Tooth DecayNCT06447324
Clinical and Radiographic Evaluation of Two Matrix Systems for Restoration of Class II Cavities in Primary Molars
A study testing Fender Mate matrix system and T-band matrix in people with Tooth Decay and Tooth Restoration, run by Aswan University.
Trial summary
this study aims to evaluate and compare the clinical and radiographical efficacy, operator ease, satisfaction and patient comfort in restoring class II cavities in primary molars using Fender Mate system with T-band system. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Decay, Tooth Restoration
- What is being tested?
- Fender Mate matrix system and T-band matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Oct 2024
- 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 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy children free from any systemic diseases.
- Patients showing Frankel's positive and definitely positive behavior.
- Parent willing to participate in the study and signed on informed consent.
- Each child has at least two carious primary molars (class II) bilaterally, indicated for composite restoration with criteria as follow: -
- No history of spontaneous pain or provoked pain.
- Fully erupted teeth.
Show all 10Show fewer
- Fully erupted adjacent tooth.
- Caries involving two surfaces - proximal and occlusal
- Absence of clinical signs or symptoms suggesting a non-vital tooth such as sinus tract, soft tissue swelling, mobility or tenderness to percussion.
- No pathological external or internal root resorption.
Who cannot join
- Patients showing Frankel's negative and definitely negative behavior.
- Children having primary molars with:
- Caries involving less than or more than two surfaces
- Extensively damaged teeth
- Missing adjacent tooth.
- Mobility.
- Spaced dentition.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Clinical, Radiographical Efficacy, Operator Ease and Satisfaction and Patient Comfort in Restoring Class II Cavities in Primary Molars With Fender Mate System Versus T-Band System: An in Vivo Study
this study aims to evaluate and compare the clinical and radiographical efficacy, operator ease, satisfaction and patient comfort in restoring class II cavities in primary molars using Fender Mate system with T-band system.
Read the detailed description
Restorations of posterior primary teeth can have a number of issues, including incorrect contact points and proximal overhangs. With the recognition of significance of restoring tooth's right contour and contact, and repair of all tooth surfaces, including proximal walls, different matrix systems were introduced,so this study aims to evaluate and compare the clinical and radiographical efficacy, operator ease, satisfaction and patient comfort in restoring class II cavities in primary molars using Fender Mate system with T-band system.
- Conditions
- Tooth Decay, Tooth Restoration
- Being tested
- Fender Mate matrix system, T-band matrix
- Keywords
- Matrix Systems, Class II Cavities, Primary Molars
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fender Mate matrix systemDevice
Matrix Systems used for Restoration of Class II Cavities in Primary Molars
T-band matrixDevice
Matrix Systems used for Restoration of Class II Cavities in Primary Molars
| Study group | Role | What they receive |
|---|---|---|
| Fender Mate matrix group | Experimental | Twenty primary molars will be restored with composite restoration using the Fender Mate matrix Receives: Device: Fender Mate matrix system |
| Conventional T-band matrix group | Experimental | Twenty primary molars will be restored with composite restoration using T-band matrix Receives: Device: T-band matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of Proximal Contact Points
clinically assessment of the Proximal Contact Points using waxed dental floss in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix.
Measured: Baseline
Radiographically Assessment of proximal overhangs
Radiographically Assessment of the proximal overhangs using bite wing radiograph in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix.
Measured: Baseline
Assessment of operator ease and satisfaction
-Assessment of operator ease and satisfaction using questionnaire in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix, which includes:
- time needed to install the matrix system (more time means worse outcome)
- Ease of application and removal of matrix system which may be Easy, Manageable or Difficult (Difficult means worse outcome)
- Trauma to gingival tissue while applying and removing matrix system which may be Present or Absent (Present means worse outcome)
- Dislodgment/displacement of restoration while removing matrix system which may be Yes or NO (Yes means worse outcome)
Measured: Baseline
Assessment of patient comfort
- Assessment of patient comfort using Wong Baker pain rating scale in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix.
- Wong Baker pain rating scale with scores from 0-10 (higher scores mean a worse outcome).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tooth DecayStudies of the same condition, open and under way.
- 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
- two groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Elsayed Fathi Abdou, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447324
- Sponsor's protocol ID
- matrix system for 1ry teeth
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dindukurthi MK, Setty JV, Srinivasan I, Melwani AM, Manasa Hegde K, Radhakrishna S. Restoration of Proximal Contacts in Decayed Primary Molars Using Three Different Matrix Systems in Children Aged 5-9 Years: An In Vivo Study. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):70-74. doi: 10.5005/jp-journals-10005-1929.
PubMed 34326587Bhatia HP, Sood S, Sharma N, Singh A, Rajagopal V. Comparative Evaluation of Clinical Efficiency and Patient Acceptability toward the Use of Circumferential Matrix and Sectional Matrix for Restoration of Class II Cavities in Primary Molars: An In Vivo Study. Int J Clin Pediatr Dent. 2021 Nov-Dec;14(6):748-751. doi: 10.5005/jp-journals-10005-2060.
PubMed 35110865Gomes IA, Filho EM, Mariz DC, Borges AH, Tonetto MR, Firoozmand LM, Kuga CM, De Jesus RR, Bandeca MC. In vivo Evaluation of Proximal Resin Composite Restorations performed using Three Different Matrix Systems. J Contemp Dent Pract. 2015 Aug 1;16(8):643-7. doi: 10.5005/jp-journals-10024-1735.
PubMed 26423500Abdou NEF, Said HRR, Abo-Elsoud AAE, Helmy YS. Clinical and radiographic evaluation of fendermate and T-band matrix systems for restoration of class II cavities in primary molars: a randomized clinical trial. BMC Oral Health. 2026 Mar 18;26(1):613. doi: 10.1186/s12903-026-07895-6.
PubMed 41851695
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical, Radiographical Efficacy, Operator Ease and Satisfaction and Patient Comfort in Restoring Class II Cavities in Primary Molars With Fender Mate System Versus T-Band System: An in Vivo Study
- ClinicalTrials.gov ID
- NCT06447324
- Acronym / sponsor ID
- matrix system for 1ry teeth
- Conditions
- Tooth Decay, Tooth Restoration
- Keywords
- Matrix Systems, Class II Cavities, Primary Molars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 7 Jun 2024 (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 aims to evaluate and compare the clinical and radiographical efficacy, operator ease, satisfaction and patient comfort in restoring class II cavities in primary molars using Fender Mate system with T-band system.
Detailed description
Restorations of posterior primary teeth can have a number of issues, including incorrect contact points and proximal overhangs. With the recognition of significance of restoring tooth's right contour and contact, and repair of all tooth surfaces, including proximal walls, different matrix systems were introduced,so this study aims to evaluate and compare the clinical and radiographical efficacy, operator ease, satisfaction and patient comfort in restoring class II cavities in primary molars using Fender Mate system with T-band system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups
| Arm | Type | Receives |
|---|---|---|
| Fender Mate matrix group | Experimental | Device: Fender Mate matrix systemTwenty primary molars will be restored with composite restoration using the Fender Mate matrix |
| Conventional T-band matrix group | Experimental | Device: T-band matrixTwenty primary molars will be restored with composite restoration using T-band matrix |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Apparently healthy children free from any systemic diseases.
- Patients showing Frankel's positive and definitely positive behavior.
- Parent willing to participate in the study and signed on informed consent.
- Each child has at least two carious primary molars (class II) bilaterally, indicated for composite restoration with criteria as follow: -
Key exclusion criteria (7 listed)
- Patients showing Frankel's negative and definitely negative behavior.
- Children having primary molars with:
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 |
|---|---|---|
| Fender Mate matrix systemMatrix Systems used for Restoration of Class II Cavities in Primary Molars | Device | Fender Mate matrix group |
| T-band matrixMatrix Systems used for Restoration of Class II Cavities in Primary Molars | Device | Conventional T-band matrix group |
Primary outcome
Clinical assessment of Proximal Contact Points
Time frame: Baseline
clinically assessment of the Proximal Contact Points using waxed dental floss in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix.
Radiographically Assessment of proximal overhangs
Time frame: Baseline
Radiographically Assessment of the proximal overhangs using bite wing radiograph in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix.
Assessment of operator ease and satisfaction
Time frame: Baseline
-Assessment of operator ease and satisfaction using questionnaire in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix, which includes: 1. time needed to install the matrix system (more time means worse outcome) 2. Ease of application and removal of matrix system which may be Easy, Manageable or Difficult (Difficult means worse outcome) 3. Trauma to gingival tissue while applying and removing matrix system which may be Present or Absent (Present means worse outcome) 4. Dislodgment/displacement of restoration while removing matrix system which may be Yes or NO (Yes means worse outcome)
Assessment of patient comfort
Time frame: Baseline
* Assessment of patient comfort using Wong Baker pain rating scale in restoring class II cavities in primary molars using Fender Mate system in comparison with conventional T-band matrix. * Wong Baker pain rating scale with scores from 0-10 (higher scores mean a worse outcome).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Results publication: PubMed 34326587Dindukurthi MK, Setty JV, Srinivasan I, Melwani AM, Manasa Hegde K, Radhakrishna S. Restoration of Proximal Contacts in Decayed Primary Molars Using Three Different Matrix Systems in Children Aged 5-9 Years: An In Vivo Study. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):70-74. doi: 10.5005/jp-journals-10005-1929.
- Results publication: PubMed 35110865Bhatia HP, Sood S, Sharma N, Singh A, Rajagopal V. Comparative Evaluation of Clinical Efficiency and Patient Acceptability toward the Use of Circumferential Matrix and Sectional Matrix for Restoration of Class II Cavities in Primary Molars: An In Vivo Study. Int J Clin Pediatr Dent. 2021 Nov-Dec;14(6):748-751. doi: 10.5005/jp-journals-10005-2060.
- Results publication: PubMed 26423500Gomes IA, Filho EM, Mariz DC, Borges AH, Tonetto MR, Firoozmand LM, Kuga CM, De Jesus RR, Bandeca MC. In vivo Evaluation of Proximal Resin Composite Restorations performed using Three Different Matrix Systems. J Contemp Dent Pract. 2015 Aug 1;16(8):643-7. doi: 10.5005/jp-journals-10024-1735.
- Derived from this study: PubMed 41851695Abdou NEF, Said HRR, Abo-Elsoud AAE, Helmy YS. Clinical and radiographic evaluation of fendermate and T-band matrix systems for restoration of class II cavities in primary molars: a randomized clinical trial. BMC Oral Health. 2026 Mar 18;26(1):613. doi: 10.1186/s12903-026-07895-6.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fender Mate matrix system and T-band matrix in people with Tooth Decay and Tooth Restoration, run by Aswan University.
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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha El-Sayed Fathi Abdou, Lecturer (01288737074 ext. 002, noha_elsayed1@dent.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of Proximal Contact Points (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT06447324, which also lists 4 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 10 Jun 2024.