Clinical trial NCT05140447: Temperature Change of the Pulpal Floor and Restoration With Preheated Resin Composite (A Randomized Clinical Trial)
Official title: Temperature Change of the Pulpal Floor and Restoration With Preheated Resin Composite (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preheating of Resin Composite
Keywords: preheating of resin composite
pulpal floor temperature
resin composite
BIS-GMA free resin composite
BIS-GMA containing resin composite
restoration temperature
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: pulpal floor temperature and restoration temperature
timeFrame: one year
Secondary outcomes:
measure: The effect of different preheating temperatures on restoration temperature and pulpal floor temperature
timeFrame: one year
Other outcomes:
measure: The difference in restoration and pulpal floor temperatures before and after curing of preheated resin composite
timeFrame: one year
Locations:
city: Minya
country: Egypt
facility: Faculty of Dentistry - Minia University
Study officials:
affiliation: Professor at Faculty of Dentistry Cairo University
name: Mona I Riad, Professor
role: STUDY_DIRECTOR
affiliation: Lecturer at Faculty of Dentistry Minia University
name: Nermin A Mahmoud, Lecturer
role: STUDY_DIRECTOR
References: