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

NCT03237793 | Completed

• 1 other identifier: 02_D012_45912
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Reduction in hypersensitivity

  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.

  30 minutes

Secondary Outcomes (3)

• use of diode laser in reducing hypersensitivity

  30 mins

• use of desensitising agent alone

  30 minutes

• combination of densensitising agent and diode laser

  30 minutes

Study Arms (2)

Fluorosed Group

ACTIVE COMPARATOR

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)

Procedure: Fluorosed Group

Non Flourosed Group

PLACEBO COMPARATOR

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

Procedure: Non Flourosed Group

Interventions

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

Fluorosed Group

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.

Non Flourosed Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

MeSH Terms

Conditions

Fluorosis, Dental; Dentin Sensitivity

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rashmi Paramashivaiah, MDS

  Krishnadevaraya college of dental sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A unified stratified randomization, double blind controlled parallel designed was the type generated the allocation sequence. A skilled assistant enrolled the participants and assigned the participants to interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 3, 2017
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 8, 2017

Record last verified: 2017-07