| CTRI Number |
CTRI/2026/02/103499 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare Tooth Sensitivity in Patients After Dental Fillings Using Three Different Filling Materials. |
|
Scientific Title of Study
|
Comparative Evaluation of Postoperative Sensitivity Following Restoration of Class I Cavity with Three Different Restorative Materials: A randomized controlled 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 |
Samidha Chaulliwar |
| Designation |
Postgraduate student |
| Affiliation |
K.B.H. Dental College and Hospital |
| Address |
Samidha Chaulliwar,
502, Dept. of Conservative Dentistry and Endodontics, K.B.H Dental college and hospital, Panchavati, Nashik
Mumbai -Agra highway,Panchavati, Nashik
422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9503918663 |
| Fax |
|
| Email |
samidhachaulliwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenal Guve |
| Designation |
Head of the department |
| Affiliation |
K.B.H. Dental College and Hospital |
| Address |
Dr. Meenal gulve,
502, Dept. of Conservative Dentistry and Endodontics, K.B.H Dental college and hospital, Panchavati, Nashik
Mumbai -Agra highway,Panchavati, Nashik
422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822602043 |
| Fax |
|
| Email |
meenalgulve@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenal Guve |
| Designation |
Head of the department |
| Affiliation |
K.B.H. Dental College and Hospital |
| Address |
Dr. Meenal gulve,
502, Dept. of Conservative Dentistry and Endodontics, K.B.H Dental college and hospital, Panchavati, Nashik
Mumbai -Agra highway,Panchavati, Nashik
422003
MAHARASHTRA
422003
India |
| Phone |
9822602043 |
| Fax |
|
| Email |
meenalgulve@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Samidha Chaulliwar |
| Address |
502, Dept. of Conservative Dentistry and Endodontics, K.B.H Dental college and hospital, Panchvati, Nashik, India - 422003 |
| Type of Sponsor |
Private medical college |
|
|
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 Samidha Chaulliwar |
K.B.H Dental college and hospital |
502, Dept. of Conservative Dentistry and Endodontics, K.B.H Dental college and hospital,Panchavati, Nashik
Nashik
MAHARASHTRA |
9503918663
samidhachaulliwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KBH Dental College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
composite resin with etch and rinse bonding agent, composite resin with self-etch bonding agent and Cention N with adhesive |
To Compare and evaluate Postoperative Sensitivity Following Restoration of Class I Cavity using composite resin with etch and rinse bonding agent, composite resin with self-etch bonding agent and Cention N with adhesive at 24hrs and 1 week. |
| Intervention |
Self etch adhesive |
self etch adhesive followed by composite and self etch adhesive follwed by cention N |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient having age between 18 to 30 years.
2) Systemically healthy and co-operative patients will be selected.
3) Mandibular permanent first and second molar having class I caries with diagnosis of reversible pulpitis.
|
|
| ExclusionCriteria |
| Details |
1) Teeth with prior history of restoration.
2) Patient having developmental anomalies of teeth.
3) Tooth with immature apex, periapical lesion, pathologic mobility and internal or external resorption seen on radiograph.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative sensitivity in 3 groups after 24 hours and 7 days. |
24 hours and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/02/2026 |
| 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="20" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients within the age range of 18-30 years will
be selected. A detailed medical history will be taken from each patient
followed by clinical examination. Radiographic examination will be done to
confirm. Patients will be informed about the details of study procedure and
informed consent form will be obtained from them. Postoperative Sensitivity will be assessed
using VAS from all the patients.
Following rubber
dam application, a class I cavity will be prepared on the occlusal surface of
tooth using round and straight bur in a high-speed handpiece with water spray.
Carious tooth structure will be removed until sound tooth structure will be
detected by tactile examination using dental probe. Before restoration, the
cavity will be checked for any debris, then cleaned and dried. The teeth will
be then restored depending on the restoration group they will be randomly
allotted to.
The subjects will
be randomly divided into three groups of 10 samples each. (n=10)
Groups will be as
follows:-
Group I: Selective enamel
etching of the prepared cavity will be carried out for 15 s with etchant.
Thorough rinsing of the etchant with a water jet followed by gentle drying with
an air jet will be done. Using a disposable applicator tip, the dentin and
enamel surfaces will be covered with a substantial coating of bonding agent.
Excess material will be removed by a gentle stream of air so that adhesive
covers enamel and dentin completely without pooling and light-cured for
20 s. The cavity will be then restored with composite resin followed by
light cured for 20 s.
Group II: A thick layer of
self-etch bonding agent will be applied using disposable applicator tip
10 s. Excess material will be removed by a gentle stream of air so that
adhesive covers enamel and dentin completely without pooling and light-cured
for 20 s. The cavity will be then restored with composite resin followed
by light cured for 20 s.
Group III: Selective enamel
etching of the prepared cavity will be carried out for 15 s with etchant.
Thorough rinsing of the etchant with a water jet followed by gentle drying with
an air jet will be done. Using a disposable applicator tip, the dentin and
enamel surfaces will be covered with a substantial coating of bonding agent.
Excess material will be removed by a gentle stream of air so that adhesive
covers enamel and dentin completely without pooling and light-cured for
20 s. Cention N will be then manipulated and condensed into the cavity
followed by a 20 s light cure.
Patients will be given
postoperative instructions including maintenance of oral hygiene. Patients will
be asked to record any episode of sensitivity if experienced using a 0–10
visual analog scale (VAS scale) and to place a mark anywhere on the horizontal
VAS scale depending on the intensity of pain with 0 indicating “no pain” and 10
indicating “unbearable sensitivity” after 24 hrs and 7 days. |