| CTRI Number |
CTRI/2025/09/094372 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Treatment of tooth sensitivity |
|
Scientific Title of Study
|
Comparative evaluation of the outcomes of diode laser (660nm) with 8% arginine containing toothpaste and diode laser (660nm) with fluoro calcium phospho silicate toothpaste in management of dentin hypersensitivity – a randomized split mouth clinical trial |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neetha J Shetty |
| Designation |
Professor and HOD |
| Affiliation |
Manipal Academy Of Higher Education, Manipal |
| Address |
Department of periodontology, 4th floor, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education,Manipal
Department of periodontology, 4th floor, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education,Manipal
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880858025 |
| Fax |
|
| Email |
neetha.rajesh@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neetha J Shetty |
| Designation |
Professor and HOD |
| Affiliation |
Manipal Academy Of Higher Education, Manipal |
| Address |
Department of periodontology, 4th floor, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal
Department of periodontology, 4th floor, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880858025 |
| Fax |
|
| Email |
neetha.rajesh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neetha J Shetty |
| Designation |
Professor and HOD |
| Affiliation |
Manipal Academy Of Higher Education, Manipal |
| Address |
Department of periodontology, 4th floor, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education,Manipal
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880858025 |
| Fax |
|
| Email |
neetha.rajesh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| self funded : Dr. Neetha J Shetty |
|
|
Primary Sponsor
|
| Name |
Dr Neetha J Shetty |
| Address |
Department of Peiodontology, Room no. 7, Manipal College of Dental Sciences, Mangalore Karnataka, India 575001 |
| Type of Sponsor |
Other [self funded - Dr. Neetha J Shetty] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neetha J Shetty |
Manipal College of Dental Sciences, Mangalore |
Department of Periodontology, room No. 7, 4th floor, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education,Mangalore -575001
Dakshina Kannada
KARNATAKA |
9880858025
neetha.rajesh@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dentinal hypersensitivity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL |
8% arginine containing desensitizing toothpaste is applied on the tooth surface using a microbrush for 1 minute and then irradiated with diode laser 660nm |
| Intervention |
TEST |
5% fluoro calcium phosphosilicate containing desensitising paste is applied on the tooth surface using a microbrush for 1 minute and then irradiated with diode laser 660nm |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 20 to 55 years irrespective of gender
Patients who agree to participate in the study by signing the informed consent
Systemically healthy patients having two or more teeth showing hypersensitivity to air blast or tactile stimulation in at least two quadrants
Full Mouth plaque Score less than 25 percent
|
|
| ExclusionCriteria |
| Details |
1. Allergy to any of the contents of the treatment.
2. Benign or malignant pathological oral lesions
3. Chronic disease
4. Chronic medication use
5. Caries in selected or neighbouring teeth, cracked enamel, orthodontic appliance, restorations, congenital enamel and/or dentin defects.
6. Patients with advanced periodontal disease or history of periodontal disease treatment
7. DH teeth with more than grade I mobility
8. Lactating or pregnant females
9. Patients using desensitizing dentifrice in the last 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tactile Hypersensitivity Measurement Using VAS
Sensitivity Assessment by Air Blast Using Schiff Cold Air Sensitivity Scale (SCASS) |
Baseline
15 post treatment
15TH DAY
30TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NONE |
NONE |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The combined use of laser and topical agents has been demonstrated to have additive or synergistic effects in the treatment of dentin hypersensitivity (DH), in addition to their individual effects. Topical agents are frequently used in conjunction with laser irradiation, a method that has been demonstrated to occlude dentinal tubules. The reapplication of laser irradiation is thought to improve the efficacy of desensitising paste (DP) containing 8% arginine. The effectiveness of desensitising paste (DP), which contains flouro calcium phosphosilicate, has also been shown in prior studies to be superior to other local agents in the treatment of dentin hypersensitivity, however it has not been compared toor used in conjunction with slow level laser (LLL) therapy utilising 660 nm. Thus the purpose of this study was to compare the effectiveness of LLL (660nm) with DP containing 8% arginine and LLL (660nm) with DP containing flouro calcium phosphosilicate, in teeth with dentin hypersensitivity. |