Performance of Curing Times and Intensitis

NCT05334901 | Completed DMC

• 1 other identifier: OPR 22/3/2022
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Clinical Performance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

High intensity light cure

EXPERIMENTAL

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

Low intensity light cure

ACTIVE COMPARATOR

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

Interventions

High intensity light cure DEVICE

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

High intensity light cure; Low intensity light cure

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
• Non-vital teeth.
• Secondary carious lesions.
• Advanced periodontal disease

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of Dentistry

Giza, Cairo Governorate, 002, Egypt

Location

Faculty of Dentistry

Cairo, 002, Egypt

Location

Study Officials

• Roaa Azazy, Master

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: roaa.sabry@dentistry.cu.edu.eg

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 19, 2022
• Study Start: April 22, 2022
• Primary Completion: April 22, 2022
• Study Completion: October 22, 2022
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: T0: baseline (after one week) T1: after 6 months T2: after 12 months
• Access Criteria: 1. Permanent premolars or molars. 2. Moderate to deep compound class II cavities.

Locations

EG (2)