Comparison Between Laser, Synthetic Gel and Herbal Gel as Topical Agents After Gum Surgery

Not Applicable

Completed

• Conditions: Gingival Overgrowth
• Interventions: Procedure: External bevel gingivectomy; Device: Diode laser Biostimulation; Other: Hyaluronic acid (Gengigel) topical application.; Other: Herbal gel (Hiora SG) topical application

• Registration Number: NCT03569683
• Lead Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Brief Summary

This study would be conducted to assess the effectiveness of low-level laser therapy, hyaluronic acid gel and herbal gel as adjunctive aids in the healing of gingivectomy wounds. As the gingivectomy wound heals by secondary intention, this study aims to compare the healing potential of low-level laser therapy, hyaluronic acid gel and herbal gel when applied topically at baseline, 1st day,3rd day and 7th day after gingivectomy procedure.

Detailed Description

Low-level laser therapy applied to soft tissues stimulates specific metabolic processes in healing wounds. Major changes observed in wounds treated with low-level laser therapy(LLLT) include increased healthy granulation tissue formation with early epithelization, increased fibroblast proliferation and matrix synthesis.

Hyaluronic acid is a polysaccharide gel and it has many properties that make it a potentially ideal molecule for assisting in wound healing by inducing early granulation tissue formation, inhibiting inflammation, providing epithelial turnover and also aiding in connective tissue angiogenesis.

Hiora gel is a herbal astringent gel which helps in wound healing, reduces inflammation and also alleviates pain.

Study Timeline

• Study First Submitted: 2018-05-29
• Study Start: 2018-05-30
• Study First Submitted QC: 2018-06-23
• Study First Posted: 2018-06-26
• Primary Completion: 2018-10-15
• Study Completion: 2018-10-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Gingival enlargement index greater than or equal to 2mm

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Exclusion Criteria

Infrabony Pockets Diabetic patients Smokers.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional Single arm	Hyaluronic acid (Gengigel) topical application.	Group A- Diode laser biostimulation on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery. Group B- Hyaluronic acid (Gengigel) topical application on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery. Group C- Herbal gel (Hiora SG) topical application on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery.
Interventional Single arm	Herbal gel (Hiora SG) topical application	Group A- Diode laser biostimulation on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery. Group B- Hyaluronic acid (Gengigel) topical application on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery. Group C- Herbal gel (Hiora SG) topical application on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery.
Interventional Single arm	External bevel gingivectomy	Group A- Diode laser biostimulation on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery. Group B- Hyaluronic acid (Gengigel) topical application on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery. Group C- Herbal gel (Hiora SG) topical application on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery.
Interventional Single arm	Diode laser Biostimulation	Group A- Diode laser biostimulation on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery. Group B- Hyaluronic acid (Gengigel) topical application on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery. Group C- Herbal gel (Hiora SG) topical application on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery.

Primary Outcome Measures

Name	Time	Method
Histological Assessment	Immediately Postoperatively and 6 weeks after gingivectomy.	Change in gingival tissue healing will be assessed.0.5 mm of tissue will be taken from the interdental papilla distal to the canine and will be processed for examination using hematoxiline and eosin and picrosirus staining.

Secondary Outcome Measures

Name	Time	Method
Clinical Parameters	6 weeks after Gingivectomy procedure	Gingival tissue healing will be assessed on a 10 point visual analogue scale.Score in each tooth will be taken including one full interdental papilla; Visual Analogue Scale: will be used to quantify pain levels and patient's discomfort. The VAS consists of a horizontal line of 10 cm (100 mm) with two end-points representing 'no pain' and 'worst pain imaginable'. Patients will be asked to rate their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the 'no pain' marker is then measured with a ruler giving a pain score out of 10.; 0: No pain 1-3: Slight pain 3.1-6: Moderate pain 6.1-10: Severe pain.

Trial Locations

Locations (1)

Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre; 🇮🇳 Hyderabad, Telangana, India