Dental Caries Class IINCT06032689
A 2-year Clinical Impact of Bulk-fill Low-viscosity Resin Composite Liners in Class II Restorations.
A study testing Xtra-fill, x-base and Admira fusion x-tra in people with Dental Caries Class II, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized clinical trial evaluated the clinical performance of class II resin composite restorations using bulk-fill high-viscosity ormocer versus methacrylate-based with or without a thin layer of bulk-fill low-viscosity (flowable) resin composite liners (BLRC) over 2 years. Read more about this study
- Who is it for?
- Ages 18 to 33 years
- Conditions the study is for
- Dental Caries Class II
- What is being tested?
- Xtra-fill, x-base and Admira fusion x-tra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2020to 17 Jun 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 33 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients having at least 4 posterior teeth with moderate occlusal-proximal carious lesions.
- Patients ranging in age from 18 to 30 years.
- patients with normal occlusion.
Who cannot join
- General exclusion criteria:
- Patients having severe chronic periodontitis.
- Patients with orthodontic appliances.
- Abnormal occlusion, parafunctional habits.
- Allergy to any of the materials used in the study. Specific teeth exclusion criteria
- Teeth with irreversible pulpitis or non-vital.
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- Fractured or cracked teeth.
- Previously restored teeth.
- Cavities with isthmus larger than intercuspal distance.
- Teeth with deep sub-gingival cavity margins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-Years Clinical Performance of Bulk-Fill High Viscosity Ormocer Versus Methacrylate-Based Resin Composite Restorative Systems: The Effect of Bulk-Fill Low-viscosity Resin Composite Liners in Class II Restorations.
This randomized clinical trial evaluated the clinical performance of class II resin composite restorations using bulk-fill high-viscosity ormocer versus methacrylate-based with or without a thin layer of bulk-fill low-viscosity (flowable) resin composite liners (BLRC) over 2 years. The null hypotheses in the study were as follows: (1) Different types of matrix structures (ormocer vs. methacrylate) have no effect on the marginal integrity of restorations; (2) A layer of bulk-fill resin compo-site liner of the same category would not affect the marginal or internal adaptation of restorations.
Read the detailed description
The study was designed following the Consolidated Standards of Reporting Trials (CONSORT) statement. approvement by the local ethics committee of Mansoura University code register was taken code M 11120520. The patients were selected as they searched for treatment in the Conservative Dentistry Department outpatient clinic, in the Faculty of Dentistry, Mansoura University. A group of 30 patients 21 Females and 9 males was chosen from among 92 participants after careful consideration of the inclusion and exclusion criteria. The sample size estimate was made based on the clinical success rate of posterior class II composite restorations observed in a prior study (97.5% at 24 months). The sample size needed per group was 23 teeth using a significance level of 0.05, power of 80%, and equivalency limit of 15%. A total of 30 patients were chosen, for a total of 120 restorations (30 for each group) after taking potential dropouts into account. To ensure adherence of the participants to the study, all volunteers underwent complete dental treatment and periodic follow-ups. The volunteers were contacted by telephone, WhatsApp message, Facebook, and e-mail for the assessments. Four attempts, including visits to the schools, were made to contact a volunteer before he/she was considered a "loss." both participants and examiners were blind to the interventions. An inter-examiner and intra-examiner agreement of at least 90% was requested before the beginning of the evaluation. Clinical evaluation was performed one week after finishing and polishing (baseline), after 6 months, 12 months, 18 months, and 24 months using the World Dental Federation (FDI) criteria.
- Conditions
- Dental Caries Class II
- Being tested
- Xtra-fill, x-base, Admira fusion x-tra, Admira fusion x-base
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xtra-fillCombination product
the material was placed in bulk.
x-baseCombination product
The x-base liner was placed and then veneered with Xtra-fill.
Admira fusion x-traCombination product
bulk placement of the restoration Admira fusion -xtra.
Admira fusion x-baseCombination product
Admira fusion x-base liner was used and then veneered by Admira fusion x-tra.
| Study group | Role | What they receive |
|---|---|---|
| Xtra-fill | Active comparator | Bulk-fill high-viscosity methacrylate-based resin composites. Receives: Combination Product: Xtra-fill |
| X-base | Active comparator | Bulk-fill low-viscosity methacrylate-based resin composites. Receives: Combination Product: x-base |
| Admira fusion x-tra | Active comparator | Bulk-fill high-viscosity ormocer-based resin composites. Receives: Combination Product: Admira fusion x-tra |
| Admira fusion x-base | Active comparator | Bulk-fill low-viscosity ormocer-based resin composites. Receives: Combination Product: Admira fusion x-base |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical performance
FDI criteria
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 Jan 2020
- Primary completion27 Apr 2022
- Study completion17 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries Class IIStudies 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
- Parallel groups
- Model description
- participants had at least four class II cavities in a split-mouth design and randomly each cavity was restored using one of four strategies( groups applied)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sa Mahmoud, professor, Principal investigator, Operative Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032689
- Sponsor's protocol ID
- M 11120520
- Status last verified
- Sep 2023
- First submitted
- 2 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Years Clinical Performance of Bulk-Fill High Viscosity Ormocer Versus Methacrylate-Based Resin Composite Restorative Systems: The Effect of Bulk-Fill Low-viscosity Resin Composite Liners in Class II Restorations.
- ClinicalTrials.gov ID
- NCT06032689
- Acronym / sponsor ID
- M 11120520
- Conditions
- Dental Caries Class II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 17 Jun 2023 (actual)
- First posted
- 13 Sep 2023 (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.
This randomized clinical trial evaluated the clinical performance of class II resin composite restorations using bulk-fill high-viscosity ormocer versus methacrylate-based with or without a thin layer of bulk-fill low-viscosity (flowable) resin composite liners (BLRC) over 2 years. The null hypotheses in the study were as follows: (1) Different types of matrix structures (ormocer vs. methacrylate) have no effect on the marginal integrity of restorations; (2) A layer of bulk-fill resin compo-site liner of the same category would not affect the marginal or internal adaptation of restorations.
Detailed description
The study was designed following the Consolidated Standards of Reporting Trials (CONSORT) statement. approvement by the local ethics committee of Mansoura University code register was taken code M 11120520. The patients were selected as they searched for treatment in the Conservative Dentistry Department outpatient clinic, in the Faculty of Dentistry, Mansoura University. A group of 30 patients 21 Females and 9 males was chosen from among 92 participants after careful consideration of the inclusion and exclusion criteria. The sample size estimate was made based on the clinical success rate of posterior class II composite restorations observed in a prior study (97.5% at 24 months). The sample size needed per group was 23 teeth using a significance level of 0.05, power of 80%, and equivalency limit of 15%. A total of 30 patients were chosen, for a total of 120 restorations (30 for each group) after taking potential dropouts into account. To ensure adherence of the participants to the study, all volunteers underwent complete dental treatment and periodic follow-ups. The volunteers were contacted by telephone, WhatsApp message, Facebook, and e-mail for the assessments. Four attempts, including visits to the schools, were made to contact a volunteer before he/she was considered a "loss." both participants and examiners were blind to the interventions. An inter-examiner and intra-examiner agreement of at least 90% was requested before the beginning of the evaluation. Clinical evaluation was performed one week after finishing and polishing (baseline), after 6 months, 12 months, 18 months, and 24 months using the World Dental Federation (FDI) criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- participants had at least four class II cavities in a split-mouth design and randomly each cavity was restored using one of four strategies( groups applied)
| Arm | Type | Receives |
|---|---|---|
| Xtra-fill | Active comparator | Combination Product: Xtra-fillBulk-fill high-viscosity methacrylate-based resin composites. |
| X-base | Active comparator | Combination Product: x-baseBulk-fill low-viscosity methacrylate-based resin composites. |
| Admira fusion x-tra | Active comparator | Combination Product: Admira fusion x-traBulk-fill high-viscosity ormocer-based resin composites. |
| Admira fusion x-base | Active comparator | Combination Product: Admira fusion x-baseBulk-fill low-viscosity ormocer-based resin composites. |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients having at least 4 posterior teeth with moderate occlusal-proximal carious lesions.
- Patients ranging in age from 18 to 30 years.
- patients with normal occlusion.
Key exclusion criteria (10 listed)
- Patients having severe chronic periodontitis.
- Patients with orthodontic appliances.
- Abnormal occlusion, parafunctional habits.
- Allergy to any of the materials used in the study. Specific teeth exclusion criteria
- Teeth with irreversible pulpitis or non-vital.
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 |
|---|---|---|
| Xtra-fillthe material was placed in bulk. | Combination product | Xtra-fill |
| x-baseThe x-base liner was placed and then veneered with Xtra-fill. | Combination product | X-base |
| Admira fusion x-trabulk placement of the restoration Admira fusion -xtra. | Combination product | Admira fusion x-tra |
| Admira fusion x-baseAdmira fusion x-base liner was used and then veneered by Admira fusion x-tra. | Combination product | Admira fusion x-base |
Primary outcome
clinical performance
Time frame: two years
FDI criteria
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 13 Sep 2023.
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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.
Sa Mahmoud, professor principal investigator
Operative Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xtra-fill, x-base and Admira fusion x-tra in people with Dental Caries Class II, 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 3 inclusion and 10 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 13 Sep 2023. 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?
clinical performance (time frame: two years). 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 13 Sep 2023.