Clinical trial NCT03237793: Treatment of Hypersensitivity Using Diode Laser and Desensitising Agent on Fluorosed and Non-fluorosed Teeth
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluorosis, Dental
Non-Fluoride Enamel Opacities
Dentin Sensitivity
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

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:

* 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.

Primary outcomes:
measure: Reduction in hypersensitivity
timeFrame: 30 minutes
Secondary outcomes:
measure: use of diode laser in reducing hypersensitivity
timeFrame: 30 mins
measure: use of desensitising agent alone
timeFrame: 30 minutes
measure: combination of densensitising agent and diode laser
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Krishnadevaraya college of dental sciences
name: Rashmi Paramashivaiah, MDS
role: PRINCIPAL_INVESTIGATOR
References: