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.
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.
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 group | Role | What they receive |
|---|---|---|
| Sectional matrix: Classic ring system | Experimental | Sectional matrix: Classic ring system (TOR VM, Moscow, Russia) Receives: Device: Sectional matrix: Classic ring system (TOR VM, Moscow, Russia) |
| BioFit Posterior Matrix System | Active comparator | BioFit Posterior Matrix System (Bioclear, Tacoma, Washington, USA). Receives: Device: BioFit Posterior Matrix System |
| Saddle system | Active comparator | Saddle 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.
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
- Proximal contact point with the aid of visual examination and 25-/50-/100-μm metal blades.
- 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.
- First posted13 Nov 2025
- Study start1 Jan 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Complex CariesStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona mahmoud Abd Elrahman, Cairo University
- Investigators
- Sherifa A Abd ElAziz, PhD, Study director, Cairo University
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 16157438Hickel 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 17262225Peumans 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 33512113Durr-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 30127197Esteves H, Correia A, Araujo F. Classification of extensively damaged teeth to evaluate prognosis. J Can Dent Assoc. 2011;77:b105.
PubMed 21975072Shaalan, 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07227688
- Acronym / sponsor ID
- RCT / Mona_international_2
- Conditions
- Complex Caries
- Keywords
- proximal anatomical form, precontoured sectional matrix, complex restorations, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 13 Nov 2025 (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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sectional matrix: Classic ring system | Experimental | Device: Sectional matrix: Classic ring system (TOR VM, Moscow, Russia)Sectional matrix: Classic ring system (TOR VM, Moscow, Russia) |
| BioFit Posterior Matrix System | Active comparator | Device: BioFit Posterior Matrix SystemBioFit Posterior Matrix System (Bioclear, Tacoma, Washington, USA). |
| Saddle system | Active comparator | Device: Saddle system (TOR VM, Moscow, Russia)Saddle system (TOR VM, Moscow, Russia) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Poor oral hygiene.
- Allergic history concerning methacrylates
- Evidence of parafunctional habits.
- Presence of malalignment of 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 |
|---|---|---|
| BioFit Posterior Matrix Systemprecontoured sectional matrix system | Device | BioFit Posterior Matrix System |
| Saddle system (TOR VM, Moscow, Russia)precontoured sectional matrix systems | Device | Saddle system |
| Sectional matrix: Classic ring system (TOR VM, Moscow, Russia)precontoured sectional matrix systems | Device | Sectional matrix: Classic ring system |
Primary outcome
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
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).
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 13 Nov 2025.
- BackgroundMarkose, D. Restoring proximal contacts of teeth. IOSR J Dent Med Sci. 2017; 16: 46-9.
- Background: PubMed 16157438Loomans 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.
- Background: PubMed 17262225Hickel 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.
- Background: PubMed 33512113Peumans 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.
- Background: PubMed 30127197Durr-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.
- Background: PubMed 21975072Esteves H, Correia A, Araujo F. Classification of extensively damaged teeth to evaluate prognosis. J Can Dent Assoc. 2011;77:b105.
- BackgroundShaalan, 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.
- Individual participant dataSharing planned: No
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.
Sherifa A Abd ElAziz, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
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.