Gingival Enlargement
Conditions
Keywords
Ozonized gel, Photobiomodulation Therapy, Surgical gingivectomy, Wound healing
Brief summary
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
Detailed description
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.
Interventions
DRUGozonized gel application
Application of ozonized gel to raw wound area following surgical gingivectomy.
DEVICEphotobiomodulation therapy using diode laser
Application of diode laser 635nm to wound area following surgical gingivectomy
Sponsors
Mennatullah osama ahmed zaki wahba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Patients indicated for surgical gingivectomy. 2. Adequate amount of keratinized tissue. 3. Average age between 18-40 years. 4. Well-educated patients as post-operative instructions need to be followed precisely. 5. Good oral hygiene with a full mouth O'Leary plaque index of less than or equal to 10% and a full mouth Gingival Index of zero
Exclusion criteria
1. History of smoking. 2. Patients who have any known systemic disease that interfere with performance of surgical gingivectomy or periodontal wound healing. 3. Patients who have any previous adverse reactions to the products (or similar products) used in this study. 4. Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing index (HI) using Landry index | day 3,7,14,28 post surgical gingivectomy | The healing index (HI) scores will be assessed on the basis of redness, presence of granulation tissues, bleeding, suppuration, and epithelialization. |
| Evaluation of epithelialization of the wound area | days 0,3,7,14,28 post surgical gingivectomy | 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. |
| Postoperative pain using the VAS | day 0. day 3, day 7, and day 14 post surgery. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival crevicular fluid sampling for Vascular Endothelial Growth Factor quantification | baseline(day 0), day 7,day14 and day 28 post gingivectomy | 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. |
Countries
Egypt
Outcome results
None listed