| CTRI Number |
CTRI/2024/11/077231 [Registered on: 22/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Desensitizing ability of different desensitizing agents |
|
Scientific Title of Study
|
Desensitizing ability of different desensitizing agents-An in-vivo study |
| 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 Sheba rani katikala |
| Designation |
pg student |
| Affiliation |
Dr ntruhs vijayawada |
| Address |
Department of Conservative Dentistry and Endodontics, St. Joseph Dental College & Hospital, Duggirala, Eluru.
West Godavari ANDHRA PRADESH 534003 India |
| Phone |
7093271897 |
| Fax |
|
| Email |
drshebakatikala406@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Srihari devalla. |
| Designation |
Professor |
| Affiliation |
St. Joseph Dental College & Hospital, Duggirala, Eluru |
| Address |
Department of Conservative Dentistry and Endodontics, St. Joseph Dental College & Hospital, Duggirala, Eluru.
West Godavari ANDHRA PRADESH 534003 India |
| Phone |
9440134678 |
| Fax |
|
| Email |
drsriharidevalla@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Srihari devalla. |
| Designation |
Professor |
| Affiliation |
St. Joseph Dental College & Hospital, Duggirala, Eluru |
| Address |
Department of Conservative Dentistry and Endodontics, St. Joseph Dental College & Hospital, Duggirala, Eluru.
ANDHRA PRADESH 534003 India |
| Phone |
9440134678 |
| Fax |
|
| Email |
drsriharidevalla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, St. Joseph Dental College & Hospital, Duggirala, Eluru. |
|
|
Primary Sponsor
|
| Name |
Sheba rani katikala |
| Address |
Department of Conservative Dentistry and Endodontics, St. Joseph Dental College & Hospital, Duggirala, Eluru. |
| 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 Sheba rani katikala |
St. Joseph Dental College & Hospital |
Department of Conservative Dentistry and Endodontics- 2nd floor, room no 5 West Godavari ANDHRA PRADESH |
7093271897
drshebakatikala406@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ST JOSEPH DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K030||Excessive attrition of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control (no treatment) |
comparision of desensitizing ablity of nanohydroxy apatite gel, curodont and gluma with control (no treatment) |
| Intervention |
nanohydroxy apatite gel, curodont and gluma |
comparision of desensitizing ablity of nanohydroxy apatite gel, curodont and gluma using visual analogue scale score for a period of 3 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants included in the study had the following conditions:
1.Good general health without any known allergy to commercial dental products.
2.The teeth are free of decay or restoration.
3.Patients have not previously received any dentine hypersensitivity treatments.
4.Patients have no history of receiving any teeth whitening treatments.
5.The degree of tooth initial sensitivity should be 3 or higher based on VAS.
|
|
| ExclusionCriteria |
| Details |
Participants excluded from the study had the following conditions:
1.use of medications that could interfere with the perception of pain including chronic
use of anti-inflammatory, analgesic, anticonvulsant, sedative, or other psychotropic drugs;
and pregnancy or breastfeeding and patients with chronic diseases.
2.Patients who have been using desensitizing toothpaste or mouthwash in the last 3 months.
3.Patients who had underwent periodontal surgery in the last 6 months.
4.Teeth with evidence of pulpitis, Vital or non-vital teeth that have cracks, previous large restorations, deep abrasions requiring Class V fillings, or had any fractured or endodontically treated teeth carious lesions, gingival recession of more than 3 mm or active periodontal disease.
5.Teeth with deep carious lesions in the vicinity of sensitive teeth that their pain can be confused with tooth sensitivity.
6.Patients whose sensitive teeth are adjacent together.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation and comparison of desensitizing ability of nanohydroxyapatite, curodont, and gluma. |
1 year |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="71" Sample Size from India="71"
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)
|
04/12/2024 |
| 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="1" Months="0" 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 aim of the study is to evaluate the desensitizing ability of nano-hydroxyapatite based curodont and gluma -in vivo and to compare the desensitizing efficacy of nano-hydroxyapatite based, curodent and gluma. patients will be taken from OPD of department of Conservative Dentistry and Endodontics in St. Joseph Dental College, Eluru. Signed informed consent will be taken from all the patients who are diagnosed with dentinal hypersensitivity. Participants included in the study had the following conditions: 1. Good general health without any known allergy to commercial dental products. 2. The teeth are free of decay or restoration. 3. Patients have not previously received any dentine hypersensitivity treatments. 4. Patients have no history of receiving any teeth whitening treatments. 5. The degree of tooth initial sensitivity should be 3 or higher based on VAS. Participants excluded from the study had the following conditions: 1. use of medications that could interfere with the perception of pain including chronic use of anti-inflammatory, analgesic, anticonvulsant, sedative, or other psychotropic drugs and pregnancy or breastfeeding and patients with chronic diseases. 2. Patients who have been using desensitizing toothpaste or mouthwash in the last 3 months. 3. Patients who had underwent periodontal surgery in the last 6 months. 4. Teeth with evidence of pulpitis, Vital or non-vital teeth that have cracks, previous large restorations, deep abrasions requiring Class V fillings, or had any fractured or endodontically treated teeth carious lesions, gingival recession of more than 3 mm or active periodontal disease. 5. Teeth with deep carious lesions in the vicinity of sensitive teeth that their pain can be confused with tooth sensitivity. 6. Patients whose sensitive teeth are adjacent together.
After recording the initial tooth sensitivity, the patients were randomly divided and intervened with following desensitizing agents i.e, nanohydroxyapatite gel, curodont, and gluma and will be followed up for a period of 3 months. the results will be statistically analyzed. |