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

Sponsor

Alshimaa Nasser Mahmoud (Other)

Overall Status

Completed

CT.gov ID

NCT05140447

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Preheating of Resin Composite	Other: preheating of resin composite	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Forty posterior teeth were randomly divided into two groups of 20 teeth. According to types of restorative materials used (A), the first group was restored by Bis-GMA free resin composite (A1) and the second group was restored by Bis-GMA containing resin composite (A2). Each group was subdivided into 2 subgroups of 10 teeth each according to preheating temperatures used (T), the first subgroup (T1) was preheated at 50◦ C and the second subgroup (T2) was preheated at 70◦ C.Forty posterior teeth were randomly divided into two groups of 20 teeth. According to types of restorative materials used (A), the first group was restored by Bis-GMA free resin composite (A1) and the second group was restored by Bis-GMA containing resin composite (A2). Each group was subdivided into 2 subgroups of 10 teeth each according to preheating temperatures used (T), the first subgroup (T1) was preheated at 50◦ C and the second subgroup (T2) was preheated at 70◦ C.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

Jun 15, 2021

Actual Study Completion Date :

Sep 28, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

pulpal floor temperature and restoration temperature [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

Secondary Outcome Measures

The effect of different preheating temperatures on restoration temperature and pulpal floor temperature [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

Other Outcome Measures

The difference in restoration and pulpal floor temperatures before and after curing of preheated resin composite [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry - Minia University	Minya		Egypt	61519

Sponsors and Collaborators

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