Preheating of Resin CompositeNCT05140447
Temperature Change of the Pulpal Floor and Restoration With Preheated Resin Composite (A Randomized Clinical Trial)
A study testing preheating of resin composite in people with Preheating of Resin Composite, run by Alshimaa Nasser Mahmoud at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Preheating of Resin Composite
- What is being tested?
- preheating of resin composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 28 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Preheating of Resin Composite
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preheating of resin compositeOther
Also called warming 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.
| Study group | Role | What they receive |
|---|---|---|
| Admira 50º C | Active comparator | in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 50º C Receives: Other: preheating of resin composite |
| Admira 70º C | Active comparator | in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 70º C Receives: Other: preheating of resin composite |
| Viscalor 50º C | Active comparator | in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 50º C Receives: Other: preheating of resin composite |
| Viscalor 70º C | Active comparator | in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 70º C Receives: Other: preheating of resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Apr 2021
- Primary completion15 Jun 2021
- Study completion28 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preheating of Resin CompositeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alshimaa Nasser Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alshimaa Nasser Mahmoud, Minia University
- Investigators
- Mona I Riad, Professor, Study director, Professor at Faculty of Dentistry Cairo UniversityNermin A Mahmoud, Lecturer, Study director, Lecturer at Faculty of Dentistry Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140447
- Sponsor's protocol ID
- 490
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Change of the Pulpal Floor and Restoration With Preheated Resin Composite (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05140447
- Acronym / sponsor ID
- 490
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alshimaa Nasser MahmoudUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Admira 50º C | Active comparator | Other: preheating of resin compositein this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 50º C |
| Admira 70º C | Active comparator | Other: preheating of resin compositein this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 70º C |
| Viscalor 50º C | Active comparator | Other: preheating of resin compositein this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 50º C |
| Viscalor 70º C | Active comparator | Other: preheating of resin compositein this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 70º C |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preheating of resin compositeAlso: warming of resin compositeevaluate 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 | Admira 50º C, Admira 70º C, Viscalor 50º C, Viscalor 70º C |
Primary outcome
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
1 secondary outcome
The effect of different preheating temperatures on restoration temperature and pulpal floor temperature
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preheating of resin composite in people with Preheating of Resin Composite, run by Alshimaa Nasser Mahmoud at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulpal floor temperature and restoration temperature (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.