Dental LeakageNCT04679220
36-Months Clinical Evaluation of Preheated and Room Temperature Resin Composite
A study testing Preheating in people with Dental Leakage, run by Mansoura University at 1 site in Egypt.
Trial summary
Summary The aim of this study was to evaluate the effect of preheating resin composite (RC) on clinical performance of class I restorations in a period of 3-years using a split-mouth double-blinded randomized design. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Leakage
- What is being tested?
- Preheating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 30 Jun 2020
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with primary caries involving occlusal surface only with ICDAS 2 and 3
- Patients with cavities no more than one-third of the intercuspal distance
- Patients must have a good oral hygiene;
- Patients with tooth gives positive response to testing with an electric pulp tester
- Patients with normal and full occlusion,
- Patients with opposing teeth should be natural with no restorations.
Who cannot join
- High caries risk patients with extremely poor oral hygiene,
- Patients involved in orthodontic treatment or periodontal surgery,
- Patients with periodontally involved teeth (chronic periodontitis)
- Patients with abutments should be excluded.
- Patients with heavy bruxism habits and clenching
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 36-Months Clinical Evaluation of Preheated Resin Composite
Summary The aim of this study was to evaluate the effect of preheating resin composite (RC) on clinical performance of class I restorations in a period of 3-years using a split-mouth double-blinded randomized design.
Read the detailed description
The description of the experimental design followed the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the split mouth design. Thirty-five adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, University of Mansoura were enrolled in the current study with a total of 70 Class I restorations. No advertisement was made for participant recruitment, forming a sample of convenience. Each patient much sign a consent form before participating in the current study. The study was conducted from October 2017 to June 2020 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on the clinical success rate (100% retention rate at 3 years) of posterior class I restorations restored with nanofilled composite observed in a previous study.28 According to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. Upon these data, a sample size of 30 subjects was appropriate. Allowing for a 20% drop-out, sample size was set totalizing 35 subjects.
- Conditions
- Dental Leakage
- Being tested
- Preheating
- Keywords
- Resin Composite, Pain, Randomized Clinical Trial, Operative Dentistry, Preheating
- Medical subject headings
- Dental Leakage, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreheatingProcedure or surgery
For preheating RC prior to placement, a device called Therma-flo TM RC warming kit (Vista, Wisconsin, USA) was used according to manufacturer's instructions to preheat resin composites
| Study group | Role | What they receive |
|---|---|---|
| Non-heated Resin Composite group | Active comparator | Patients received Non-heated nanofilled resin composite on one side of the mouth Receives: Procedure: Preheating |
| Preheated Resin Composite group | Placebo comparator | Patients received preheated nanofilled resin composite on the other side of the mouth Receives: Procedure: Preheating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage % of patients with marginal staining
Percentage of marginal staining in patients was clinically assessed using World Dental Federation FDI parameters using a scale from 1 to 5 scores (clinically very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor)
Measured: 3 years after restoration procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Oct 2017
- Primary completion1 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental LeakageStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- One side of the mouth received preheated composite however in the other side the composite was placed in non-heated state following the manufacturer instructions.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679220
- Sponsor's protocol ID
- 36.MCEPRCRCL
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan can be shared to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 36-Months Clinical Evaluation of Preheated Resin Composite
- ClinicalTrials.gov ID
- NCT04679220
- Acronym / sponsor ID
- 36.MCEPRCRCL
- Conditions
- Dental Leakage
- Keywords
- Resin Composite, Pain, Randomized Clinical Trial, Operative Dentistry, Preheating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 Dec 2020 (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.
Summary The aim of this study was to evaluate the effect of preheating resin composite (RC) on clinical performance of class I restorations in a period of 3-years using a split-mouth double-blinded randomized design.
Detailed description
The description of the experimental design followed the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the split mouth design. Thirty-five adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, University of Mansoura were enrolled in the current study with a total of 70 Class I restorations. No advertisement was made for participant recruitment, forming a sample of convenience. Each patient much sign a consent form before participating in the current study. The study was conducted from October 2017 to June 2020 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on the clinical success rate (100% retention rate at 3 years) of posterior class I restorations restored with nanofilled composite observed in a previous study.28 According to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. Upon these data, a sample size of 30 subjects was appropriate. Allowing for a 20% drop-out, sample size was set totalizing 35 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- One side of the mouth received preheated composite however in the other side the composite was placed in non-heated state following the manufacturer instructions.
| Arm | Type | Receives |
|---|---|---|
| Non-heated Resin Composite group | Active comparator | Procedure: PreheatingPatients received Non-heated nanofilled resin composite on one side of the mouth |
| Preheated Resin Composite group | Placebo comparator | Procedure: PreheatingPatients received preheated nanofilled resin composite on the other side of the mouth |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with primary caries involving occlusal surface only with ICDAS 2 and 3
- Patients with cavities no more than one-third of the intercuspal distance
- Patients must have a good oral hygiene;
- Patients with tooth gives positive response to testing with an electric pulp tester
- Patients with normal and full occlusion,
Key exclusion criteria (5 listed)
- High caries risk patients with extremely poor oral hygiene,
- Patients involved in orthodontic treatment or periodontal surgery,
- Patients with periodontally involved teeth (chronic periodontitis)
- Patients with abutments should be excluded.
- Patients with heavy bruxism habits and clenching
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 |
|---|---|---|
| PreheatingFor preheating RC prior to placement, a device called Therma-flo TM RC warming kit (Vista, Wisconsin, USA) was used according to manufacturer's instructions to preheat resin composites | Procedure or surgery | Non-heated Resin Composite group, Preheated Resin Composite group |
Primary outcome
Percentage % of patients with marginal staining
Time frame: 3 years after restoration procedure
Percentage of marginal staining in patients was clinically assessed using World Dental Federation FDI parameters using a scale from 1 to 5 scores (clinically very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor)
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 22 Dec 2020.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan can be shared to other researchers
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?
A study testing Preheating in people with Dental Leakage, run by Mansoura University 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 6 inclusion and 5 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 22 Dec 2020. 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. Some participants in this study may receive a placebo. 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?
Percentage % of patients with marginal staining (time frame: 3 years after restoration procedure). 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 22 Dec 2020.