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

NCT ID: NCT03569683

Last Updated: 2018-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-30

Study Completion Date

2018-10-30

Brief Summary

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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

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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.

Conditions

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Gingival Overgrowth

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional Single arm

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.

Group Type EXPERIMENTAL

External bevel gingivectomy

Intervention Type 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).

Diode laser Biostimulation

Intervention Type DEVICE

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

Hyaluronic acid (Gengigel) topical application.

Intervention Type 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)

Herbal gel (Hiora SG) topical application

Intervention Type 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)

Interventions

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External bevel gingivectomy

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 PROCEDURE

Diode laser Biostimulation

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

Intervention Type DEVICE

Hyaluronic acid (Gengigel) topical application.

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

Herbal gel (Hiora SG) topical application

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)

Intervention Type OTHER

Other Intervention Names

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Conventional Gingivectomy

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sana priyanka

Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sana Priyanka Reddy, (MDS)

Role: PRINCIPAL_INVESTIGATOR

PG Student

Locations

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Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre

Hyderabad, Telangana, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 17069488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22395509 (View on PubMed)

Other Identifiers

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16201105032D

Identifier Type: OTHER

Identifier Source: secondary_id

PMVIDS

Identifier Type: -

Identifier Source: org_study_id

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