| CTRI Number |
CTRI/2017/12/010787 [Registered on: 06/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
03/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bioactive materials - a boon in Dentistry |
|
Scientific Title of Study
|
A comparative clinical evaluation of a Bioactive and Microfill composite resins in non carious cervical lesions- 12 months results. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mona Yadav |
| Designation |
Post Graduate Resident |
| Affiliation |
Army College of Dental Sciences |
| Address |
Army College of Dental Sciences, Department of Conservative Dentistry and Endodontics, Room no 9,
Jai Jawahar Nagar, CRPF Road, Secunderabad
Army College of Dental Sciences,
Jai Jawahar Nagar, CRPF Road, Secunderabad
Rangareddi
ANDHRA PRADESH
500087
India |
| Phone |
7032509343 |
| Fax |
|
| Email |
monayadav91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mona Yadav |
| Designation |
Post Graduate Resident |
| Affiliation |
Army College of Dental Sciences |
| Address |
Army College of Dental Sciences, Department of Conservative Dentistry and Endodontics, Room no 9,
Jai Jawahar Nagar, CRPF Road, Secunderabad
Army College of Dental Sciences,
Jai Jawahar Nagar, CRPF Road, Secunderabad
Rangareddi
ANDHRA PRADESH
500087
India |
| Phone |
7032509343 |
| Fax |
|
| Email |
monayadav91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Kaushik |
| Designation |
Professor and Head |
| Affiliation |
Army College of Dental Sciences |
| Address |
Army College of Dental Sciences, Department of Conservative Dentistry and Endodontics, Room no 9
Jai Jawahar Nagar, CRPF Road, Secunderabad
Rangareddi
ANDHRA PRADESH
500087
India |
| Phone |
9391010325 |
| Fax |
|
| Email |
mamkaushik@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Mona Yadav |
| Address |
Army College of Dental Sciences,
Jai Jawahar Nagar, CRPF Road, Secunderabad - 500087 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Mona Yadav |
Army College of Dental Sciences |
Department of Conservative Dentistry & Endodontics,Army College of Dental Sciences,
Jai Jawahar Nagar, CRPF Road, Secunderabad
Rangareddi
ANDHRA PRADESH |
7032509343
monayadav91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Army College of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
1. Presence of at least two NCCL’s with equal depth (1-2 mm)
2. Patients of age ranging from 20 to 60 years
3. Vital teeth
5. Presence of occlusion and proximal contact with adjacent teeth
, (1) ICD-10 Condition: Z006||Encounter for examination for normal comparison and control in clinical research program, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Activa Bioactive Restorative Resin |
Restoration was done on non carious cervical lesion of a premolar tooth and follow up of restoration was done for a period of 12 months. |
| Comparator Agent |
Spectrum Universal Microhybrid Composite Resin |
Restoration was done on non carious cervical lesion of a premolar tooth and follow up of restoration was done for a period of 12 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Vital teeth
2. Presence of occlusion and proximal contact with adjacent teeth
3. Presence of at least two NCCL’s with equal depth (1-2 mm)
|
|
| ExclusionCriteria |
| Details |
1. Class V lesion extending below the CEJ
2. Patients teeth having lesions more than 2 mm in depth
3. Teeth with cervical caries and gingival recession
4. Abnormal occlusion
5. Patients with poor oral hygiene
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Activa Bioactive resin as a restorative material for Non Carious Cervical Lesions may prove to be an excellent choice of material. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Activa Bioactive resin in comparison to Spectrum Universal Microhybrid Composite resin exhibited better adaptation, color match, retention surface texture and anatomic contour. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
02/06/2017 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Will be sent for publication after completion of trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims: Comparative clinical evaluation of Activa Bioactive resin with Spectrum Universal Microhybrid Composite resin in Non Carious Cervical Lesions (NCCLs). Background: To establish the most
suitable material for the restoration of NCCLs. Settings and Design: In vivo study.
Materials and Methods: A total of 150 NCCLs were restored, 75 restorations with Activa Bioactive resin ( group 1) and 75 restorations with Spectrum Universal Microhybrid Composite resin (group 2). Clinical
evaluation of the restorations was done following the modified Unites States Public
Health criteria by a single investigator. Data were formulated, and
statistical analysis was done.
Statistical Analysis Used: Mann Whitney U Test for intergroup comparison and Wicoxon matched pair test between time points.
Results: Both,
Activa Bioactive and Spectrum Universal showed clinically acceptable results
over a period of one year, with retention rates being 100% and 96.9%. Significant
difference was found between Activa Bioactive resin and Spectrum Universal Microhybrid Composite resin in relation to surface texture at 1-year (P < 0.05).
Conclusions: Activa Bioactive can be considered as an alternative choice for restoring NCCLs:
·
As it has excellent physical properties
·
Exhibits the property of release and recharge
of calcium, phosphate and fluoride which helps in forming a strong chemical bond
with the tooth surface, preventing microleakage. |