Fluorosis, DentalNCT03237793
Treatment of Hypersensitivity Using Diode Laser and Desensitising Agent on Fluorosed and Non-fluorosed Teeth
A study testing Fluorosed Group and Non Flourosed Group in people with Fluorosis, Dental and Non-Fluoride Enamel Opacities, run by Krishnadevaraya College of Dental Sciences & Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluorosis, Dental, Non-Fluoride Enamel Opacities, Dentin Sensitivity
- What is being tested?
- Fluorosed Group and Non Flourosed Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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).
Who cannot join
- 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),
Show all 10Show fewer
- 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.
About this study
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
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.
Read the 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).
- Being tested
- Fluorosed Group, Non Flourosed Group
- Medical subject headings
- Fluorosis, Dental, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorosed GroupProcedure or surgery
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 GroupProcedure or surgery
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$. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal**) treatment.
| Study group | Role | What they receive |
|---|---|---|
| Fluorosed Group | Active comparator | 45 patients for the fluorosis groupGROUP 1A: Patients with healthy fluorosed teeth receiving desensitising agent (potassium nitrate- RA Themoseal) treatment. (n=15) GROUP 1B: Patients with healthy fluorosed teeth receiving diode laser treatment$. (n=15) GROUP 1C: Patients with healthy fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA Thermoseal) treatment. (n=15) Receives: 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 Receives: Procedure: Non Flourosed Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (3)
use of diode laser in reducing hypersensitivity
Efficacy of treatment when diode laser is used alone as a treatment option after scaling and root planing.
Measured: 30 mins
use of desensitising agent alone
Efficacy of treatment when desensitising agent was used as monotherapy after scaling and root planing
Measured: 30 minutes
combination of densensitising agent and diode laser
- 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study startJul 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluorosis, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rashmi Paramashivaiah, MDS, Principal investigator, Krishnadevaraya college of dental sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237793
- Sponsor's protocol ID
- 02_D012_45912
- Status last verified
- Jul 2017
- First submitted
- 26 Jul 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03237793
- Acronym / sponsor ID
- 02_D012_45912
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fluorosed Group | Active comparator | Procedure: Fluorosed Group45 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$. (n=15) GROUP 1C: Patients with healthy fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA Thermoseal) treatment. (n=15) |
| Non Flourosed Group | Placebo comparator | Procedure: Non Flourosed Group45 patients for the non-fluorosis groupGROUP 2- Non Flourosed Group (n=45) GROUP 2A: Patients with healthy non fluorosed teeth receiving desensitising agent (potassium nitrate- RA Thermoseal) treatment. (n=15) GROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal) treatment. (n=15 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Patients with a positive response for hypersensitivity testing (Pashley, 1990) i.e. cold water testing using ice cold water (Trowbridge et al., 1980),
Key exclusion criteria (10 listed)
- The following were set as the exclusion criteria;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorosed GroupA single episode of laser therapy with without potassium nitrate (RA Thermoseal*) desensitising agent application was administered to the patients, A group only with desensitising paste and A group with desensitising paste and laser treatment depending on the study group they were assigned | Procedure or surgery | Fluorosed Group |
| Non Flourosed GroupA single episode of laser† therapy with or without potassium nitrate (RA Thermoseal*) desensitising agent application was administered to the patients, depending on the study group they were assignedGROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment$. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal**) treatment. | Procedure or surgery | Non Flourosed Group |
Primary outcome
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.
3 secondary outcomes
use of diode laser in reducing hypersensitivity
Time frame: 30 mins
use of desensitising agent alone
Time frame: 30 minutes
combination of densensitising agent and diode laser
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
Related trials for Fluorosis, Dental
Enrolling by invitation
Design of a Multicomponent Intervention to Reduce the Risk of Exposure Fluorine
Fluorosis, Dental, Fluorosis
Active, not recruiting
Design of a Multicomponent Intervention to Reduce the Risk of Exposure Fluorine
Fluorosis, Dental, Fluorosis
Not yet recruitingObservational study
Clinical Severity of Dental Fluorosis and Associated Risk Factors Among a Group of Children in Rural Region, Dendera Center in Egypt
Dental Fluorosis
RecruitingObservational study
Colorimetric, Ultra-structural and Elemental Comparison of Dental Enamel Defects
Amelogenesis Imperfecta, Dental Fluoroses
Not yet recruitingPhase 4
21% Hydrochloric Acid Based Versus 6.6 % Hydrochloric Based Micro Abrasive Kit in Management of Patients With Mild to Moderate Fluorosis
Enamel Discoloration, Fluorosis, Dental
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rashmi Paramashivaiah, MDS principal investigator
Krishnadevaraya college of dental sciences
Questions about this trial
What is this clinical trial studying?
A study testing Fluorosed Group and Non Flourosed Group in people with Fluorosis, Dental and Non-Fluoride Enamel Opacities, run by Krishnadevaraya College of Dental Sciences & Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in hypersensitivity (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.