| CTRI Number |
CTRI/2022/06/043497 [Registered on: 27/06/2022] Trial Registered Prospectively |
| Last Modified On: |
23/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Dentistry |
| Study Design |
Other |
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Public Title of Study
|
Evaluation of Desensitizing Effects of 10% Potassium Nitrate and Gluma Primer in Treating Dentinal Hypersensitivity. |
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Scientific Title of Study
|
Evaluation of Desensitizing Effects of 10% Potassium Nitrate and Gluma Primer in Treating Dentinal Hypersensitivity- A Split Mouth, Double Blind, Preliminary Randomized Control Trial.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V S VISHNU |
| Designation |
Post graduate student, Dept of Periodontics |
| Affiliation |
Sri Hasanamba Dental College and Hospital |
| Address |
Room no 5, Department of Periodontics, Sri Hasanamba Dental College and Hospital, Vidyanagar Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9738107177 |
| Fax |
|
| Email |
vishnugowda17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivekananda M R |
| Designation |
Professor |
| Affiliation |
Sri Hasanamba Dental College and Hospital |
| Address |
Room no 5, Department of Periodontics, Sri Hasanamba Dental College and Hospital, Vidyanagar Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9980843531 |
| Fax |
|
| Email |
vivekcodsperio@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V S VISHNU |
| Designation |
Post graduate student, Dept of Periodontics |
| Affiliation |
Sri Hasanamba Dental College and Hospital |
| Address |
Room no 5, Department of Periodontics, Sri Hasanamba Dental College and Hospital, Vidyanagar Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9738107177 |
| Fax |
|
| Email |
vishnugowda17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 5, Department of Periodontics, Sri Hasanamba Dental College and Hospital, Vidyanagar, Hassan |
|
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Primary Sponsor
|
| Name |
Sri Hasanamba Dental College |
| Address |
Room no 5, Department of Periodontics, Sri Hasanamba Dental College and Hospital, Vidyanagar, Hassan. 573201 |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V S Vishnu |
Sri Hasanamba Dental College and Hospital |
Room no 5, Department of Periodontics.
Hassan
KARNATAKA |
9738107177
vishnugowda17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dentinal Hypersensitivity |
| Patients |
(1) ICD-10 Condition: K030||Excessive attrition of teeth, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
10% Potassium Nitrate |
Evaluation of Desensitizing effects of 10% Potassium Nitrate. Application of this agent on hypersensitive teeth using applicator tip at weekly intervals for 4 weeks. |
| Comparator Agent |
Gluma Primer |
Evaluation of Desensitizing effects of Gluma Primer in treating dentinal hypersensitivity. Application of this agent on hypersensitive teeth using applicator tip at weekly intervals for 4 weeks. |
|
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. History of hypersensitivity
2. No other treatments received for hypersensitivity, at least 2 months prior to this trial.
3. Clinical evaluation of exposed occlusal dentine bilaterally I,e., attrition.
4. Patients with 35-70 years age groups.
5. Home care oral hygiene instructions standardized.
|
|
| ExclusionCriteria |
| Details |
1. Caries or restoration in relation to hypersensitive teeth.
2. Enamel cracks or pulpitis.
3. Cervical abrasions and erosions.
4. History of periodontal surgeries within past 6 months.
5. Using desensitizing tooth paste.
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in clinical signs and symptoms of dentine hypersensitivity. |
Weekly intervals i.e, 1st week, 2nd week, 3rd week, 4th week and 5th week. |
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Secondary Outcome
|
| Outcome |
TimePoints |
| Compare desensitising effects of 10% potassium nitrate and Gluma® primer in treating dentinal hypersensitivity. |
5 weeks |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
07/10/2022 |
| 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="0"
Months="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - rct
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vvgf@gmail.com].
- For how long will this data be available start date provided 03-08-2022 and end date provided 02-01-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - www.hassandental.co.in
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Brief Summary
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Potassium nitrate was introduced as a desensitizing agent. Potassium nitrate is supposed to reduce hypersensitivity by inducing a sustained depolarization of nerve membrane. It has also been postulated that blockage of dentinal tubules by potassium nitrate reduces sensitivity.
Gluma® is a commercially available desensitizing agent which is known to occludes dentinal tubules by coagulation of amino acids and proteins present in the dentin. There are no studies evaluating the desensitizing effects of 10% potassium nitrate compared to gluma primer. The present study aims to compare and evaluate their effectiveness in the treatment of dentine hypersensitivity.
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