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

NCT03569683 | Completed DMC

• 2 other identifiers: PMVIDS16201105032D
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Overgrowth

Outcome Measures

Primary Outcomes (1)

• Histological Assessment

  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.

  Immediately Postoperatively and 6 weeks after gingivectomy.

Secondary Outcomes (1)

• Clinical Parameters

  6 weeks after Gingivectomy procedure

Study Arms (1)

Interventional Single arm

EXPERIMENTAL

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.

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

Interventions

External bevel gingivectomy PROCEDURE

External bevel gingivectomy will be performed on 30 patients wherein the suprabony pockets will be eliminated with the help of a Bard parker blade no 15. The incision would be given 1mm apical to the pockets which would be marked by a Crane and Kaplan pocket marker, then the incision would be given and the tissue would be removed with the help of kirkland and orbans knives and the gingiva would be shaped. After the surgical procedure the patients would be treated either with the Diode laser(Group A), Hyaluronic acid gel (Group B), or Herbal gel(Group C).

Also known as: Conventional Gingivectomy

Interventional Single arm

Diode laser Biostimulation DEVICE

After gingivectomy, laser irradiation will be done using bio-stimulation tip in the anterior sextants of the mouth. (Group A)

Interventional Single arm

Hyaluronic acid (Gengigel) topical application. OTHER

After gingivectomy, Hyaluronic acid gel(Gengigel) will be applied topically. Then it will be covered with a tin foil and periodontal dressing would be given. (Group B)

Interventional Single arm

Herbal gel (Hiora SG) topical application OTHER

After gingivectomy, Herbal gel(Hiora SG) will be applied topically. Then it will be covered with a tin foil and periodontal dressing would be given. (Group C)

Interventional Single arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre: lead

Study Sites (1)

Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre

Hyderabad, Telangana, 500060, India

Location

Related Publications (2)

• 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.

  PMID: 17069488 BACKGROUND

• 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.

  PMID: 22395509 BACKGROUND

MeSH Terms

Conditions

Gingival Overgrowth

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Sana Priyanka Reddy, (MDS)

  PG Student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 26, 2018
• Study Start: May 30, 2018
• Primary Completion: October 15, 2018
• Study Completion: October 30, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)