| CTRI Number |
CTRI/2024/11/077272 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing two treatment protocols in reducing Dentin hypersensitivity |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of two In-office Desensitizing agents in Reducing Dentin hypersensitivity- A Randomised Split Mouth Clinical Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Juttu Shirisha |
| Designation |
MDS |
| Affiliation |
Panineeya Institute of dental sciences and research centre |
| Address |
Panineeya Institute of dental sciences and research centre Room number-6 Department of conservative dentistry and endodontics Road number 5 VR Colony Kamala Nagar Diluskhnagar Hyderabad
Hyderabad TELANGANA 500060 India |
| Phone |
9177311966 |
| Fax |
|
| Email |
shirishaj321@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Umrana Faizuddin |
| Designation |
Professor |
| Affiliation |
Panineeya Institute of dental sciences and research centre |
| Address |
Panineeya Institute of dental sciences and research centre Room number-6 Department of conservative dentistry and endodontics Road number 5 VR Colony Kamala Nagar Diluskhnagar Hyderabad
Hyderabad TELANGANA 500060 India |
| Phone |
9949244418 |
| Fax |
|
| Email |
umranaafroz@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Umrana Faizuddin |
| Designation |
Professor |
| Affiliation |
Panineeya Institute of dental sciences and research centre |
| Address |
Panineeya Institute of dental sciences and research centre Room number-6 Department of conservative dentistry and endodontics Road number 5 VR Colony Kamala Nagar Diluskhnagar Hyderabad
Hyderabad TELANGANA 500060 India |
| Phone |
9949244418 |
| Fax |
|
| Email |
umranaafroz@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Panineeya Institute of dental sciences and research centre Room number-6 Department of conservative dentistry and endodontics Road number 5 VR Colony Kamala Nagar Diluskhnagar Hyderabad |
|
|
Primary Sponsor
|
| Name |
Dr Juttu Shirisha |
| Address |
Panineeya Institute of dental sciences and research centre Room number-6 Department of conservative dentistry and endodontics Road number 5 VR Colony Kamala Nagar Diluskhnagar Hyderabad
|
| Type of Sponsor |
Other [self] |
|
|
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 Juttu Shirisha |
Panineeya Institute of Dental Sciences and Research Centre |
Panineeya Institute of dental sciences and research centre Room number-6 Department of conservative dentistry and endodontics Road number 5 VR Colony Kamala Nagar Diluskhnagar Hyderabad
Hyderabad TELANGANA |
9177311966
shirishaj321@gmail.com |
|
|
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 |
cervical abrasion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Resin based varnish |
single coat applied on the buccal side of the cervical area of the teeth and light cured for 15 seconds |
| Comparator Agent |
sodium fluoride based Varnish |
Applied on the buccal surface of teeth and left for initial set for 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients from 30 to 60 years of age with excellent systemic health conditions with history of dentin hypersensitivity with Preoperative Schiff scale of ≥1 and at least two or more lesions in two different quadrants of the mouth are included in this study
|
|
| ExclusionCriteria |
| Details |
Patients who have used desensitizing toothpaste in the last 3 months, receiving periodontal therapy with cervical defects greater than 2mm horizontally, allergic to ingredients used in the study, chronic users of anti-inflammatory and analgesics, pregnant or nursing with uncontrolled systemic diseases, with fractured or cracked teeth are excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of varnishes |
baseline score, immediately, after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of varnishes |
after 1 month |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2024 |
| 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="3" 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
|
Dentin hypersensitivity is a painful sensation commonly reported in daily practice.It is defined as a short, sharp pain that arises from exposed dentin in response to non-noxious stimuli, typically thermal, evaporative, tactile, osmotic or chemical, and that cannot be ascribed to any other form of dental defects or diseases. The frequency of Dentin hypersensitivity increases with age; the majority of patients affected by Dentin hypersensitivity are between their second and fifth decades of life, with top events extending from 30 to 40 years of age. Females are more likely to be affected. The condition generally involves the facial surfaces of teeth at the cervical aspect and is very common in premolars and canines. The treatments for dentin sensitivity include professional in-office, at-home or over-the-counter desensitizing agents. Application of desensitizing agents is the most frequently used non-invasive treatment for Dentin hypersensitivity, especially in cases with limited or invisible dental hard tissue loss or cervical exposure. The active compounds found in desensitization products could either block the openings of dentinal tubules thereby isolating the tubule contents or might directly desensitize the pulpal nerves. In-office topical application of desensitizing agents used earlier worked by tubular occlusion. Nowadays, newer agents having remineralization properties and superior bond strength came into existence. Shield Force Plus (resin-based) and MI varnish (sodium fluoride-based) are such desensitizing agents. Shield Force Plus, a one component self-etching light-cured dental adhesive based on Self Reinforcement technology, characterized by an Self Reinforcing monomer component that penetrates into the tooth substrate resulting in multi-point interactions with apatite calcium, and three-dimensional cross-linking reactions. It forms a thin, and uniform hard coating on the tooth surface for superior bond strength to the tooth substance. MI varnish, which is used for in�’office treatment, acts by plugging the dentinal tubules and is a calcium phosphate�’based varnish. It is a 5% sodium fluoride�’based varnish with phosphopeptides (CPP) which stabilizes the amorphous calcium phosphate phase to deliver the bioavailable calcium, phosphate, and fluoride ions to the tooth surface to promote remineralization of the tooth structure. The aim of this study is to assess the effectiveness of two in-office desensitizing agents in reducing dentinal hypersensitivity in patients with mild-to-moderate sensitivity with a 1-month follow-up. |