| CTRI Number |
CTRI/2015/02/005539 [Registered on: 12/02/2015] Trial Registered Retrospectively |
| Last Modified On: |
28/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of clinical performance of two different types of fillings as a treatment for caries lesions a Randomized Clinical trial |
|
Scientific Title of Study
|
Clinical performance of a class I nanohybrid composite restorations with light cure glassionomer liner and flowable composite liner a Randomized Clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSuhasiniK |
| Designation |
post graduate student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Narayana Dental college and Hospital
post graduate student,
Dept of conservative dentistry and endodontics
Chintareddy palem,
Nellore
Narayana Dental college and Hospital
post graduate student,
Dept of conservative dentistry and endodontics
Chintareddy palem,
Nellore
Nellore ANDHRA PRADESH 524002 India |
| Phone |
8121083483 |
| Fax |
|
| Email |
suhasinikrishtipati@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrKMadhusudhana |
| Designation |
Professor and HOD |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Narayana Dental college and Hospital
Professor and HOD
Dept of conservative dentistry and endodontics
Chintareddy palem,
Nellore Narayana Dental college and Hospital
Professor and HOD
Dept of conservative dentistry and endodontics
Chintareddy palem,
Nellore Nellore ANDHRA PRADESH 524002 India |
| Phone |
9391046354 |
| Fax |
|
| Email |
drmadhuk15@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrSuneel Kumar Chinni |
| Designation |
Reader |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Narayana Dental college and Hospital
Reader
Dept of conservative dentistry and endodontics
Chintareddy palem,
Nellore Narayana Dental college and Hospital
Reader
Dept of conservative dentistry and endodontics
Chintareddy palem,
Nellore Nellore ANDHRA PRADESH 524002 India |
| Phone |
9966313666 |
| Fax |
|
| Email |
chinnisk@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Narayana Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Narayana Dental college and Hospital |
| Address |
Narayana Dental college and Hospital
post graduate student
Dept of conservative dentistry and endodontics
Chintareddy palem
Nellore |
| Type of Sponsor |
Other [Private Dental college and Hospital] |
|
|
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 suhasini K |
Narayana Dental College and Hospital |
Narayana Dental College and Hospital,
First floor Room no 6
Dept of conservative dentistry and endodontics
chintareddypalem
Nellore-524003 Nellore ANDHRA PRADESH |
8121083483
suhasinikrishtipati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Narayana Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dental caries involving enamel and dentin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LC GIC |
Class I composite restoration with LC GIC liner
Duration : 30 minutes |
| Comparator Agent |
Smart Dentin Replacement Posterior light cure flowable liner |
Class I composite restoration with SDR liner
Duration : 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients age group between 18 to 40 years who
require at least 2 class I restorations
2 Patients with good oral hygiene
3 Patients with Normal occlusion
4 Occlusal caries with ICDAS code (4)
|
|
| ExclusionCriteria |
| Details |
1 Patients with fewer than 20 teeth
2 History of existing tooth sensitivity
3 Extremely poor oral hygiene with evident of
accumulation of plaque or calculus within
gingival pocket.
4 Bruxism
5 Pregnancy or Breast feeding
6 Chronic use of anti inflammatory, analgesic or
psychotrophic drugs
7 Non – Vital teeth
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical performance of Class I restorations with USPHS criteria |
Clinical performance of Class I restorations with USPHS criteria at 3,6,12 months time |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
— Composite restorations have become a routine procedure for class I and class II lesions. However, polymerization shrinkage and associated stresses remain a genuine problem. The physical mismatch between shrinkage prone restorative material and stiffer tooth structure may result in undesirable clinical situations such as microleakage, marginal staining, gap formation, postoperative sensitivity and enamel microcracks. Several strategies aimed at reducing polymerization shrinkage have been proposed. — Tetric N-Ceram is a light-curing, radiopaque nano-hybrid composite for restorative treatment. Resin composites based on nano technology have certain advantages such as reduced polymerization shrinkage, increased mechanical properties, better glossy retention and diminished wear. — SDR™ Smart Dentin Replacement is a one-component, fluoride-containing, visible light cured, radiopaque flowable resin composite restorative material.It is designed to be used as a base in class I and II restorations. SDR™ material has handling characteristics typical of a ―flowable composite, but can be placed in 4mm increments with minimal polymerization stress. SDR™ material has a self-leveling feature that allows intimate adaptation to the prepared cavity walls. It is designed to be overlayed with a universal/posterior composite.— The aim of this clinical study is to determine the clinical performance of the nano hybrid dental composite (Tetric N Ceram) in stress-bearing posterior cavities over a time period of 1 year with the use of SDR smart dentine replacement liner in one group and LC GIC liner in one group. |