Treatment of Hypersensitivity Using Diode Laser and Desensitising Agent on Fluorosed and Non-fluorosed Teeth

NCT ID: NCT03237793

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-09-30

Brief Summary

The present study was designed as a randomised controlled clinical trial which was unicenter, double-blinded, parallel designed study, according to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010. The study period was from July 2014 to September 2015.

Detailed Description

90 Patients visiting the Out Patient of Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital, Bengaluru, India, presenting with a chief complaint of dentinal hypersensitivity were enrolled in the study. Patients' age ranged from 18-60 years. The subjects interested in participating were explained in detail the treatment protocol. A verbal consent as well as a written informed consent was obtained from each patient Treatment of dentinal hypersensitivity with a combination of diode laser and potassium nitrate desensitising agent was considered as the test group and this was compared with diode lasers alone and desensitising agent alone as the positive control groups. The study was conducted in full accordance with the declared ethical principles (World Medical Association Declaration of Helsinki, version VII, 2013)13 and was approved by the Institutional review board of Krishnadevaraya College of Dental Science and Hospital, under the registration number of (ACA/DCD/SYN/KCODS - B/PG/2013-2014).

Conditions

Fluorosis, Dental; Non-Fluoride Enamel Opacities; Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fluorosed Group

45 patients for the fluorosis groupGROUP 1A: Patients with healthy fluorosed teeth receiving desensitising agent (potassium nitrate- RA Themoseal\*\*) treatment. (n=15) GROUP 1B: Patients with healthy fluorosed teeth receiving diode laser treatment$. (n=15) GROUP 1C: Patients with healthy fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA Thermoseal\*\*) treatment. (n=15)

Group Type: ACTIVE_COMPARATOR

Fluorosed Group

Intervention Type: PROCEDURE

A single episode of laser therapy with without potassium nitrate (RA Thermoseal\*) desensitising agent application was administered to the patients, A group only with desensitising paste and A group with desensitising paste and laser treatment depending on the study group they were assigned

Non Flourosed Group

45 patients for the non-fluorosis groupGROUP 2- Non Flourosed Group (n=45) GROUP 2A: Patients with healthy non fluorosed teeth receiving desensitising agent (potassium nitrate- RA Thermoseal\*\*) treatment. (n=15) GROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal\*\*) treatment. (n=15

Group Type: PLACEBO_COMPARATOR

Non Flourosed Group

Intervention Type: PROCEDURE

A single episode of laser† therapy with or without potassium nitrate (RA Thermoseal\*) desensitising agent application was administered to the patients, depending on the study group they were assignedGROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment$. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal\*\*) treatment.

Interventions

Fluorosed Group

A single episode of laser therapy with without potassium nitrate (RA Thermoseal\*) desensitising agent application was administered to the patients, A group only with desensitising paste and A group with desensitising paste and laser treatment depending on the study group they were assigned

Intervention Type: PROCEDURE

Non Flourosed Group

A single episode of laser† therapy with or without potassium nitrate (RA Thermoseal\*) desensitising agent application was administered to the patients, depending on the study group they were assignedGROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment$. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal\*\*) treatment.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • Patients with a positive response for hypersensitivity testing (Pashley, 1990) i.e. cold water testing using ice cold water (Trowbridge et al., 1980),

• Air blow test (Coleman and Kinderknecht, 2000),
• Electric tactile stimulation test (Camps and Pashley, 2003),
• Patients presenting with non-carious cervical lesions in the enamel (Loomba et al., 2013), fluorosed teeth wherein fluorotic enamel staining confirmed by clinical examination, healthy non fluorosed teeth, which was confirmed by clinical examination (Dean, 1934).

Exclusion Criteria

• Patients undergoing any form of restorative endodontic,
• Orthodontic treatment or crown restorations,
• Local defects including caries and fractures,
• Presence of any systemic diseases,
• Acute pain conditions (like apical periodontitis, periapical abscess),
• Presence of periodontal disease or a history of periodontal treatment in last 6 months,
• Usage of desensitising toothpaste or mouth rinse in the last 4 weeks,
• Patients allergic to ingredients used in the study product,
• Teeth with intrinsic stains caused by other reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rashmi Paramashivaiah, MDS

Role: PRINCIPAL_INVESTIGATOR

Krishnadevaraya college of dental sciences

Other Identifiers

02_D012_45912

Identifier Type: -

Identifier Source: org_study_id