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

Primary Purpose

Gingival Overgrowth

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
External bevel gingivectomy
Diode laser Biostimulation
Hyaluronic acid (Gengigel) topical application.
Herbal gel (Hiora SG) topical application
Sponsored by
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Overgrowth

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Exclusion Criteria: Infrabony Pockets Diabetic patients Smokers.

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Sites / Locations

  • Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional Single arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Parameters
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.

Full Information

First Posted
May 29, 2018
Last Updated
November 5, 2018
Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03569683
Brief Title
Comparison Between Laser, Synthetic Gel and Herbal Gel as Topical Agents After Gum Surgery
Acronym
CLSHGTAGS
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Overgrowth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional Single arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
External bevel gingivectomy
Other Intervention Name(s)
Conventional Gingivectomy
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Diode laser Biostimulation
Intervention Description
After gingivectomy, laser irradiation will be done using bio-stimulation tip in the anterior sextants of the mouth. (Group A)
Intervention Type
Other
Intervention Name(s)
Hyaluronic acid (Gengigel) topical application.
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Herbal gel (Hiora SG) topical application
Intervention Description
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)
Primary Outcome Measure Information:
Title
Histological Assessment
Description
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.
Time Frame
Immediately Postoperatively and 6 weeks after gingivectomy.
Secondary Outcome Measure Information:
Title
Clinical Parameters
Description
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.
Time Frame
6 weeks after Gingivectomy procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Gingival enlargement index greater than or equal to 2mm Exclusion Criteria: Infrabony Pockets Diabetic patients Smokers. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sana Priyanka Reddy, (MDS)
Organizational Affiliation
PG Student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500060
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17069488
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.
Results Reference
background
PubMed Identifier
22395509
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.
Results Reference
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Comparison Between Laser, Synthetic Gel and Herbal Gel as Topical Agents After Gum Surgery

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