CClinicalTrials.gg
Sign In
CompletedNCT05140447Updated Dec 1, 2021

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

An interventional study of preheating of resin composite in Preheating of Resin Composite, sponsored by Alshimaa Nasser Mahmoud. Completed at 1 site in Egypt. Open to participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-01.

Sponsored by Alshimaa Nasser Mahmoud · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Apr 2021, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study 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

02

Conditions studied

  • 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
03

In context

Lead sponsor

This is the only study on the registry with Alshimaa Nasser Mahmoud as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • Otherpreheating 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.

    Also known as: warming of resin composite

06

What researchers measure

Primary outcomes

  1. pulpal floor temperature and restoration temperature

    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

    Time frame: one year

Secondary outcomes

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

    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

    Time frame: one year

Other outcomes

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

    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

    Time frame: one year

07

Study locations

1 site
  • Faculty of Dentistry - Minia University
    Minya, 61519, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05140447
Lead sponsor
Alshimaa Nasser Mahmoud
Responsible party
Alshimaa Nasser Mahmoud (post grade student, Minia University) — Sponsor-investigator
First posted
Dec 1, 2021
Start date
Apr 1, 2021
Primary completion
Jun 15, 2021
Completion
Sep 28, 2021
Last update
Dec 1, 2021

Study contacts

Mona I Riad, Professor
study director · Professor at Faculty of Dentistry Cairo University
Nermin A Mahmoud, Lecturer
study director · Lecturer at Faculty of Dentistry Minia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion