| CTRI Number |
CTRI/2025/04/084958 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2025 |
| 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 in non-carious cervical lesions restored with composite and cured with 2 curing modes of LED |
|
Scientific Title of Study
|
Comparative evaluation of postoperative sensitivity in non-carious cervical lesions restored with composite using step curing vs continuous curing modes of LED: A split-mouth randomised 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 Pooja Shah |
| Designation |
PG STUDENT |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
Room no 302 3rd floor, Department of Conservative Dentistry and
Endodontics Bharati Vidyapeeth Dental College and Hospital,
Sector 7 CBD Belapur Navi Mumbai 400614
Mumbai
MAHARASHTRA
400614
India
Mumbai MAHARASHTRA 400614 India |
| Phone |
7588110013 |
| Fax |
|
| Email |
poojashah222.ps@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amit Patil |
| Designation |
Associate professor |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
Room no 302, 3rd floor, Department of Conservative Dentistry and
Endodontics, Bharati Vidyapeeth Dental College and Hospital,
Sector 7, CBD Belapur, Navi Mumbai 400614
Mumbai
MAHARASHTRA
400614
India
Mumbai MAHARASHTRA 400614 India |
| Phone |
09423903812 |
| Fax |
|
| Email |
amithpatil85@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pooja Shah |
| Designation |
PG STUDENT |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
Room no 302, 3rd floor, Department of Conservative Dentistry and
Endodontics, Bharati Vidyapeeth Dental College and Hospital,
Sector 7, CBD Belapur, Navi Mumbai 400614
Mumbai
MAHARASHTRA
400614
India
Mumbai MAHARASHTRA 400614 India |
| Phone |
07588110013 |
| Fax |
|
| Email |
poojashah222.ps@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Pooja Shah Room no 302, 3rd floor, Bharati vidyapeeth dental college and hospital, sector 7, CBD belapur, Navi mumbai 400614 |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Shah |
| Address |
Department of Conservative Dentistry and Endodontics, Bharati
Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur,
Navi Mumbai 400614
|
| 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 Pooja Shah |
Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai |
Room no 302, 3rd floor
Department of
Conservative Dentistry
and Endodontics,
Bharati Vidyapeeth
Dental College and
Hospital, Sector 7, CBD
Belapur, Navi Mumbai
400614
Mumbai
MAHARASHTRA Mumbai MAHARASHTRA |
7588110013
poojashah222.ps@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K031||Abrasion of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
continuous curing |
G-aenial Flo will be applied to surface roughened NCCLs and cured with continuous (constant) curing mode of led for 20 seconds |
| Intervention |
Step curing |
G-aenial Flo will be applied to surface roughened NCCLs and cured with step curing (soft start polymerisation) mode of led |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cooperative, healthy subjects who are willing to participate in the study and sign the consent form.
Selected subjects must be at least 18 years old and of either sex.
Subjects having NCCLs involving enamel and dentin.
Subjects having at least two contra lateral teeth with Non carious cervical lesion.
Vital teeth giving a positive response to cold test.
|
|
| ExclusionCriteria |
| Details |
Subjects unwilling to sign the consent form.
Teeth with carious lesions.
Subjects with teeth having lesions more than 2 mm in depth.
NCCLs extending below the cemento-enamel junction.
Patients using desensitizing agents regularly.
Teeth with spontaneous, severe or continuous pain and existing sensitivity.
Patients with any irreversible pulpal, periodontal and periapical pathology.
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative sensitivity scores |
Post operative sensitivity scores at 24 hours, 7 days and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
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)
|
20/04/2025 |
| 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 - NO
|
|
Brief Summary
|
Post-operative sensitivity after composite restoration remains a challenge and in most studies postoperative sensitivity was found to be up to onethird of the study sample· Non carious cervical lesions [NCCL] cause loss of dental hard tissue in the cervical part of the tooth exposing the dentinal tubules to the oral environment. · Thus, when the affected tooth is exposed to heat or stimuli, it results in expansion and contraction of dentinal fluids in the gap formed, which causes fluid movement in the dentinal tubules leading to postoperative sensitivity. · Flowable resins tend to absorb the stresses created during polymerization shrinkage. G-aenial Universal Flow, a flowable resin tends to exhibit lower polymerization shrinkage stress of about 1.3 MPa, which leads to lesser postoperative sensitivity.· It is claimed that soft start polymerization technique reduces polymerization shrinkage sequentially reducing microgaps, microleakage, and postoperative sensitivity. Thus we have undertaken this study comparing postoperative sensitivity using G-aenial Universal Flo with step curing and continuous curing technique in NCCL · Hence this study will highlight if step curing is a better treatment modality than continuous curing in reducing postoperative sensitivity in NCCL, so that a better technique can be adopted in subsequent patients. |