| CTRI Number |
CTRI/2020/05/025235 [Registered on: 19/05/2020] Trial Registered Prospectively |
| Last Modified On: |
06/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing The Clinical Performance Of Activaâ„¢ Bioactive Composite With Microhybrid Composite In Non Carious Cervical Lesions |
|
Scientific Title of Study
|
A One Year Comparative Evaluation Of Clinical Performance Of Activaâ„¢ Bioactive Composite With Microhybrid Composite In Abfraction Lesions: A Randomized Control Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRATHIMA B J |
| Designation |
Post Graduate Student |
| Affiliation |
K.L.E Societys Institute Of Dental Sciences |
| Address |
Room No.6 Department Of Conservative Dentistry And Endodontics
K.L.E Societys Institute Of Dental Sciences
#20 Yeshwanthpur Suburb Tumkur Road
Bengaluru-560022
Bangalore
KARNATAKA
560022
India |
| Phone |
8951201943 |
| Fax |
|
| Email |
prathimabj2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RUPALI KARALE |
| Designation |
Professor and Head |
| Affiliation |
K.L.E Societys Institute Of Dental Sciences |
| Address |
Room No.6 Department Of Conservative Dentistry And Endodontics
K.L.E Societys Institute Of Dental Sciences
#20 Yeshwanthpur Suburb Tumkur Road
Bengaluru-560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9481488247 |
| Fax |
|
| Email |
drkarale79@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRATHIMA B J |
| Designation |
Post Graduate Student |
| Affiliation |
K.L.E Societys Institute Of Dental Sciences |
| Address |
Room No.6 Department Of Conservative Dentistry And Endodontics
K.L.E Societys Institute Of Dental Sciences
#20 Yeshwanthpur Suburb Tumkur Road
Bengaluru-560022
Bangalore
KARNATAKA
560022
India |
| Phone |
8951201943 |
| Fax |
|
| Email |
prathimabj2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No.6 Department Of Conservative Dentistry And Endodontics
K.L.E Societys Institute Of Dental Sciences
#20 Yeshwanthpur Suburb Tumkur Road
Bengaluru-560022
|
|
|
Primary Sponsor
|
| Name |
DR PRATHIMA B J |
| Address |
Room No.6 Department Of Conservative Dentistry And Endodontics
K.L.E Societys Institute Of Dental Sciences
#20 Yeshwanthpur Suburb Tumkur Road
Bengaluru-560022
|
| 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 PRATHIMA B J |
K L E Societys Institute Of Dental Sciences |
Room No.6 Department Of Conservative Dentistry And Endodontics
#20 Yeshwanthpur Suburb Tumkur Road
Bengaluru-560022
Bangalore
KARNATAKA |
8951201943
prathimabj2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ACTIVAâ„¢ bioactive composite |
Placing the restorative material on the abfraction lesions according to the manufacturers instructions after occlusal adjustments followed by recalling the patients at regular intervals
to assess the clinical performance at baseline 1 month 6 months and 12 months intervals |
| Comparator Agent |
FILTEK Z250 MICROHYBRID Composite |
Placing the restorative material on the abfraction lesions according to the manufacturers instructions after occlusal adjustments followed by recalling the patients to assess the clinical performance at regular intervals at baseline 1 month 6 months and 12 months intervals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having isolated abfraction lesions with more than 1 mm depth on the vestibular sides, associated with premolars and molars caused due to abnormal biomechanical loading forces will be selected for the study |
|
| ExclusionCriteria |
| Details |
Poor oral hygiene
Severe or chronic periodontitis
Patients with severe occlusal problems and parafunctional habits
Patients with temporo mandibular joint disorders
Patients who give signs and symptoms of irreversible pulpitis
A known allergic reaction to any of the components of the materials used,
Non-vital, fractured or visibly cracked tooth
Cervical caries
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Two blinded examiners will evaluate the restorations with a mouth mirror and probe at baseline, 1 month, 6 months, and 1 year by modified USPHS criteria which involves Retention, Color Match, Marginal Discoloration, Marginal Adaptation, Secondary Caries, Surface Texture, Anatomic Form, Postoperative Sensitivity and also occlusal interferences will be evaluated using Shim Stock films.
Comparative evaluation of clinical performance of both the composites using modified USPHS criteria |
Two blinded examiners will evaluate the restorations at baseline, 1 month, 6 months, and 1 year by modified USPHS criteria |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patients satisfaction and
satisfactory clinical performance of restorative material in abfraction lesions |
At base line 1month 6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a randomized controlled clinical trial. Verbal and written consent will be obtained from the patients fulfilling the inclusion and exclusion criteria after briefing them about the procedure. Randomization will be done using computer generated tabulation method into Group1 control n 17 Filtek Z250 microhybrid composite restoration Group2 experimental n 17 Activaâ„¢ bioactive composite restoration based on the inclusion and exclusion criteria Clinical procedure Patients who will be selected for this study will be first evaluated for occlusal contacts.The patients who require occlusal corrections will undergo complete occlusal adjustments via selective grinding prior to restoration. After occlusal adjustments are done the same researcher will perform all restorative procedures. For standardization purposes all restorations will be carried out with rubber dam isolation and cleaning of the walls of the tooth to be restored with pumice paste and water. Cavities will be prepared by rounding the internal angles in order to reduce internal stress and all sharp line angles will be smoothened and beveled with a fine bur. Restorative procedure The composite placement will be done according to the manufacturers recommendations .The restorations will be finished and polished using supersnap kit Clinical evaluation Two blinded examiners will evaluate the restorations with a mouth mirror and probe at baseline, 1 month, 6 months, and 1 year by modified USPHS criteria which involves retention, color match, marginal discoloration, marginal adaptation, secondary caries, surface texture, anatomic Form, postoperative sensitivity and also occlusal interferences will be evaluated using shim stock films |