Completed

NCT Number: NCT05140447

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

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

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Key information

Conditions

Preheating of Resin Composite

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry - Minia University

Minya, 61519, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

preheating of resin composite

Other

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

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and collaborators

Lead sponsor

Alshimaa Nasser Mahmoud