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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05334901
Other study ID # OPR 22/3/2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 22, 2022
Est. completion date October 22, 2022

Study information

Verified date November 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to compare the effect of high intensity light cure (2200 mw/cm2) for 1 second with low intensity light cure (1200 mw/cm2) for 20 seconds on the clinical performance of bulk fill resin composite restorations in compound Class II cavities of posterior teeth


Description:

The prepared cavities will be conditioned with 35% phosphoric acid gel for15 seconds, then will be rinsed and dried with compressed air. Then application of universal adhesive system to all cavity with bond brush then light cured for 10 seconds using LED light curing unit (1200 mw/cm2). Extra-Fill bulk fill resin composite will be applied in onebulk increment and will be light polymerized for 1 second using (LED) light curing unit (2200 mw/cm2).for intervention group Extra-Fill bulk fill resin composite will be applied in one bulk increment and will be light polymerized for 20 seconds using (LED) light curing unit (1200 mw/cm2) fot control group


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date October 22, 2022
Est. primary completion date April 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Permanent premolars or molars. - Moderate to deep compound class II cavities. - Vital with the positive reaction to a cold thermal stimulus. - Absence of parafunctional habits Exclusion Criteria: - Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure. - Non-vital teeth. - Secondary carious lesions. - Advanced periodontal disease

Study Design


Related Conditions & MeSH terms


Intervention

Device:
High intensity light cure
Bulk fill resin composite restoration cured with high intensity light curing (2200 mw/cm2)To achieve increased power and a wider spectrum for short exposure time (1 second) to overcome resin composite restoration techniques sensitivity and shorten the clinical procedure

Locations

Country Name City State
Egypt Faculty of Dentistry Cairo
Egypt Faculty of Dentistry Giza Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical performance Clinical performance of bulk fill resin composite restorations will be evaluated by modified USPHS Criteria includes:
Marginal Discoloration
Marginal adaptation
Secondary caries
Postoperative sensitivity
For each criteria one score will be chosen from 3 scores (Alpha,Bravo&Charlie).
Change from the baseline at 6 months and12 months
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