Temperature Change of the Pulpal Floor and Restoration With Preheated Resin Composite (A Randomized Clinical Trial)

November 19, 2021 updated by: Alshimaa Nasser Mahmoud

clinical evaluation of the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.

Hypothesis: Could the preheated composite affect the temperature of the pulpal floor

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61519
        • Faculty of Dentistry - Minia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy men and women patients of 25-45 years.
  • They should have a good oral hygiene level.
  • Presence of at least two posterior class I or II carious lesions to be restored with two different composite resin restorations.
  • All carious lesions in selected patients didn't close to the pulp in the preoperative radiograph.
  • No preoperative pain.
  • Normal occlusal contact with opposing teeth.
  • No history of periodontal treatment, including periodontal surgery, in the past year.
  • All patients had to sign a written consent before being included.
  • A good likelihood of recall availability.

Exclusion Criteria:

  • patient with severe periodontitis or severe erosion damage.
  • patients with a compromised medical history or had received therapeutic irradiation to the head and neck region.
  • If analgesics or antibiotics had administered by the patient during the past 12 hours preoperatively as it might alter their pain perception.
  • patients reported bruxism or clenching.
  • Greater than grade I mobility or pocket depth greater than 5mm.
  • Non-restorable teeth or hopeless teeth.
  • Immature teeth.
  • Radiographic evidence of external or internal root resorption.
  • Alcoholic and smoker patients.
  • Pregnant or breastfeeding ladies.
  • Patients who had physical disabilities, or who are unable to brush their teeth.
  • Individuals who had sensitive teeth but with one of the following conditions was excluded from the study, teeth with large restoration, abutment of teeth of removable partial dentures, dental restorations, abutment of teeth of removable partial dentures, enamel cracks, leakage of fillings or other restorations teeth, dental pulp lesions, dental abscesses, pulpitis, and atypical facial pain.
  • Patients who had non-carious lesions like attrition, erosion, abrasion or abfraction.
  • Patients had participated in a clinical trial within 6 months before commencement of this trial.
  • Patients unable to return for a recall appointment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Admira 50º C
in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 50º C
Other: preheating of resin composite
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Other Names:
  • warming of resin composite
Active Comparator: Admira 70º C
in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 70º C
Other: preheating of resin composite
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Other Names:
  • warming of resin composite
Active Comparator: Viscalor 50º C
in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 50º C
Other: preheating of resin composite
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Other Names:
  • warming of resin composite
Active Comparator: Viscalor 70º C
in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 70º C
Other: preheating of resin composite
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Other Names:
  • warming of resin composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulpal floor temperature and restoration temperature
Time Frame: one year

evaluation the effect of preheating BIS GMA free resin composite at different temperature on temperature change of pulpal floor and restoration and compare it with BIS GMA containing resin composite

All readings were taken with the presence of a rubber dam and recorded in Celsius (°C).

Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure. (C1): pulpal floor temperature during placement of preheated composite. (C2): top composite surface after packing and before curing. (C3): pulpal floor temperature after curing of the preheated composite. (C4): top composite surface after curing. The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of different preheating temperatures on restoration temperature and pulpal floor temperature
Time Frame: one year
Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure. (C1): pulpal floor temperature during placement of preheated composite. (C2): top composite surface after packing and before curing. (C3): pulpal floor temperature after curing of the preheated composite. (C4): top composite surface after curing. The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in restoration and pulpal floor temperatures before and after curing of preheated resin composite
Time Frame: one year
Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure. (C1): pulpal floor temperature during placement of preheated composite. (C2): top composite surface after packing and before curing. (C3): pulpal floor temperature after curing of the preheated composite. (C4): top composite surface after curing. The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alshimaa Nasser Mahmoud

Investigators

  • Study Director: Mona I Riad, Professor, Professor at Faculty of Dentistry Cairo University
  • Study Director: Nermin A Mahmoud, Lecturer, Lecturer at Faculty of Dentistry Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

September 28, 2021

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 490

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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