Class II Composite RestorationsNCT07862894
Ni-Ti Shape-Memory Versus Conventional Sectional Matrices Systems in Class II Composite Restorations: A Randomized Clinical Trial
A study testing Ni-Ti Shape-Memory Sectional Matrix System in people with Class II Composite Restorations, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this randomized controlled clinical trial is to evaluate and compare the clinical performance of a Ni-Ti shape-memory sectional matrix system versus a conventional sectional matrix system in Class II direct composite restorations. The study will specifically assess the following clinical parameters: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Class II Composite Restorations
- What is being tested?
- Ni-Ti Shape-Memory Sectional Matrix System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) requiring Class II composite restorations in posterior teeth.
- Good oral hygiene and periodontal health.
- No systemic conditions affecting oral health.
Who cannot join
- Patients with bruxism or parafunctional habits.
- Severe malocclusion interfering with proximal contacts.
- Allergy to dental materials used in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry Cairo university
Cairo, Cairo Governorate
Mahitab Ahmed Kamal, BDS, 01019679235, mahitab.kamal@dentistry.cu.edu.eg
Omnia Magdy Kamal, Lecturer of Conservative Denti, 01200055725, omnia.magdy@dentistry.cu.edu.eg
About this study
Official title: Clinical Performance of Ni-Ti Shape-Memory Versus Conventional Sectional Matrices Systems in Class II Composite Restorations: A Randomized Clinical Trial
The aim of this randomized controlled clinical trial is to evaluate and compare the clinical performance of a Ni-Ti shape-memory sectional matrix system versus a conventional sectional matrix system in Class II direct composite restorations.
The study will specifically assess the following clinical parameters:
Read more
- Proximal contact tightness
- Proximal contour quality
- Fracture and retention of the restoration
- Marginal adaptation These clinical parameters will be evaluated immediately after restoration placement and after a 1-year follow-up using standardized clinical assessment methods, including the FDI criteria, dental floss evaluation, and radiographic assessment, where applicable.
Fracture and retention, and marginal adaptation will be assessed according to predefined scoring criteria.
Read the detailed description
This study is a two-arm, parallel-group randomized clinical trial comparing a Ni-Ti shape-memory sectional matrix system with a conventional sectional matrix system for Class II composite restorations. Eligible participants requiring Class II direct composite restorations will be randomly allocated to one of the two intervention groups. The proximal contact tightness will be evaluated as the primary outcome, while proximal contour quality and other relevant clinical parameters will be assessed as secondary outcomes. Clinical assessments will be performed immediately after restoration placement and at 1-year follow-up.
- Conditions
- Class II Composite Restorations
- Being tested
- Ni-Ti Shape-Memory Sectional Matrix System
- Keywords
- Class II restorations; sectional matrix; Ni-Ti matrix; proximal contact tightness; proximal contour; randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ni-Ti Shape-Memory Sectional Matrix SystemDevice
Intervention 1 - Ni-Ti Shape-Memory Sectional Matrix System
Quickmat-Flex ultra-thin titanium sectional matrix band combined with a Ni-Ti shape-memory separation ring for restoration of Class II posterior composite cavities.
Intervention 2 - Conventional Sectional Matrix System
TOR VM stainless-steel sectional matrix system combined with a conventional separation ring for restoration of Class II posterior composite cavities.
| Study group | Role | What they receive |
|---|---|---|
| Ni-Ti Shape Memory Matrix System | Experimental | Participants will receive Class II composite restorations using a Quickmat-Flex ultra-thin titanium sectional matrix band combined with a Ni-Ti shape-memory separation ring. Receives: Device: Ni-Ti Shape-Memory Sectional Matrix System |
| Conventional Sectional Matrix System | Active comparator | Participants will receive Class II composite restorations using a conventional stainless-steel sectional matrix system (TOR VM) combined with a conventional separation ring. Receives: Device: Ni-Ti Shape-Memory Sectional Matrix System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal Contact Tightness
Proximal contact tightness will be evaluated according to the FDI criteria (item 8: approximal anatomical form). Clinical assessment will be performed using a dental floss test and calibrated metal blades (25-100 μm) to assess resistance at the proximal contact area. The outcome will be recorded according to the FDI grading scale (8.1-8.5), as described by Heintze et al. (2010).
Measured: Immediately After Restoration Placement (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Class II Composite RestorationsStudies 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
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahitab Ahmed Anwar Kamal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862894
- Sponsor's protocol ID
- Cons-MS-2026
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbassy KM, Elmahy WA, Holiel AA. Evaluation of the proximal contact tightness in class II resin composite restorations using different contact forming instruments: a 1-year randomized controlled clinical trial. BMC Oral Health. 2023 Oct 7;23(1):729. doi: 10.1186/s12903-023-03462-5.
PubMed 37805456
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Ni-Ti Shape-Memory Versus Conventional Sectional Matrices Systems in Class II Composite Restorations: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07862894
- Acronym / sponsor ID
- Cons-MS-2026
- Conditions
- Class II Composite Restorations
- Keywords
- Class II restorations; sectional matrix; Ni-Ti matrix; proximal contact tightness; proximal contour; randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 7 Oct 2026 (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.
The aim of this randomized controlled clinical trial is to evaluate and compare the clinical performance of a Ni-Ti shape-memory sectional matrix system versus a conventional sectional matrix system in Class II direct composite restorations.
The study will specifically assess the following clinical parameters:
- Proximal contact tightness
- Proximal contour quality
- Fracture and retention of the restoration
- Marginal adaptation These clinical parameters will be evaluated immediately after restoration placement and after a 1-year follow-up using standardized clinical assessment methods, including the FDI criteria, dental floss evaluation, and radiographic assessment, where applicable.
Fracture and retention, and marginal adaptation will be assessed according to predefined scoring criteria.
Detailed description
This study is a two-arm, parallel-group randomized clinical trial comparing a Ni-Ti shape-memory sectional matrix system with a conventional sectional matrix system for Class II composite restorations. Eligible participants requiring Class II direct composite restorations will be randomly allocated to one of the two intervention groups. The proximal contact tightness will be evaluated as the primary outcome, while proximal contour quality and other relevant clinical parameters will be assessed as secondary outcomes. Clinical assessments will be performed immediately after restoration placement and at 1-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Ni-Ti Shape Memory Matrix System | Experimental | Device: Ni-Ti Shape-Memory Sectional Matrix SystemParticipants will receive Class II composite restorations using a Quickmat-Flex ultra-thin titanium sectional matrix band combined with a Ni-Ti shape-memory separation ring. |
| Conventional Sectional Matrix System | Active comparator | Device: Ni-Ti Shape-Memory Sectional Matrix SystemParticipants will receive Class II composite restorations using a conventional stainless-steel sectional matrix system (TOR VM) combined with a conventional separation ring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥18 years) requiring Class II composite restorations in posterior teeth.
Key exclusion criteria (3 listed)
- Patients with bruxism or parafunctional habits.
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 |
|---|---|---|
| Ni-Ti Shape-Memory Sectional Matrix SystemIntervention 1 - Ni-Ti Shape-Memory Sectional Matrix System Quickmat-Flex ultra-thin titanium sectional matrix band combined with a Ni-Ti shape-memory separation ring for restoration of Class II posterior composite cavities. Intervention 2 - Conventional Sectional Matrix System TOR VM stainless-steel sectional matrix system combined with a conventional separation ring for restoration of Class II posterior composite cavities. | Device | Conventional Sectional Matrix System, Ni-Ti Shape Memory Matrix System |
Primary outcome
Proximal Contact Tightness
Time frame: Immediately After Restoration Placement (baseline)
Proximal contact tightness will be evaluated according to the FDI criteria (item 8: approximal anatomical form). Clinical assessment will be performed using a dental floss test and calibrated metal blades (25-100 μm) to assess resistance at the proximal contact area. The outcome will be recorded according to the FDI grading scale (8.1-8.5), as described by Heintze et al. (2010).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 37805456Abbassy KM, Elmahy WA, Holiel AA. Evaluation of the proximal contact tightness in class II resin composite restorations using different contact forming instruments: a 1-year randomized controlled clinical trial. BMC Oral Health. 2023 Oct 7;23(1):729. doi: 10.1186/s12903-023-03462-5.
- Study evaluating proximal contact tightness in Class II resin composite restorations using different contact-forming instruments in a 1-year randomized controlled clinical trial.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ni-Ti Shape-Memory Sectional Matrix System in people with Class II Composite Restorations, 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahitab Kamal, BDS Cairo University (01019679235, mahitab.kamal@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal Contact Tightness (time frame: Immediately After Restoration Placement (baseline)). 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 NCT07862894, which also lists 1 linked publication.
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 7 Oct 2026.