival enlargements and it can be considered the gold standard treatment for such cases. The healing of wound site after gingivectomy occurs slowly by secondary intention; therefore, several studies have been conducted evaluating the effect of various treatment modalities to accelerate the process of wound healing such as use of ozonized gel and photobiomodulation. Ozone, owing to its biocompatibility, healing, and antimicrobial properties, is used for wound healing and tissue repair. Photobiomodulation Therapy (PBMT) using diode laser is another treatment modality regarded as an effective modality for the repair of tissues, control of pain and wound healing. This study will be carried out to clinically compare and evaluate the healing of surgical gingivectomy wounds using ozonized gel and PBMT.
Aim: Compare the efficacy of the ozonized gel to photobiomodulation therapy in wound healing following surgical gingivectomy Materials and Methods: This randomized controlled clinical trial will involve 48 surgical gingivectomy wound sites, equally divided into three groups, Group-I (test group1): ozonized hydrogel will be applied to raw wound area following surgical gingivectomy and at days 3,7,14 post surgery. Group II (test group 2): the surgical site will be irradiated with a diode laser (635 nm) directly following surgery and at days 3,7,14 postoperative. Group III (control group) will include surgical gingivectomies that will be left to heal spontaneously. Wound healing will be assessed using Landry's Healing index and by measuring degree of epithelialization, and pain level will be assessed using a Visual analog scale on the 3rd, 7th, 14th, and 28th days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozonized gel group | Active Comparator | Application of ozonized gel to raw wound area following surgical gingivectomy. |
|
| Photobiomodulation therapy group | Active Comparator | Application of diode laser 635nm to wound area following surgical gingivectomy |
|
| Control group | No Intervention | Spontaneous healing of wound area following surgical gingivectomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ozonized gel application | Drug | Application of ozonized gel to raw wound area following surgical gingivectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing index (HI) using Landry index | The healing index (HI) scores will be assessed on the basis of redness, presence of granulation tissues, bleeding, suppuration, and epithelialization. | day 3,7,14,28 post surgical gingivectomy |
| Evaluation of epithelialization of the wound area | A plaque disclosing agent is used to measure wound area epithelialization by dying the abraded and deepithelialized areas on the gingiva on postoperative days 3,7,14 and 28. By using this solution, assessment of degree of epithelialization and wound healing is made easier. Wound surface epithelialization in the obtaining photographs will be evaluated using an Image-analyzing software. To ensure standardization, all photographs will taken by the same person with the same camera at the same angle. | days 0,3,7,14,28 post surgical gingivectomy |
| Postoperative pain using the VAS | Visual Analogue Scale (VAS) is a simple measurement tool that measures the intensity of pain as recorded by the patient. 10-point visual analog scale of pain rating, with 0 marked as "no pain" and 10 marked as "worst pain imaginable | day 0. day 3, day 7, and day 14 post surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival crevicular fluid sampling for Vascular Endothelial Growth Factor quantification | Vascular Endothelial Growth Factor (VEGF) was analyzed from gingival crevicular fluid (GCF) at baseline, days 7, 14, and 28 for biochemical analysis using ELISA kit. | baseline(day 0), day 7,day14 and day 28 post gingivectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | 5310002 | Egypt |
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| photobiomodulation therapy using diode laser | Device | Application of diode laser 635nm to wound area following surgical gingivectomy |
|
| ID | Term |
|---|---|
| D005885 | Gingival Hyperplasia |
| ID | Term |
|---|---|
| D019214 | Gingival Overgrowth |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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