Clinical trial NCT03569683: Comparison Between Laser, Synthetic Gel and Herbal Gel as Topical Agents After Gum Surgery
Official title: Efficacy of Low-level Laser Therapy, Hyaluronic Acid Gel and Herbal Gel as Adjunctive Tools in Gingivectomy Wound Healing-A Randomised Comparative Clinical and Histological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Overgrowth
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The patients will be equally divided into three groups. (Groups A,B\&C) All the cases will be prepared preoperatively with scaling and root planing, oral hygeine instructions, occlusal equilibration and dietary evaluation. External bevel gingivectomy will be performed wherein the inflamed gingiva will be excised and shaped.

Group A- The Surgical site will be treated with diode laser following gingivectomy procedure, immediately and on the 1st,3rd and 7th day after surgery.

Group B- Hyaluronic acid will be applied topically to the surgical site immediately after gingivectomy, tin foil would be placed and periodontal dressing given, and on the 1st,3rd and 7th day postoperatively.

Group C- Herbal gel will be applied topically and tin foil placed over which a periodontal dressing would be given immediately after the surgery and on the 1st,3rd and 7th day postoperatively.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria: Gingival enlargement index greater than or equal to 2mm

Exclusion Criteria: Infrabony Pockets Diabetic patients Smokers.

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Primary outcomes:
measure: Histological Assessment
timeFrame: Immediately Postoperatively and 6 weeks after gingivectomy.
Secondary outcomes:
measure: Clinical Parameters
timeFrame: 6 weeks after Gingivectomy procedure
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre
state: Telangana
Study officials:
affiliation: PG Student
name: Sana Priyanka Reddy, (MDS)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amorim JC, de Sousa GR, de Barros Silveira L, Prates RA, Pinotti M, Ribeiro MS. Clinical study of the gingiva healing after gingivectomy and low-level laser therapy. Photomed Laser Surg. 2006 Oct;24(5):588-94. doi: 10.1089/pho.2006.24.588.
citation: Martu S, Amalinei C, Tatarciuc M, Rotaru M, Potarnichie O, Liliac L, Caruntu ID. Healing process and laser therapy in the superficial periodontium: a histological study. Rom J Morphol Embryol. 2012;53(1):111-6.