| CTRI Number |
CTRI/2024/11/076881 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To Evaluate and Compare One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin clinically using USPHS criteria and after artificial ageing - A Two year Study |
|
Scientific Title of Study
|
Comparative evaluation of clinical performance of One shade Universal Composite and Universal Nanohybrid Composite in non carious cervical lesions and after artificial ageing - A two year randomised clinical 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 |
Pradnya V Bansode Wadikar |
| Designation |
Prof and Head of Department Conservative Dentistry and Endodontics Chhatrapati Sambhajinagar |
| Affiliation |
Govt Dental College And Hospital Chhatrapati Sambhajinagar |
| Address |
Department of Conservative Dentistry and Endodontics
Government Dental College and Hospital Chhatrapati Sambhajinagar
Aurangabad MAHARASHTRA 431001 India |
| Phone |
8308263792 |
| Fax |
|
| Email |
pradnyawadikar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Pradnya V Bansode Wadikar |
| Designation |
Prof and Head of Department Conservative Dentistry and Endodontics Chhatrapati Sambhajinagar |
| Affiliation |
Govt Dental College And Hospital Chhatrapati Sambhajinagar |
| Address |
Department of Conservative Dentistry and Endodontics
Government Dental College and Hospital Chhatrapati Sambhajinagar Dr. Sadashiv Daokar, Dr. Sumanthini M
Professor and HOD, CSMSS Dental College and Hospital, Chhatrapati Sambhajinagar Aurangabad MAHARASHTRA 431001 India |
| Phone |
8308263792 |
| Fax |
|
| Email |
pradnyawadikar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Pradnya V Bansode Wadikar |
| Designation |
Prof and Head of Department Conservative Dentistry and Endodontics Chhatrapati Sambhajinagar |
| Affiliation |
Govt Dental College And Hospital Chhatrapati Sambhajinagar |
| Address |
Department of Conservative Dentistry and Endodontics
Government Dental College and Hospital Chhatrapati Sambhajinagar
Aurangabad MAHARASHTRA 431001 India |
| Phone |
8308263792 |
| Fax |
|
| Email |
pradnyawadikar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pradnya V Bansode |
| Address |
Department of Consevative Dentistry and Endodontics Government Dental College and Hospital Chhatrapati Sambhajinagar |
| Type of Sponsor |
Other [Self financed] |
|
|
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 |
| DrPradnya V Bansode Wadikar |
Government Dental College and Hospital Chh.Sambhaji nagar |
Department of Conservative Dentistry and Endodontics,
Government Dental College and Hospital, Chhatrapati Sambhajinagar. Aurangabad MAHARASHTRA |
8308263792
pradnyawadikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt. Dental College & Hospital Aurangabad (Chh.Sambhaji Nagar) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients having atleast two noncarioussmall and shallow cervical abrasions with atleast 1mm depth in Maxillary Premolars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To evaluate and compare Omnichroma (One shade Universal Composite) and Fusion (Universal Nanohybrid Composite) in-vivo using modified USPHS Criteria and after artificial ageing in vitro at the end of two years. |
Long term clinical evaluation between Omnichroma (One shade Universal Composite) and Fusion (Universal Nanohybrid Composite) will be done. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)patients with atleast two non carious small and shallow cervical abrasions in maxillary premolars.
2)Good Oral Hygiene.
3) Patients willing to participate in the study and co-operate during the study tenure. |
|
| ExclusionCriteria |
| Details |
(a) Poor oral hygiene
(b) Severe or active periodontal disease.
(c) Caries and lack of compliance.
(d) Non vital teeth
(e) Fractured or visibly cracked teeth
(1) Patient will be excluded if the patient withdraws or opts out of study before 12 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparative evaluation of One Shade Universal Composite resin and Universal Nanohybrid composite resin using digital VITA Shade Guide & modified USPHS criterion to evaluate -
1) marginal discoloration
2) marginal integrity
3) surface texture
4) wear
5) postoperative sensitivity
6) recurrent caries
|
Baseline, 6 months, 12 months, 18 months, 24 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Invitro Comparative evaluation of One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin after preparation of 80 resin discs each of both the materials. Shade, surface roughness and microhardness will be evaluated and compared |
Thermocycling of composite resin discs will be done to create artificial ageing. Values will be recorded at baseline, 12 months and 24 months. |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
24/11/2024 |
| 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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
This study involves Invivo and Invitro comparative evaluation of One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin. 80 patients of age group 18 years - 35 years having non carious cervical lesions in atleast two maxillary premolars will be selected for the study after obtaining their informed consent in writing. After preparation of standardised class V cavities at the cervical lesions the two composite resins will be used to restore the same using standardised protocol and as per manufacturers instructions. Clinical evaluation One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin will be done using Digital VITA Shade Guide and using the USPHS Criteria to evaluate marginal discolouration, marginal integrity, surface texture, wear, post operative sensitivity and recurrent caries. The findings will be recorded at baseline, 6 months, 12 months, 18 months and 24 months. There will be blinding of the evaluators who will be evaluating the restorations at the said intervals. The Invitro part of the study involves preparation of 80 discs each of One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin having 8 mm diameter and 2 mm depth. All the discs will be subjected to artificial ageing by following the thermocycling protocol for 2 years. Evaluation for shade, surface roughness and microhardness will be done at baseline, 12 months and 24 months. The values will be recorded and saved for statistical analysis. This study is unique as there will be long term clinical evaluation between One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin and also invitro laboratory comparative evaluation of the disc specimens of the said materials will be carried out. |