Dental LeakageNCT05383768
Clinical Evaluation of Preheated and Repeated Preheated Versus Conventional Bulk Fill Resin Composite
A study testing preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C in people with Dental Leakage, run by Cairo University at 1 site in Egypt.
Trial summary
A Randomized clinical trial to evaluate the clinical Performance of Posterior Restorations of Bulk Fill Resin Composite without Preheating Versus Repeated Preheating for One, Five and Ten times .The null hypothesis of this study is that there is no significant difference in clinical performance of the restoration… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Leakage
- What is being tested?
- preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Apr 2023
- 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
- a)Inclusion Criteria of participants
- Patient age between (18-60) years old.
- Patient is capable of informed consent. 3-Patients with a high level of oral hygiene.
- b)Inclusion Criteria of teeth:
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- vital teeth
- Carious molar teeth.
Who cannot join
- a)Exclusion criteria of participants
- Participants with general systematic illness.
- Experience with allergic reactions against any component of used materials.
- Concomitant participation in another research study.
- Patients receiving Orthodontic treatment.
- Pregnant or lactating females.
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- patient with heavy Bruxism habits.
- b)Exclusion criteria of the teeth
- <!-- -->
- The tooth to be filled is an abutment tooth for a removable prosthesis.
- The tooth to be filled is periodontally involved (grade 2 or grade 3 mobile).
- Endodontically treated tooth.
- tooth with previous restoration
- Exposed tooth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Posterior Restorations of Bulk Fill Resin Composite Without Preheating Versus Repeated Preheating for One, Five and Ten Times: A Randomized Controlled Clinical Trial
A Randomized clinical trial to evaluate the clinical Performance of Posterior Restorations of Bulk Fill Resin Composite without Preheating Versus Repeated Preheating for One, Five and Ten times .The null hypothesis of this study is that there is no significant difference in clinical performance of the restoration during restoring posterior teeth when using bulk-fill without preheating and after repeated preheating for one , five and ten times in restoration of posterior teeth.
Read the detailed description
Dental resin composites are widely used for adhesive restorative procedures nowadays due to the significant improvement in their physical and mechanical properties. However, volumetric shrinkage is still an inherent drawback of the polymerization of the resin matrix .
Preheating improves adaptation, polymerization shrinkage and degree of conversion without affect mechanical properties of resin composite restorations.
In clinical situation, composite resin syringe is repeatedly used for restoration of several cavities and if preheating is applied, this syringe will undergo several heating cycles so repeated preheating effect on composite resin should be tested.
Follow up Period will be 1 year , Evaluation will be done at 3,6,9 and 12 months .
- Conditions
- Dental Leakage
- Being tested
- preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C
- Medical subject headings
- Dental Leakage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦COther
Intervention 1: restoration with one-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020).
Intervention 2: Restoration with five time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020).
Intervention 3: Restoration with ten time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020).
| Study group | Role | What they receive |
|---|---|---|
| Restoration with conventional no heated bulk-fill resin composite | Placebo comparator | Restoration with conventional no heated bulk-fill resin composite, X-tra fill (VOCO, GERMANY) Receives: Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C |
| restoration with one-time preheated conventional bulk-fill resin composite | Active comparator | restoration with one-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C Receives: Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C |
| restoration with five-time preheated conventional bulk-fill resin composite | Active comparator | restoration with five-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C Receives: Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C |
| restoration with ten-time preheated conventional bulk-fill resin composite | Active comparator | restoration with ten-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C Receives: Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C |
What is being measured
The primary outcome is the main question the study is designed to answer.
(marginal integrity) using Modified US Public Health Service Criteria (USPHS)
Clinical Evaluation of restoration (marginal integrity) using Modified US Public Health Service Criteria (USPHS)
Measured: one year
Secondary outcomes (1)
(Marginal discoloration, secondary caries and Postoperative Sensitivity) using Modified US Public Health Service Criteria (USPHS)
Clinical Evaluation of restoration (Marginal discoloration, secondary caries and Postoperative Sensitivity) using Modified US Public Health Service Criteria (USPHS)
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 posted20 May 2022
- Study start1 Mar 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
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 Cairo 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Ibrahim Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383768
- Sponsor's protocol ID
- 20322
- Status last verified
- May 2024
- First submitted
- 13 May 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Posterior Restorations of Bulk Fill Resin Composite Without Preheating Versus Repeated Preheating for One, Five and Ten Times: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05383768
- Acronym / sponsor ID
- 20322
- Conditions
- Dental Leakage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 20 May 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.
A Randomized clinical trial to evaluate the clinical Performance of Posterior Restorations of Bulk Fill Resin Composite without Preheating Versus Repeated Preheating for One, Five and Ten times .The null hypothesis of this study is that there is no significant difference in clinical performance of the restoration during restoring posterior teeth when using bulk-fill without preheating and after repeated preheating for one , five and ten times in restoration of posterior teeth.
Detailed description
Dental resin composites are widely used for adhesive restorative procedures nowadays due to the significant improvement in their physical and mechanical properties. However, volumetric shrinkage is still an inherent drawback of the polymerization of the resin matrix .
Preheating improves adaptation, polymerization shrinkage and degree of conversion without affect mechanical properties of resin composite restorations.
In clinical situation, composite resin syringe is repeatedly used for restoration of several cavities and if preheating is applied, this syringe will undergo several heating cycles so repeated preheating effect on composite resin should be tested.
Follow up Period will be 1 year , Evaluation will be done at 3,6,9 and 12 months .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Restoration with conventional no heated bulk-fill resin composite | Placebo comparator | Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦CRestoration with conventional no heated bulk-fill resin composite, X-tra fill (VOCO, GERMANY) |
| restoration with one-time preheated conventional bulk-fill resin composite | Active comparator | Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦Crestoration with one-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C |
| restoration with five-time preheated conventional bulk-fill resin composite | Active comparator | Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦Crestoration with five-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C |
| restoration with ten-time preheated conventional bulk-fill resin composite | Active comparator | Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦Crestoration with ten-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- a)Inclusion Criteria of participants
- <!-- -->
Key exclusion criteria (14 listed)
- a)Exclusion criteria of participants
- b)Exclusion criteria of the teeth
- <!-- -->
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 |
|---|---|---|
| preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦CIntervention 1: restoration with one-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020). Intervention 2: Restoration with five time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020). Intervention 3: Restoration with ten time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020). | Other | Restoration with conventional no heated bulk-fill resin composite, restoration with five-time preheated conventional bulk-fill resin composite, restoration with one-time preheated conventional bulk-fill resin composite, restoration with ten-time preheated conventional bulk-fill resin composite |
Primary outcome
(marginal integrity) using Modified US Public Health Service Criteria (USPHS)
Time frame: one year
Clinical Evaluation of restoration (marginal integrity) using Modified US Public Health Service Criteria (USPHS)
1 secondary outcome
(Marginal discoloration, secondary caries and Postoperative Sensitivity) using Modified US Public Health Service Criteria (USPHS)
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 29 May 2024.
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 preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C in people with Dental Leakage, run by Cairo 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 7 inclusion and 14 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 29 May 2024. 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?
(marginal integrity) using Modified US Public Health Service Criteria (USPHS) (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 29 May 2024.