| CTRI Number |
CTRI/2023/07/055379 [Registered on: 19/07/2023] Trial Registered Prospectively |
| Last Modified On: |
11/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of postoperative senstivity of preheating thermoviscous composite in noncarious cervical lesions |
|
Scientific Title of Study
|
Evaluation of postoperative senstivity of preheating thermoviscous composite for restoration of noncarious cervical lesions: A split mouth design invivo 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 |
Bhashitha Chirikella |
| Designation |
postgraduate |
| Affiliation |
Drs.sudha and nageswararao siddhartha institute of dental sciences |
| Address |
Drs Sudha and Nageswararao Siddhartha institute of dental sciences,
chinoutpalli
gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
7013608602 |
| Fax |
|
| Email |
sairamya3398@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Ramesh |
| Designation |
Professor |
| Affiliation |
Drs.sudha and nageswararao siddhartha institute of dental sciences |
| Address |
Drs Sudha and Nageswararao Siddhartha institute of dental sciences,
chinoutpalli
gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9441060175 |
| Fax |
|
| Email |
ramesh51endo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Ramesh |
| Designation |
Professor |
| Affiliation |
Drs.sudha and nageswararao siddhartha institute of dental sciences |
| Address |
Drs Sudha and Nageswararao Siddhartha institute of dental sciences,
chinoutpalli
gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9441060175 |
| Fax |
|
| Email |
ramesh51endo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Drs Sudha and Nageswararao Siddhartha institute of dental sciences,
chinoutpalli
gannavaram mandal
vijayawada - 521286 |
|
|
Primary Sponsor
|
| Name |
BHASHITHA CHIRIKELLA |
| Address |
Drs Sudha and Nageswararao Siddhartha institute of dental sciences,
chinoutpalli
gannavaram mandal
krishna district
Andhrapradesh- 521286 |
| Type of Sponsor |
Other [myself] |
|
|
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 |
| bhashitha chirirkella |
Drs.sudha and nageswararao siddhartha institute of dental sciences |
department of conservative dentistry and endodntics, gannavaram mandal.
521286
Krishna
ANDHRA PRADESH |
7013608602
sairamya3398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
non carious cervical lesions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NONHEATED NEOSPECTRA ST COMPOSITE |
RESTORATIVE MATERIAL EVALUATION FOR A WEEK |
| Intervention |
PREHEATED NEOSPECTRA ST COMPOSITE AT 68 DEGREES |
RESTORATIVE MATERIAL EVALUATION FOR A WEEK |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
40 patients with Sensitive wedge/ saucer shaped
cervical lesions in posterior teeth
Healthy periodontal status
Vital teeth
|
|
| ExclusionCriteria |
| Details |
Xerostomia
Analgesic/antibiotic usage
DMFT more than 12
Poor oral hygiene
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative senstivity |
one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical post operative sensitivity |
one week |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/07/2023 |
| 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="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
|
In this study, we will evaluate the post operative senstivity in non carious cervical lesions using preheated composite and room temperature composite for a week period. The number of patients taken is 20 per eachgroup. |