Dental Caries Class IINCT06137989
Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites
A study testing Fill-Up Class ӀӀ restoration, QuiXfil Class ӀӀ restoration and Tetric N-Ceram Bulk Fill Class ӀӀ restoration in people with Dental Caries Class II, run by Mansoura University at 1 site in Egypt.
Trial summary
This study (a double-blinded, prospective, randomized clinical trial) aimed to evaluate 2-year clinical performance of dual- and light-cure bulk-fill resin composites in Class ӀӀ restorations. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Dental Caries Class II
- What is being tested?
- Fill-Up Class ӀӀ restoration, QuiXfil Class ӀӀ restoration and Tetric N-Ceram Bulk Fill Class ӀӀ restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Aug 2020to 30 Aug 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- each participant should have at least three permanent molars and premolars that need to be treated with Class II restorations due to primary carious lesions.
- all participants required to have a full and normal occlusion and to maintain adequate oral hygiene.
Who cannot join
- General exclusion criteria:
- heavy bruxism.
- poor oral hygiene.
- chronic or severe periodontitis.
- a history of allergies to any of the materials utilized in this study.
- pregnant or nursing females.
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- Specific exclusion criteria:
- fractured or visibly cracked teeth.
- rampant caries.
- faulty restoration opposite or adjacent to the tooth to be restored.
- atypical extrinsic staining.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
Al Mansurah, Aldakhlia, 35516
About this study
Official title: Two-year Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites in Class ӀӀ Restorations: A Randomized Clinical Trial
This study (a double-blinded, prospective, randomized clinical trial) aimed to evaluate 2-year clinical performance of dual- and light-cure bulk-fill resin composites in Class ӀӀ restorations.
The null hypothesis tested in this study was that, there would be no difference in the 2-year clinical performance of all tested bulk-fill resin composites in Class II restorations.
Forty patients were enrolled in the study. Each patient received three bulk-fill resin composites Class ӀӀ restorations. One dual-cure and two light-cure bulk-fill resin composites were used for Class ӀӀ restorations following manufacturer's instructions. A universal adhesive was used with all restorations. All restorations were clinically evaluated after 1 week (baseline), 6 months, 12 months, 18 months and finally after 24 months using the FDI World Dental Federation criteria.
- Conditions
- Dental Caries Class II
- Being tested
- Fill-Up Class ӀӀ restoration, QuiXfil Class ӀӀ restoration, Tetric N-Ceram Bulk Fill Class ӀӀ restoration
- Keywords
- Bulk-fill resin composite, Dual-cure, Light-cure, Class ӀӀ restorations, Clinical performance, Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fill-Up Class ӀӀ restorationProcedure or surgery
Bulk-fill technique
QuiXfil Class ӀӀ restorationProcedure or surgery
Bulk-fill technique
Tetric N-Ceram Bulk Fill Class ӀӀ restorationProcedure or surgery
Bulk-fill technique
| Study group | Role | What they receive |
|---|---|---|
| Fill-Up | Active comparator | Bulk-fill resin composite type Receives: Procedure: Fill-Up Class ӀӀ restoration |
| QuiXfil | Active comparator | Bulk-fill resin composite type Receives: Procedure: QuiXfil Class ӀӀ restoration |
| Tetric N-Ceram Bulk Fill | Active comparator | Bulk-fill resin composite type Receives: Procedure: Tetric N-Ceram Bulk Fill Class ӀӀ restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esthetic properties (FDI criteria)
Including five parameters (surface luster, margin staining, surface staining, color match \& translucency, and esthetic anatomical form).
Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome.
Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).
Measured: From baseline to 2-year follow-up
Functional properties (FDI criteria)
Including five parameters (marginal adaptation, occlusal wear, proximal contact, radiographic examination, and fracture of material \& retention).
Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome.
Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).
Measured: From baseline to 2-year follow-up
Biological properties (FDI criteria)
Including three parameters (post-operative sensitivity, recurrence of caries, and tooth integrity).
Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome.
Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).
Measured: From baseline to 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start4 Aug 2020
- Primary completion20 Aug 2022
- Study completion30 Aug 2022
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
- Each patient received three Class ӀӀ restorations with the three tested bulk-fill resin composites.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elshirbeny Mohamed Elawsya, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137989
- Sponsor's protocol ID
- A01150620
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-year Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites in Class ӀӀ Restorations: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06137989
- Acronym / sponsor ID
- A01150620
- Conditions
- Dental Caries Class II
- Keywords
- Bulk-fill resin composite, Dual-cure, Light-cure, Class ӀӀ restorations, Clinical performance, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 18 Nov 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 study (a double-blinded, prospective, randomized clinical trial) aimed to evaluate 2-year clinical performance of dual- and light-cure bulk-fill resin composites in Class ӀӀ restorations.
The null hypothesis tested in this study was that, there would be no difference in the 2-year clinical performance of all tested bulk-fill resin composites in Class II restorations.
Forty patients were enrolled in the study. Each patient received three bulk-fill resin composites Class ӀӀ restorations. One dual-cure and two light-cure bulk-fill resin composites were used for Class ӀӀ restorations following manufacturer's instructions. A universal adhesive was used with all restorations. All restorations were clinically evaluated after 1 week (baseline), 6 months, 12 months, 18 months and finally after 24 months using the FDI World Dental Federation criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Each patient received three Class ӀӀ restorations with the three tested bulk-fill resin composites.
| Arm | Type | Receives |
|---|---|---|
| Fill-Up | Active comparator | Procedure: Fill-Up Class ӀӀ restorationBulk-fill resin composite type |
| QuiXfil | Active comparator | Procedure: QuiXfil Class ӀӀ restorationBulk-fill resin composite type |
| Tetric N-Ceram Bulk Fill | Active comparator | Procedure: Tetric N-Ceram Bulk Fill Class ӀӀ restorationBulk-fill resin composite type |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- each participant should have at least three permanent molars and premolars that need to be treated with Class II restorations due to primary carious lesions.
- all participants required to have a full and normal occlusion and to maintain adequate oral hygiene.
Key exclusion criteria (11 listed)
- heavy bruxism.
- poor oral hygiene.
- chronic or severe periodontitis.
- a history of allergies to any of the materials utilized in this study.
- pregnant or nursing females.
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 |
|---|---|---|
| Fill-Up Class ӀӀ restorationBulk-fill technique | Procedure or surgery | Fill-Up |
| QuiXfil Class ӀӀ restorationBulk-fill technique | Procedure or surgery | QuiXfil |
| Tetric N-Ceram Bulk Fill Class ӀӀ restorationBulk-fill technique | Procedure or surgery | Tetric N-Ceram Bulk Fill |
Primary outcome
Esthetic properties (FDI criteria)
Time frame: From baseline to 2-year follow-up
Including five parameters (surface luster, margin staining, surface staining, color match \& translucency, and esthetic anatomical form). Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome. Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).
Functional properties (FDI criteria)
Time frame: From baseline to 2-year follow-up
Including five parameters (marginal adaptation, occlusal wear, proximal contact, radiographic examination, and fracture of material \& retention). Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome. Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).
Biological properties (FDI criteria)
Time frame: From baseline to 2-year follow-up
Including three parameters (post-operative sensitivity, recurrence of caries, and tooth integrity). Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome. Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).
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 18 Nov 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.
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 Fill-Up Class ӀӀ restoration, QuiXfil Class ӀӀ restoration and Tetric N-Ceram Bulk Fill Class ӀӀ restoration 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 2 inclusion and 11 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 18 Nov 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?
Esthetic properties (FDI criteria) (time frame: From baseline to 2-year follow-up). The study lists 3 primary outcomes in all. 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 18 Nov 2023.