A One Year study to check the Clinical Performance and ColorMatching Potential of Newly Introduced Single Shade tooth colored filling material Vs Multiple Shade tooth colored filling material in Simple dental cavities

Phase 1/2

Completed

Conditions: CLASS 1 CARIOUS LESION IN TOOTH
Dental caries on pit and fissure surface,

Registration Number: CTRI/2021/04/032635

Lead Sponsor: DR PRIYA PORWAL

Brief Summary: 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 â€“ 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 70

Inclusion Criteria

Patients between 18 â€“ 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 will be included.
Patients with atleast two class I carious lesion in opposite side will be included in the study.
Teeth with secondary decay or fracture of old amalgam and composite fillings will be included.
Teeth with opposite and adjacent tooth in contact will be included.
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.

Exclusion Criteria

Patients with poor oral hygiene will be excluded from the study.
Patients with severe or chronic periodontitis and heavy bruxism will be excluded.
Patients with malocclusion, rotated teeth or with attrition will be excluded.
Teeth with pulpal and/ or periapical pathology will be excluded.
Teeth with developmental anomaly or pathology or congenital defects will be excluded.
Teeth which have to be used as an abutment will be excluded.
Pregnant and lactating women will be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The results of the study will help us know which composite material is better clinically	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
and aesthetically among single shade composites and multi shade composites when	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
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 Measures

Name	Time	Method
it will help the practitioners to resolve the	shade match dilemma reducing the chair side time for shade selection and cutting the

Trial Locations

Locations (1): Room no 8 department of conservative dentistry and endodontics, k m shah dental college and hospital
🇮🇳
Vadodara, GUJARAT, India
Room no 8 department of conservative dentistry and endodontics, k m shah dental college and hospital
🇮🇳Vadodara, GUJARAT, India
DR PRIYA PORWAL
Principal investigator
7899744426
piyajain4695@gmail.com