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CTRI Number  CTRI/2021/04/032635 [Registered on: 07/04/2021] Trial Registered Prospectively
Last Modified On: 22/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A One Year study to check the Clinical Performance and Color Matching Potential of Newly Introduced Single Shade tooth colored filling material Vs Multiple Shade tooth colored filling material in Simple dental cavities 
Scientific Title of Study   “A One Year Comparative Evaluation Of Clinical Performance And Color Matching Potential Of Newly Introduced Single Shade Composites Vs Multiple Shade Composites In simple Class I Carious Lesions - A Randomized Clinical 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 PRIYA PORWAL 
Designation  POST GRADUATE STUDENT 
Affiliation  K.M.SHAH DENTAL COLLEGE AND HOSPITAL 
Address  ROOM NO 8 Department of conservative dentistry and endodontics, K.M.Shah dental college and hospital, sumandeep vidyapeeth campus, piparia, vadodara, gujarat

Vadodara
GUJARAT
391760
India 
Phone  7899744426  
Fax    
Email  piyajain4695@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NIMISHA SHAH 
Designation  PROF. AND HEAD OF THE DEPARTMENT AND PG GUIDE 
Affiliation  K.M.SHAH DENTAL COLLEGE AND HOSPITAL 
Address  ROOM NO 8 Department of conservative dentistry and endodontics, K.M.Shah dental college and hospital, sumandeep vidyapeeth campus, piparia, vadodara, gujarat

Vadodara
GUJARAT
391760
India 
Phone  9998994299  
Fax    
Email  nshah7873@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR NIMISHA SHAH 
Designation  PROF. AND HEAD OF THE DEPARTMENT AND PG GUIDE 
Affiliation  K.M.SHAH DENTAL COLLEGE AND HOSPITAL 
Address  ROOM NO 8 Department of conservative dentistry and endodontics, K.M.Shah dental college and hospital, sumandeep vidyapeeth campus, piparia, vadodara, gujarat

Vadodara
GUJARAT
391760
India 
Phone  9998994299  
Fax    
Email  nshah7873@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, K M SHAH DENTAL COLLEGE 
 
Primary Sponsor  
Name  DR PRIYA PORWAL 
Address  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS ROOM NO. 8, K.M.SHAH DENTAL COLLEGE AND HOSPITAL, SUMANDEEP VIDYAPEETH CAMPUS, PIPARIA, VADODARA 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR PRIYA PORWAL  Room no 8 department of conservative dentistry and endodontics, k m shah dental college and hospital  k m shah dental college and hospital, sumandeep vidyapeeth, piparia, vadodara
Vadodara
GUJARAT 
7899744426

piyajain4695@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  CLASS 1 CARIOUS LESION IN TOOTH 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  3M FILTEK ESPE COMPOSITE   PATIENTS HAVING CLASS 1 CARIOUS LESIONS IN MOLARS OR PREMOLARS WILL BE TAKEN UP FOR THE STUDY. AFTER RADIOGRAPHIC EXAMINATION AND CARIES REMOVAL, SHADE SELECTION WILL BE DONE. THIS IS FOLLOWED BY LAYER BY LAYER ADDITION OF DENTIN AND ENAMEL SHADES AND FINISHING AND POLISHING IN THE END. 
Intervention  OMNICHROMA SINGLE SHADE COMPOSITE  PATIENTS HAVING CLASS 1 CARIOUS LESIONS IN MOLARS OR PREMOLARS WILL BE TAKEN UP FOR THE STUDY. AFTER CARRYING OUT RADIOGRAPHIC EXAMINATION AND STANDARD CARIES REMOVAL PROTOCOL, OMNICHROMA COMPOSITE WILL BE USED TO RESTORE THE TOOTH FOLLOWED BY FINISHING AND POLISHING. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients between 18 – 60 years of age with simple Class I lesions of molars and
premolars except those requiring pulp capping will be included in the study.
2. Teeth with radiographic findings revealing radiolucency in coronal dentin will be
included.
3. Patients with atleast two class I carious lesion in opposite side will be included in
the study.
4. Teeth with secondary decay or fracture of old amalgam and composite fillings
will be included.
5. Teeth with opposite and adjacent tooth in contact will be included.
6. A written informed consent will be taken from all the patients and only those
patients ready to sign the consent form will be included in the study.
 
 
ExclusionCriteria 
Details  1. Patients with poor oral hygiene will be excluded from the study.
2. Patients with severe or chronic periodontitis and heavy bruxism will be excluded.
3. Patients with malocclusion, rotated teeth or with attrition will be excluded.
4. Teeth with pulpal and/ or periapical pathology will be excluded.
5. Teeth with developmental anomaly or pathology or congenital defects will be
excluded.
6. Teeth which have to be used as an abutment will be excluded.
7. Pregnant and lactating women will be excluded.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The results of the study will help us know which composite material is better clinically
and aesthetically among single shade composites and multi shade composites when
used in class I carious lesions. 
The results of the study will help us know which composite material is better clinically
and aesthetically among single shade composites and multi shade composites when
used in class I carious lesions after baseline, 6 months and one year 
 
Secondary Outcome  
Outcome  TimePoints 
it will help the practitioners to resolve the
shade match dilemma reducing the chair side time for shade selection and cutting the
cost of keeping a large inventory.
 
baseline six months one year 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   15/04/2021 
Date of Study Completion (India) 11/01/2022 
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   NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Resin composite restorative materials are widely used because of their excellent esthetics, acceptable longevity, and relatively low costs compared with ceramic restorations. Most composites today depend on the color of red and yellow dyes added to the resin material to emulate tooth shades. This means that dentists must keep a large inventory of different composites to accommodate a variety of patients. Composite materials and restorative techniques that allow the use of simplified clinical protocols are highly desirable among clinicians in order to reduce chairside time. Since color selection might be challenging and subjected to environmental and operator-dependent variables, a tendency to simplify shade selection has led to the development of the OMNICHROMA, a single shade universal composite. OMNICHROMA is the first universal composite that offers one shade to match all patients. To ensure an esthetic outcome and an imperceptible match of the color of the restorative material to that of the tooth. the color matching potential of the composites will be checked by visual evaluation and instrumental evaluation using digital cameras and adobe software. clinical performance of the composites will be checked with modifies USPHS criteria. Considering 0.57 mean the difference in delta E between two groups with SD 0.85, a minimum of 70 samples (35 in each group) will be taken with 95% confidence and 80% power. N = 2*(Z1+Z2) 2*SD2 /d2
Patients between 18 – 60 years of age with simple Class I lesions of molars and premolars except those requiring pulp capping will be included in the study. Teeth with radiographic findings revealing radiolucency in coronal dentin, Patients with at least two class I carious lesions on the opposite side will be included in the study. Written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study. Teeth with pulpal and/ or periapical pathology will be excluded. Teeth with developmental anomaly or pathology or congenital defects will be excluded. Teeth that have to be used as an abutment will be excluded.
in group A, 
patients having class 1 carious lesions in molars or premolars will be taken up for the study. after radiographic examination and caries removal, shade selection will be done. this is followed by layer by layer addition of dentin and enamel shades and finishing and polishing in the end. In group B, patients having class 1 carious lesions in molars or premolars will be taken up for the study. after carrying out the radiographic examination and standard caries removal protocol, omnichroma composite will be used to restore the tooth followed by finishing and polishing.  the photographic evaluation will be done of the pre and post-operative conditions with standardized protocols which include the usage of a Digital Photography Unit containing a DSLR Camera (Canon), 100 mm focal length macro lens with a ratio of 1.5, a close-up Speedlight flash, retractors (Lip and cheek), contractors, and mirrors. All photographs will be taken with standardized parameters. Images will be transferred to a digital adobe photoshop software for color matching analysis using CIELab coordinates. The visual analysis will be performed using 2 previously calibrated evaluators, demonstrating superior color discrimination competency according to ISO/TR 28642:2016.25 Under the illumination of a D65 light source and using a 0o /45o viewing geometry, the observers will perform blind visual evaluations of all specimens in random order. Interrater reliability will be analyzed using the kappa test with a value of 0.85. Along with this, the clinical evaluation will be done based on modified USPHS criteria

 
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