Performance of Curing Times and Intensitis

Effect of Different Curing Times and Intensities on The Performance of Compound Class II Bulk-Fill Resin Composite Restorations: (An In-Vivo and In-Vitro Study)

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

Study Overview

• Status: Completed
• Conditions: Clinical Performance
• Intervention / Treatment: Device: High intensity light cure

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 002
    • Faculty of Dentistry
  • Cairo
    • Giza, Cairo, Egypt, 002
      • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High intensity light cure; 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	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
Active Comparator: Low intensity light cure; Conventional light curing (1200 mw/cm2) for long exposure time (20 seconds) to achieve the slower rate of conversion allowing for a better flow of the material, which decreases contraction stress in the filling material	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Roaa Azazy, Master, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Actual): April 22, 2022
• Study Completion (Actual): October 22, 2022

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: OPR 22/3/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 incompound Class II cavities of posterior teeth
• IPD Sharing Time Frame: T0: baseline (after one week) T1: after 6 months T2: after 12 months
• IPD Sharing Access Criteria: Permanent premolars or molars.; Moderate to deep compound class II cavities.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No