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

Not Applicable

Completed

• Conditions: Non-Fluoride Enamel Opacities; Fluorosis, Dental; Dentin Sensitivity
• Interventions: Procedure: Fluorosed Group; Procedure: Non Flourosed Group

• Registration Number: NCT03237793
• Lead Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

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).

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-07
• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-30
• Study First Posted: 2017-08-03
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• The following were set as the 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluorosed Group	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)
Non Flourosed Group	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

Primary Outcome Measures

Name	Time	Method
Reduction in hypersensitivity	30 minutes	The primary outcome that was assessed in the study was the reduction in dentinal hypersensitivity sensation. The visual analogue scale was used as a recording scale when tested with the tests for hypersensitivity, which were the testing with a blast of air, ice cold water testing and electrical tactile sensitivity testing using a scratch-o-meter.

Secondary Outcome Measures

Name	Time	Method
use of diode laser in reducing hypersensitivity	30 mins	Efficacy of treatment when diode laser is used alone as a treatment option after scaling and root planing.
use of desensitising agent alone	30 minutes	Efficacy of treatment when desensitising agent was used as monotherapy after scaling and root planing
combination of densensitising agent and diode laser	30 minutes	3. Efficacy of treatment when a combination of diode laser and desensitising agent was used after scaling and root planing, for the treatment of dentinal hypersensitivity.