The Effect of Preheating Cycles of Resin Composite on Both Hypersensitivity and Clinical PerformanceNCT05289479

Pre-heated Resin Composite Restoration

A study testing Pre-heating of resin composite before application and no pre-heating of resin composite before application in people with The Effect of Preheating Cycles of Resin Composite on Both Hypersensitivity and Clinical Performance, run by Minia University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

this study is conducted to evaluate the post-operative hypersensitivity and clinical performance of preheated resin composite with different number of pre-heating cycles in class II carious lesions compared to resin composite restorations without preheating using Modified US Public Health Service Clinical Criteria… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: The Effect of Preheating Cycles of Resin Composite on Both Hypersensitivity and Clinical Performance
What is being tested?: Pre-heating of resin composite before application and no pre-heating of resin composite before application
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 1 siteEgypt
Study dates: 30 Jan 2021to 1 Mar 2022
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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1- Moderate to deep proximal primary carious lesions" Class II" where each patient will have 2 "Class II" cavities on different sides.
2- Overall good oral hygiene status 3- Patients showing no signs of spontaneous dental or orofacial pain. 4- Selected teeth should not have any signs or symptoms of pulpal and periapical disease.
5- The selected teeth should have an occlusal contact with natural or crowned antagonist teeth, so that it could be tested for post-operative pain during chewing of food.
6- The selected teeth should have healthy gingival tissues, without gingival recession or alveolar bone loss.

Who cannot join

1. Patients with a compromised medical history, or had received therapeutic irradiation to the head and neck region.
2. Acute and chronic systemic diseases, immune-compromised patients. 3. Medical problems preventing the participant from showing up to describe the presence of hypersensitivity 4. Alcoholic and smoker patients. 5. Pregnant or breastfeeding 6. Patients having physical disabilities, or who are unable to brush their teeth 7. Patients who have a history of allergies to any personal oral care product or ingredient, or who are taking anti-inflammatory drugs within the previous month.
8. Patients taking analgesics that could alter their normal pain perception level.
9. Medical, psychiatric, or pharmaco-therapeutic histories that might compromise the study protocol including chronic use of ant-inflammatory, analgesic, psychotropic drugs.
10. Individuals who had sensitive teeth but with one of the following conditions will be excluded from the study, teeth with large restorations, abutment of teeth of removable par¬tial dentures, dental caries, enamel cracks, leakage of fillings or other restorations, cracked teeth, dental pulp lesions, den¬tal abscesses, pulpitis, and atypical facial pain.
11. Defective restorations that needs replacement for esthetic reasons. 12. Patient with severe periodontitis or severe erosion damage. 13. Patients had participated in a clinical trial within 6 months before commencement of this trial.
14. Patients unable to return for recall appointment. 15. Previously restored teeth showing secondary caries. 16. Occlusal disturbances or temporo-mandibular joint problems involving gingival recession or alveolar bone loss.
17. Patients on orthodontic treatment.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry
Minya, Minia City, 61511

Other trials in Egypt

About this study

Official title: Effect Of Repeated Pre-Heating Of Resin Composite Restoration On Its Clinical Performance And Post-Operative Dentin Hypersensitivity "A Randomized Clinical Trial"

Read the detailed description

Scientific Background One of the main problems associated with composite resin restorations is poor adaptation and gap formation between the restorative material and the cavity walls, resulting in the micro-leakage of oral fluids and accumulation of fluids responsible for many problems such as postoperative hypersensitivity, marginal discoloration and recurrent caries. Despite of recent developments in dental restorative materials and techniques, postoperative sensitivity following the application of a posterior resin composite restoration is often reported by dentists, as a clinical problem. Pre-application warming of dental resin composite restorative materials, is considered one of the modern modifications for the application of resin composite, which reduces viscosity and increases flowability, that in turn secures superior adaptation to the prepared cavity walls. Resin composite warming appliances found in the market nowadays, offer multiple choices for preheating either in different temperatures or in the form of the cassettes which could be compatible with different supplied forms from different manufacturers "capsules or syringes". Multiple cycles of preheating for the used composite resin syringe can affect both marginal integrity and mechanical properties of the resin composite according to the number of cycles applied. Increasing the temperature of dental resin composite before application can aid in monomer mobility inside its matrix giving high quality of degree of conversion and more highly cross-linked polymeric network. This kind of change of the rheology of the resin composite can aid in decreasing the postoperative hyper-sensitivity. However, an intensive review of literature failed to disclose the effect of using resin composite preheated for multiple times with different temperatures on the post-operative hypersensitivity.
Statement of the problem Using the same resin composite syringe that previously preheated multiple times in different daily restorative cases, can adversely affect the properties and the performance of the applied resin composite.
Hypothesis The null hypothesis is that using resin composite previously preheated for different cycles will not be different in reducing postoperative hypersensitivity, marginal integrity and mechanical properties of the resin composite as without preheating.
The sample size calculation
primary outcome: This power analysis used marginal integrity after 12 months as the primary outcome. Based upon the results of Kurdi R and Abboud SA (2016); Bulk Fill composite showed 13 cases with (Alpha) score and 4 cases with (Beta) score, respectively. The effect size (w) was 0.53. Using alpha (α) level of (5%) and Beta (β) level of (20%) i.e. power = 80%; the minimum estimated sample size was 28 cases. Sample size was increased to 35 cases to compensate for a drop-out rate of 25% after 12 months. Sample size calculation was performed using G*Power Version 3.1.9.2.
secondary outcome: This power analysis used hypersensitivity grades after one day in patient with medium cavity depth as the primary outcome. The effect sizes w1 = (1.4) and w2 = (1.11) were calculated based upon the results of Ragab H (2018). Using alpha (α) level of (5%) and Beta (β) level of (20%) i.e. power = 80%; the minimum estimated sample size was a total of 11 subjects. Sample size was increased to a total of 14 subjects (7 subjects per group) to compensate for a dropout rate of 25%. Sample size calculation was performed using G*Power Version 3.1.9.2

Conditions: The Effect of Preheating Cycles of Resin Composite on Both Hypersensitivity and Clinical Performance
Being tested: Pre-heating of resin composite before application, no pre-heating of resin composite before application

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pre-heating of resin composite before applicationProcedure or surgery
the effect of preheating of resin composite before application in class II cavities
no pre-heating of resin composite before applicationProcedure or surgery
The control group

Study groups in NCT05289479
Study group	Role	What they receive
No pre-heating "control group"	Active comparator	resin composite is used at room temperature without preheating Receives: Procedure: no pre-heating of resin composite before application
0ne cycle pre-heating	Active comparator	one cycle preheating of resin composite at 68 degree Celsius before application Receives: Procedure: Pre-heating of resin composite before application
ten cycles pre-heating	Active comparator	ten cycles preheating of resin composite at 68 degree Celsius before application Receives: Procedure: Pre-heating of resin composite before application

What is being measured

The primary outcome is the main question the study is designed to answer.

United States Public Health Service (USPHS) criteria
Clinical performance of the restorations tested for 9 months
Measured: 9 months

Secondary outcomes (1)

Post-Operative Dentin Hypersensitivity
Intensity of postoperative pain measured using a Modified Visual Analogue scale before and after filling for 1 month postoperatively.
The score of scale from 0 to 10 where zero has no postoperative sensitivity at all and ten means the worst postoperative sensitivity is felt by the patient.
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 20211 Mar 2022

First posted21 Mar 2022
Study start30 Jan 2021
Primary completion30 Jan 2022
Study completion1 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for The Effect of Preheating Cycles of Resin Composite on Both Hypersensitivity and Clinical PerformanceStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05289479
Sponsor's protocol ID: 73-11\9\2022-440
Status last verified: Jul 2022
First submitted: 11 Mar 2022
Last updated: 28 Jul 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect Of Repeated Pre-Heating Of Resin Composite Restoration On Its Clinical Performance And Post-Operative Dentin Hypersensitivity "A Randomized Clinical Trial"
ClinicalTrials.gov ID: NCT05289479
Acronym / sponsor ID: 73-11\9\2022-440
Conditions: The Effect of Preheating Cycles of Resin Composite on Both Hypersensitivity and Clinical Performance
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Minia UniversityUniversity, hospital or other
Study start: 30 Jan 2021 (actual)
Primary completion: 30 Jan 2022 (actual)
Study completion: 1 Mar 2022 (actual)
First posted: 21 Mar 2022 (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.

Detailed description

Scientific Background One of the main problems associated with composite resin restorations is poor adaptation and gap formation between the restorative material and the cavity walls, resulting in the micro-leakage of oral fluids and accumulation of fluids responsible for many problems such as postoperative hypersensitivity, marginal discoloration and recurrent caries. Despite of recent developments in dental restorative materials and techniques, postoperative sensitivity following the application of a posterior resin composite restoration is often reported by dentists, as a clinical problem. Pre-application warming of dental resin composite restorative materials, is considered one of the modern modifications for the application of resin composite, which reduces viscosity and increases flowability, that in turn secures superior adaptation to the prepared cavity walls. Resin composite warming appliances found in the market nowadays, offer multiple choices for preheating either in different temperatures or in the form of the cassettes which could be compatible with different supplied forms from different manufacturers "capsules or syringes". Multiple cycles of preheating for the used composite resin syringe can affect both marginal integrity and mechanical properties of the resin composite according to the number of cycles applied. Increasing the temperature of dental resin composite before application can aid in monomer mobility inside its matrix giving high quality of degree of conversion and more highly cross-linked polymeric network. This kind of change of the rheology of the resin composite can aid in decreasing the postoperative hyper-sensitivity. However, an intensive review of literature failed to disclose the effect of using resin composite preheated for multiple times with different temperatures on the post-operative hypersensitivity.
Statement of the problem Using the same resin composite syringe that previously preheated multiple times in different daily restorative cases, can adversely affect the properties and the performance of the applied resin composite.
Hypothesis The null hypothesis is that using resin composite previously preheated for different cycles will not be different in reducing postoperative hypersensitivity, marginal integrity and mechanical properties of the resin composite as without preheating.
The sample size calculation
primary outcome: This power analysis used marginal integrity after 12 months as the primary outcome. Based upon the results of Kurdi R and Abboud SA (2016); Bulk Fill composite showed 13 cases with (Alpha) score and 4 cases with (Beta) score, respectively. The effect size (w) was 0.53. Using alpha (α) level of (5%) and Beta (β) level of (20%) i.e. power = 80%; the minimum estimated sample size was 28 cases. Sample size was increased to 35 cases to compensate for a drop-out rate of 25% after 12 months. Sample size calculation was performed using G*Power Version 3.1.9.2.
secondary outcome: This power analysis used hypersensitivity grades after one day in patient with medium cavity depth as the primary outcome. The effect sizes w1 = (1.4) and w2 = (1.11) were calculated based upon the results of Ragab H (2018). Using alpha (α) level of (5%) and Beta (β) level of (20%) i.e. power = 80%; the minimum estimated sample size was a total of 11 subjects. Sample size was increased to a total of 14 subjects (7 subjects per group) to compensate for a dropout rate of 25%. Sample size calculation was performed using G*Power Version 3.1.9.2

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
No pre-heating "control group"	Active comparator	Procedure: no pre-heating of resin composite before applicationresin composite is used at room temperature without preheating
0ne cycle pre-heating	Active comparator	Procedure: Pre-heating of resin composite before applicationone cycle preheating of resin composite at 68 degree Celsius before application
ten cycles pre-heating	Active comparator	Procedure: Pre-heating of resin composite before applicationten cycles preheating of resin composite at 68 degree Celsius before application

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

1- Moderate to deep proximal primary carious lesions" Class II" where each patient will have 2 "Class II" cavities on different sides.
2- Overall good oral hygiene status 3- Patients showing no signs of spontaneous dental or orofacial pain. 4- Selected teeth should not have any signs or symptoms of pulpal and periapical disease.
5- The selected teeth should have an occlusal contact with natural or crowned antagonist teeth, so that it could be tested for post-operative pain during chewing of food.
6- The selected teeth should have healthy gingival tissues, without gingival recession or alveolar bone loss.

Key exclusion criteria (8 listed)

1. Patients with a compromised medical history, or had received therapeutic irradiation to the head and neck region.
2. Acute and chronic systemic diseases, immune-compromised patients. 3. Medical problems preventing the participant from showing up to describe the presence of hypersensitivity 4. Alcoholic and smoker patients. 5. Pregnant or breastfeeding 6. Patients having physical disabilities, or who are unable to brush their teeth 7. Patients who have a history of allergies to any personal oral care product or ingredient, or who are taking anti-inflammatory drugs within the previous month.
8. Patients taking analgesics that could alter their normal pain perception level.
9. Medical, psychiatric, or pharmaco-therapeutic histories that might compromise the study protocol including chronic use of ant-inflammatory, analgesic, psychotropic drugs.
10. Individuals who had sensitive teeth but with one of the following conditions will be excluded from the study, teeth with large restorations, abutment of teeth of removable par¬tial dentures, dental caries, enamel cracks, leakage of fillings or other restorations, cracked teeth, dental pulp lesions, den¬tal abscesses, pulpitis, and atypical facial pain.

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
Pre-heating of resin composite before applicationthe effect of preheating of resin composite before application in class II cavities	Procedure or surgery	0ne cycle pre-heating, ten cycles pre-heating
no pre-heating of resin composite before applicationThe control group	Procedure or surgery	No pre-heating "control group"

Primary outcome

United States Public Health Service (USPHS) criteria
Time frame: 9 months
Clinical performance of the restorations tested for 9 months

1 secondary outcome

Post-Operative Dentin Hypersensitivity
Time frame: 1 month

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 28 Jul 2022.

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 8 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 28 Jul 2022. 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?

United States Public Health Service (USPHS) criteria (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05289479.

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 28 Jul 2022.