| CTRI Number |
CTRI/2025/03/082613 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Post-Operative Sensitivity and Marginal Integrity in Permanent Back Teeth Restored with Composite Resin Using Total-Etch and One-Step Universal Adhesive Systems: A Randomized Controlled Trial Involving Adult Participants |
|
Scientific Title of Study
|
A COMPARISON OF POST-
OPERATIVE HYPERSENSITIVITY AND MARGINAL INTEGRITY OF
COMPOSITE RESIN RESTORATIONS IN PERMANENT POSTERIOR
TEETH USING TOTAL-ETCH AND ONE-STEP UNIVERSAL ADHESIVE
SYSTEM: 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 |
Dr Shruti |
| Designation |
Postgraduate Student |
| Affiliation |
Himachal Dental College and Hospital, Sundernagar |
| Address |
Department of Conservative Dentistry and Endodontics , Himachal Dental College and Hospital, Sundernagar
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
8396845060 |
| Fax |
|
| Email |
Shrutibharti043@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Verma |
| Designation |
Professor |
| Affiliation |
Himachal Dental College and Hospital, Sundernagar |
| Address |
Department of Conservative Dentistry and Endodontics , Himachal Dental College and Hospital, Sundernagar
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
9418476681 |
| Fax |
|
| Email |
drshwetaverma053@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Verma |
| Designation |
Professor |
| Affiliation |
Himachal Dental College and Hospital, Sundernagar |
| Address |
Department of Conservative Dentistry and Endodontics , Himachal Dental College and Hospital, Sundernagar
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
9418476681 |
| Fax |
|
| Email |
drshwetaverma053@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himachal Dental College and hospital,Sundernagar,
Himachal Pradesh 175018 |
|
|
Primary Sponsor
|
| Name |
Dr Shruti |
| Address |
Department of Conservative Dentistry and Endodontics , Himachal Dental College and Hospital, Sundernagar |
| 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 Shruti |
Himachal Dental College and Hospital, Sundernagar |
Department of Conservative Dentistry and Endodontics , Himachal Dental College and Hospital, Sundernagar
Mandi
HIMACHAL PRADESH |
8396845060
Shrutibharti043@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Himachal dental college Sundernagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
One Step Universal Adhesi system |
The one-step universal adhesive system is a simplified bonding technique that combines etching, priming, and bonding in a single application. It can be used in self-etch, total-etch, or selective-etch modes, offering versatility and reducing post-operative sensitivity. This system is user-friendly and provides reliable adhesion with minimal steps. |
| Comparator Agent |
Total Etch Adhesive System (5th generation) |
The total-etch adhesive system is a technique in which phosphoric acid is used to etch both enamel and dentin before applying the adhesive. This method enhances bond strength by creating a strong micromechanical retention but may increase post-operative sensitivity due to dentin demineralization. It is widely used for composite resin restorations, especially in cases requiring high durability. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-45 years.
2. No previous sensitivity to hot/cold.
3. Good oral hygiene.
4. Patients with at least 2 carious posterior teeth with class I caries extended to
dentin (ICDAS 4) not more than one-half the distance between pulp and
Dentino-enamel junction (DEJ).
5. A periodontally sound and asymptomatic vital tooth.
6. Patient who are able to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1. Deep carious lesion extending near pulp.
2. Uncontrolled Diabetes.
3. Parafunctional Habits such as Bruxism, Clenching of teeth.
4. Abnormal occlusion.
5. Teeth with increased pre-operative sensitivity.
6. Subject receiving desensitizing therapy.
7. Non-vital teeth with pulp necrosis or irreversible pulpitis. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post Operative Sensitivity will be evaluated based upon VAS |
24 hours, 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marginal adaptation and Discoloration |
3 months , 6 months |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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 3 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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="1"
Months="7"
Days="30" |
|
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
|
This Randomized Controlled Trial (RCT) enrolled patients meeting specific eligibility criteria, requiring at least two Class I carious lesions (ICDAS 4) extending to dentin but not exceeding half the distance to the DEJ.
Patients were randomly assigned to two groups: Group A: Total-Etch Adhesive System (5th Generation) Group B: One-Step Universal Adhesive System (8th Generation)
All cavities were restored using nanohybrid composite resin with the incremental technique, followed by finishing and polishing.
Evaluation Parameters: Post-operative hypersensitivity assessed using VAS immediately, at 24 hours, and 7 days post-procedure. Marginal discoloration and adaptation evaluated at 3 and 6 months using USPHS criteria.
All data collected will undergo statistical analysis to compare the effectiveness of both adhesive systems.
|