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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2018/10/015880
Date of registration: 03-10-2018
Prospective Registration: Yes
Primary sponsor: Dr Riddhi Hirani
Public title: Comparison to check the long term use of three different filling material in cavities.
Scientific title: Comparative Evaluation Of Cention â??N, Equia Forte And Activa Bulk Fill Material In Class I Posterior Restortions- A Randomized Controlled Trial
Date of first enrolment: 21-10-2018
Target sample size: 144
Recruitment status: Not Yet Recruiting
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19382
Study type:  Interventional
Study design:  Randomized, Parallel Group Trial
Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Participant and Outcome Assessor Blinded
 
Phase:  N/A
Countries of recruitment
India
Contacts
Name: Renu Batra   
Address:  Manubhai Patel Dental college, Department of conservative and Endodontic,near Vishwjyoti Asharm, Munjmahuda,Vadodara 390011 Vadodara, GUJARAT India
Telephone: 9537528008
Email: renubatra@gmail.com
Affiliation:  Manubhai Patel Dental College
Name: DRRIDDHI HIRANI   
Address:  manubhai patel dental college, department of conservative and endodontic,near vishwjyoti asharm, munjmahuda,vadodara 16,A Durganagar Society, besides tube company ,O.P Road 390011 Vadodara, GUJARAT India
Telephone: 9537528008
Email: renubatra@gmail.com
Affiliation:  Manubhai Patel Dental College
Key inclusion & exclusion criteria
Inclusion criteria: Age 16-50.

Class I Cavities.

Willing to Participate in the Study.

Exclusion criteria: Pathologic pulpal diagnosis with pain(non-vital).

Defective restoration adjacent to or opposing the tooth.

Rampant caries.

Poor oral hygiene.

Severe or chronic periodontitis.

Heavy bruxism.

Allergy to materials used in this trial

With previous restorations, tooth surface loss (attrition, erosion, abrasion or abfraction).



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: 4- Measurement and Monitoring Health Condition 2: null- suffering from dental caries and seaking treatment
Intervention(s)
Intervention1: Cention-N
GC Equia forte
Activa bioactive restorative: Isolation will be done with help of rubber dam (HU- FRIEDY ) followed by Preparation of Class I cavities.
The overall dimensions and depth of cavities were standardized follows.1.5 mm from central groove ,4 mm in length mesio â?? distally, 2 mm bucco- palatally.
class I cavity will be prepared by removing caries using a round and NO.245 straight fissure diamond bur (Mani Inc. Japan) in a high-speed air- turbine hand piece (NSK INC.Japan) with copious water irrigation. Burs will replaced after every eight preparation and cavity will be restored with cention n, equia forte, activa bioactive restorative according to manufactures instructions.

Control Intervention1: Cention n
: Cention n is an â??alkasiteâ?? restorative. alkasite refers to a new category of filling material, which like compomer or ormocer materials is essentially a subgroup of the composite material class. this new category utilizes an alkaline filler, capable of releasing acid-neutralizing ions.
cention n is a tooth-coloured, basic filling material for direct restorations. it is self-curing with optional additional light-curing. cention n is available in the tooth shade A2.
Equia (Gc, America) Is A New Glass Ionomer Restorative System. It Is A Combination Of A Self-Adhesive, Chemically Cured, Highly Filled Gic (Fuji Ix Gp Extra, Gc) And A Selfadhesive, Light Cured, Filled Resin Surface Sealant (G-Coat Plus, Gc). This Material has property of Increased Fracture Toughness, Flexural Strength, And Flexural Fatigue Resistance Which Are Required In Class I Restorations .
ACTIVA BioACTIVE-RESTORATIVE is a highly esthetic, bioactive composite that delivers all the advantages of glass ionomers in a strong, resilient, resin matrix that w
Primary Outcome(s)
USPHS - United states public health servicesTimepoint: 1 month

3 month

6 month
Secondary Outcome(s)
VAS -visual analogue ScaleTimepoint: 24 hrs,1 week ,1 months
Secondary ID(s)
NIL
Source(s) of Monetary Support
Dr. Riddhi Hirani Manubhai Patel Dental college, Department of conservative and Endodontic,near Vishwjyoti Asharm, Munjmahuda,Vadodara
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 20/03/2017
Contact:
Dr. Riddhi Hirani
Results
Results available:
Date Posted:
Date Completed:
URL:
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