Skip to main content
OpenTrials
Completed

NCT Number: NCT03237793

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluorosed Group

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

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.

Primary outcomes

  1. Reduction in hypersensitivity

    Time frame: 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 outcomes

  1. use of diode laser in reducing hypersensitivity

    Time frame: 30 mins

    Efficacy of treatment when diode laser is used alone as a treatment option after scaling and root planing.

  2. use of desensitising agent alone

    Time frame: 30 minutes

    Efficacy of treatment when desensitising agent was used as monotherapy after scaling and root planing

  3. combination of densensitising agent and diode laser

    Time frame: 30 minutes

    • 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.

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

Treatment of Hypersensitivity Using Diode Laser and Potassium Nitrate Desensitising Agent- a Comparison of Treatment Effects on Fluorosed and Non-fluorosed Teeth- an in Vivo Randomised Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 3, 2017
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.