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Complex CariesRCTNCT07227688

Evaluation of the Proximal Form of Precontoured Sectional Matrix in Complex Proximal Posterior Restorations

A study testing BioFit Posterior Matrix System, Saddle system (TOR VM, Moscow, Russia) and Sectional matrix: Classic ring system (TOR VM, Moscow, Russia) in people with Complex Caries, run by Cairo University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Evaluation of the proximal anatomical form quality of different precontoured sectional matrix systems in complex proximal posterior resin composite restorations using Fédération Dentaire Internationale' (FDI) clinical criteria for the evaluation of direct and indirect restorations Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Complex Caries
What is being tested?
BioFit Posterior Matrix System, Saddle system (TOR VM, Moscow, Russia) and Sectional matrix: Classic ring system (TOR VM, Moscow, Russia)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
1 Jan 2025to 1 Dec 2025
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 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients with posterior complex class II cavities to be restored with resin composite restorations.
  • 18 - 45 years.
  • Males or Females.
  • Good oral hygiene.
  • Co-operative patients approving to participate in the study.

Who cannot join

  • Poor oral hygiene.
  • Allergic history concerning methacrylates
  • Evidence of parafunctional habits.
  • Presence of malalignment of teeth

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo University

    Giza, GZ, 12345

Other trials in Egypt

About this study

Official title: Evaluation of the Proximal Anatomical Form Quality of Different Precontoured Sectional Matrix Systems in Complex Proximal Posterior Resin Composite Restorations: Randomized Clinical Trial.

Evaluation of the proximal anatomical form quality of different precontoured sectional matrix systems in complex proximal posterior resin composite restorations using Fédération Dentaire Internationale' (FDI) clinical criteria for the evaluation of direct and indirect restorations

Read the detailed description

The importance of the interdental anatomy of a class II direct composite restoration is one of the most underestimated topics in direct posterior composite restorations. The proximal emergence profile of the restoration and the contact area should be designed to maximize arch continuity and to minimize food impaction. A thorough knowledge of proper contacts and contours and how they ought to be duplicated as well as predisposing factors for proximal contact loss as proximal caries, embrasure size and position, and marginal ridge location and thickness, all of which contribute to achieving ideal occlusal harmony.

Conventional circumferential matrix systems produced poor proximal contact points with proximal overhangs or open contacts, and they failed to produce optimum contact points; thus, their usage should be prohibited.

It was found that, optimum contact points were highly associated with the sectional matrix system; there was a 70% lower risk for non- optimum contact points than the circumferential matrix system. Open and tight contacts were highly associated with the circumferential matrix system regardless of operator experience. Sectional matrix systems with separation rings should be implemented as the first choice in clinical decision making for proximal posterior restorations.

Although in vitro and in vivo studies showed that the use a contoured sectional metal matrix band with a separation rings results in optimum contact point and emergence profile, its use is technique sensitive due to rounded contours and thin thickness of matrices, which can cause a depression or bending in the matrix material during placement, rendering it unusable. Also, this matrix systems have shortcomings and does not give the expected result in all class II cavities. The variation in depth, width of the box, distance between the cervical cavity margin and the adjacent tooth requires customization of the interproximal space.

As the main objective is to recreate proximal contacts and contour that mimic the natural teeth making this area self-cleansable, preserving the periodontium, improving the restoration durability as well as maintaining the mesio-distal dimension of either dental arch. This mission is more complicated with badly broken-down teeth. By defining a badly destructed tooth we can say that it is a tooth that has lost a significant amount of tooth material which may be due to caries affection, fractures, or even extensive endo treatments. The result is that the remaining tooth structure becomes friable and weakened and presents a challenge during restoration due to increased distance between the cervical cavity margin and the adjacent tooth and the situation is more complicated if part of the buccal and lingual walls are missing making the ordinary sectional matrix liable to collapse after placing the separation rings.

classic ring system made by TOR VM was chosen as the comparator. Several innovative types of sectional matrix systems were introduced to the market with several thicknesses, heights, profiles of curvature, variation of wedges and separation clamps. These advancements have enabled dentists to create the most beneficial proximal contact surfaces and anatomically correct contours, both of which are critical for tooth periodontal complex protection.

In badly broken-down teeth, the sectional matrix should have a correct curved profile, making it possible to create a correct emergence profile in a cervico-occlusal direction. An increased proximal curvature (cervico-incisally) of the matrix band is required when the distance between the cervical cavity margin and the adjacent tooth increases. This is observed when the cervical cavity margin is in a more apical position. Thus, to select the correct matrix band, one must be aware of its maximum curvature. Besides the matrix bands should have enough extensions in a buccolingual direction to be able to restore the contact area efficiently.

Hard stainless steel sectional saddle matrices (TOR VM, Moscow, Russia) have a maximum curvature of ±0.7 mm compared to ±0.5 mm of the classical TORVM sectional matrix. The maximum curvature starts more cervically, making it easier to reach deeper margins. And these matrices offer more buccal and lingual wrap than traditional matrices.

The Bioclear Biofit matrices introduce new matrix technology and designs that claimed by the manufacturer to ensure ideal proximal composite contour. BioFit Matrix bands (Bioclear Matrix Systems; Tacoma, WA, USA) have the highest maximum curvature among all available matrices in the market (±0.9 mm). These matrix bands are contoured plastic (Mylar) sectional matrices with a placement tab that makes the matrix easy to place. Transparent matrices may allow better light transmission and allegedly more effective polymerization of the underlying resin composite. Mylar matrices also leave the composite more polished and contoured than traditional metal matrices which leave a more matte finish. In addition, the new shape of the Biofit matrices offers 30% more buccal/lingual and occlusal wrap than traditional matrices and can be used in cavities that are more open in a bucco-lingual direction. In addition, the matrix features a curved occlusal embrasure, which, if the matrix is well-positioned, shortens the finishing time of the occlusal embrasure with burs or disks.

The clinical performance of these matrices regarding obtaining optimum contact, contour and prevents overhangs is yet to be evaluated. Controlled randomized clinical trials- based on correctly adopted evaluation systems, are crucial for effective evidence-based dental knowledge and restorative practice. Thus, this study aims to contribute in providing evidence-based literature concerning current innovative matrixing systems and an evidence based clinical practice in the most critical situation which is restoring contacts in badly broken down teeth.

Conditions
Complex Caries
Being tested
BioFit Posterior Matrix System, Saddle system (TOR VM, Moscow, Russia), Sectional matrix: Classic ring system (TOR VM, Moscow, Russia)
Keywords
proximal anatomical form, precontoured sectional matrix, complex restorations, Randomized Clinical Trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioFit Posterior Matrix SystemDevice

    precontoured sectional matrix system

  • Saddle system (TOR VM, Moscow, Russia)Device

    precontoured sectional matrix systems

  • Sectional matrix: Classic ring system (TOR VM, Moscow, Russia)Device

    precontoured sectional matrix systems

Study groups in NCT07227688
Study groupRoleWhat they receive
Sectional matrix: Classic ring systemExperimentalSectional matrix: Classic ring system (TOR VM, Moscow, Russia)
Receives: Device: Sectional matrix: Classic ring system (TOR VM, Moscow, Russia)
BioFit Posterior Matrix SystemActive comparatorBioFit Posterior Matrix System (Bioclear, Tacoma, Washington, USA).
Receives: Device: BioFit Posterior Matrix System
Saddle systemActive comparatorSaddle system (TOR VM, Moscow, Russia)
Receives: Device: Saddle system (TOR VM, Moscow, Russia)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with a change in the proximal anatomical form using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations

    1. Proximal contact point with the aid of visual examination and 25-/50-/100-μm metal blades.
    2. Form and contour utilizing visual examination and radiographic assessment.

    For each criterion, one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).

    Measured: Immediately after restoration placement at the baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2025
  2. Study start1 Jan 2025
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07227688
Sponsor's protocol ID
Mona_international_2
Acronym
RCT
Status last verified
Nov 2025
First submitted
8 Nov 2025
Last updated
13 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Markose, D. Restoring proximal contacts of teeth. IOSR J Dent Med Sci. 2017; 16: 46-9.

  • Loomans BA, Opdam NJ, Roeters FJ, Bronkhorst EM, Burgersdijk RC, Dorfer CE. A randomized clinical trial on proximal contacts of posterior composites. J Dent. 2006 Apr;34(4):292-7. doi: 10.1016/j.jdent.2005.07.008. Epub 2005 Sep 12.

    PubMed 16157438
  • Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30.

    PubMed 17262225
  • Peumans M, Venuti P, Politano G, Van Meerbeek B. Effective Protocol for Daily High-quality Direct Posterior Composite Restorations. The Interdental Anatomy of the Class-2 Composite Restoration. J Adhes Dent. 2021;23(1):21-34. doi: 10.3290/j.jad.b916819.

    PubMed 33512113
  • Durr-E-Sadaf; Ahmad MZ, Gaikwad RN, Arjumand B. Comparison of two different matrix band systems in restoring two surface cavities in posterior teeth done by senior undergraduate students at Qassim University, Saudi Arabia: A randomized controlled clinical trial. Indian J Dent Res. 2018 Jul-Aug;29(4):459-464. doi: 10.4103/ijdr.IJDR_26_17.

    PubMed 30127197
  • Esteves H, Correia A, Araujo F. Classification of extensively damaged teeth to evaluate prognosis. J Can Dent Assoc. 2011;77:b105.

    PubMed 21975072
  • Shaalan, O. O., & Ibrahim, S. H. (2021). Clinical evaluation of sectional matrix versus circumferential matrix for reproduction of proximal contact by undergraduate students and postgraduate dentists: A randomized controlled trial. Journal of International Oral Health, 13(1), 10.

Questions about this trial

What is this clinical trial studying?

A study testing BioFit Posterior Matrix System, Saddle system (TOR VM, Moscow, Russia) and Sectional matrix: Classic ring system (TOR VM, Moscow, Russia) in people with Complex Caries, 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2025. 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?

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?

Number of participants with a change in the proximal anatomical form using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations (time frame: Immediately after restoration placement at the 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 NCT07227688, which also lists 7 linked publications.

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 Nov 2025.

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