| CTRI Number |
CTRI/2023/08/056788 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
21/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of postoperative sensitivity after cavity filling with two different filling materials. |
|
Scientific Title of Study
|
Comparison of postoperative sensitivity of Bulk Fill composite using a two step technique with incrementally layered Nanocomposite in class 1 cavities and selective etch method: A Randomized Controlled Single Blind 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 Shivani Waje |
| Designation |
PG Student |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai
Thane
MAHARASHTRA
400614
India |
| Phone |
9403243548 |
| Fax |
|
| Email |
shivaniwaje@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Jain |
| Designation |
Head of Department |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai
Thane
MAHARASHTRA
400614
India |
| Phone |
9869152905 |
| Fax |
|
| Email |
drakjain5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Waje |
| Designation |
PG Student |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai
Thane
MAHARASHTRA
400614
India |
| Phone |
9403243548 |
| Fax |
|
| Email |
shivaniwaje@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr. Shivani Waje |
| Address |
Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital. Sector 7, CBD Belapur, Navi Mumbai |
| 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 Shivani Waje |
Bharati Vidyapeeth Dental College and Hospital Navi Mumbai |
302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai, 400614.
Thane
MAHARASHTRA |
9403243548
shivaniwaje@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical 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 |
| Intervention |
Bulk fill composite |
After selective etching and application of bonding agent, 3M Filtek bulk fill flowable composite will be placed in the cavity in 1 single layer to replace dentin and cured for 20 seconds, this will be followed by 3M Filtek bulk fill posterior which will allow for final occlusal sculpting. This will be cured for 20 seconds. |
| Comparator Agent |
Nanocomposite |
After selective etching and application of bonding agent, 3M nano fill flowable composite will be placed to provide Immediate Dentin Sealing (IDS) and cured for 20 seconds. Then two oblique increments of 3M Filtek Z350XT A3 body shade will be placed contacting only 2 surfaces of the cavity to replace dentin and cured for 20 seconds after each increment. After this, 3M Filtek Z350XT A2 enamel shade will be individually applied for each cusp and cured for 20 seconds. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Cooperative, healthy subjects who are willing to participate in the study and sign the consent form.
Molars and premolars requiring Class 1 composite resin restorations for the treatment of primary carious lesions.
Carious lesions involving enamel and dentin [ICDAS score 3, 4 &5] clinically and radiographically [ICDAS score RA2, RA3 & RB4].
Asymptomatic patient or patient having symptomatic reversible pulpitis.
The selected teeth should have occlusal contacts with natural or crowned antagonist teeth.
Vital teeth giving a positive response to cold test.
|
|
| ExclusionCriteria |
| Details |
Subjects unwilling to sign the consent form.
Teeth with deep carious lesions approaching the pulp.
Patients having old restorations.
Teeth with spontaneous, severe or continuous pain.
Patients with any irreversible pulpal, periodontal and periapical pathology.
Patients with painful temporomandibular joint problems.
Patients taking analgesics and anti-inflammatory drugs during past 3 days.
Patients having known allergy to resin-based material.
Patients having bruxism.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative sensitivity scores |
Postoperative sensitivity scores at 24 hours 48 hours & 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of depth of cavity on postoperative sensitivity |
After 24 hours 48 hours & 7 days |
|
|
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)
|
01/09/2023 |
| 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="5"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shivaniwaje@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Restorative dentistry deals with the treatment of tooth defects and restores the function without compromising the biology. Poor adaptation can lead to postoperative sensitivity and failure of restoration. There are problems associated with using resin composite in posterior restorations, most important of which is shrinkage that occurs on setting, and causes postoperative sensitivity. Incremental filling technique reduces polymerization shrinkage by reducing the C-factor, but it has some drawbacks, like incorporation of voids between layers or contamination. These drawbacks have led some manufacturers to introduce composite resins for bulk filling techniques. The bulk fill composite resins have low volumetric shrinkage, but studies have reported that placement of thick increments may increase the stress at the adhesive interface, which may increase postoperative sensitivity. Studies have however reported that the filling technique has no influence on polymerization shrinkage at adhesive interface. Despite the presence of various placement techniques and developments in the technology of resin composites clinical failures of composite restorations are still present. To the best of our knowledge, incidence of postoperative sensitivity using 3M Filtek Z350XT Nanofill composite and 3M Filtek Bulk fill composite has not been evaluated yet. Hence this study is designed to compare and evaluate the postoperative sensitivity of Nanocomposite [3M Z350XT] using incremental layering technique and Bulk fill composite [3M Bulk fill] using a 2 step technique in class 1 cavities. |