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Comparing The Clinical Performance Of Activaâ„¢ Bioactive Composite With Microhybrid Composite In Non Carious Cervical Lesions

Phase 2/3
Not yet recruiting
Conditions
Other specified diseases of hard tissues of teeth,
Registration Number
CTRI/2020/05/025235
Lead Sponsor
DR PRATHIMA B J
Brief Summary

The study is a randomized controlled clinical trial. Verbal and written consent will be obtained from the patients fulfilling the inclusion and exclusion criteria after briefing them about the procedure. Randomization will be done using computer generated tabulation method into

Group1 control  n 17 Filtek Z250 microhybrid composite restoration

Group2 experimental n 17 Activa**â„¢**bioactive composite restoration  based on the inclusion and exclusion criteria

**Clinical procedure**

Patients who will be selected for this study will be first evaluated for occlusal contacts.The patients who require occlusal corrections will undergo complete occlusal adjustments via selective grinding prior to restoration. After occlusal adjustments are done the same researcher will perform all restorative procedures. For standardization purposes all restorations will be carried out with rubber dam isolation and cleaning of the walls of the tooth to be restored with pumice paste and water. Cavities will be prepared by rounding the internal angles in order to reduce internal stress and all sharp line angles will be smoothened and beveled with a fine bur.

**Restorative procedure**

The composite placement will be done according to the manufacturers recommendations .The restorations will be finished and polished using supersnap kit

**Clinical evaluation**

Two blinded examiners  will evaluate the restorations with a mouth mirror and probe at baseline, 1 month, 6 months, and 1 year by modified USPHS criteria  which involves  retention, color match, marginal discoloration, marginal adaptation, secondary caries, surface texture, anatomic Form,  postoperative sensitivity and  also  occlusal interferences will be evaluated  using shim stock films

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
34
Inclusion Criteria

Patients having isolated abfraction lesions with more than 1 mm depth on the vestibular sides, associated with premolars and molars caused due to abnormal biomechanical loading forces will be selected for the study.

Exclusion Criteria

Poor oral hygiene Severe or chronic periodontitis Patients with severe occlusal problems and parafunctional habits Patients with temporo mandibular joint disorders Patients who give signs and symptoms of irreversible pulpitis A known allergic reaction to any of the components of the materials used, Non-vital, fractured or visibly cracked tooth Cervical caries.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Two blinded examiners will evaluate the restorations with a mouth mirror and probe at baseline, 1 month, 6 months, and 1 year by modified USPHS criteria which involves Retention, Color Match, Marginal Discoloration, Marginal Adaptation, Secondary Caries, Surface Texture, Anatomic Form, Postoperative Sensitivity and also occlusal interferences will be evaluated using Shim Stock films.Two blinded examiners will evaluate the restorations at baseline, 1 month, 6 months, and 1 year by modified USPHS criteria
Comparative evaluation of clinical performance of both the composites using modified USPHS criteriaTwo blinded examiners will evaluate the restorations at baseline, 1 month, 6 months, and 1 year by modified USPHS criteria
Secondary Outcome Measures
NameTimeMethod
Patients satisfaction andsatisfactory clinical performance of restorative material in abfraction lesions

Trial Locations

Locations (1)

K L E Societys Institute Of Dental Sciences

🇮🇳

Bangalore, KARNATAKA, India

K L E Societys Institute Of Dental Sciences
🇮🇳Bangalore, KARNATAKA, India
DR PRATHIMA B J
Principal investigator
8951201943
prathimabj2013@gmail.com

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