Clinical and Radiographic Evaluation of Two Matrix Systems for Restoration of Class II Cavities in Primary Molars

NCT ID: NCT06447324

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-10-30

Brief Summary

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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

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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

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Tooth Decay Tooth Restoration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Fender Mate matrix group

Twenty primary molars will be restored with composite restoration using the Fender Mate matrix

Group Type EXPERIMENTAL

Fender Mate matrix system

Intervention Type DEVICE

Matrix Systems used for Restoration of Class II Cavities in Primary Molars

Conventional T-band matrix group

Twenty primary molars will be restored with composite restoration using T-band matrix

Group Type EXPERIMENTAL

T-band matrix

Intervention Type DEVICE

Matrix Systems used for Restoration of Class II Cavities in Primary Molars

Interventions

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Fender Mate matrix system

Matrix Systems used for Restoration of Class II Cavities in Primary Molars

Intervention Type DEVICE

T-band matrix

Matrix Systems used for Restoration of Class II Cavities in Primary Molars

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Apparently healthy children free from any systemic diseases.
2. Patients showing Frankel's positive and definitely positive behavior.
3. Parent willing to participate in the study and signed on informed consent.
4. 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.
* 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.

Exclusion Criteria

1. Patients showing Frankel's negative and definitely negative behavior.
2. Children having primary molars with:

* Caries involving less than or more than two surfaces
* Extensively damaged teeth
* Missing adjacent tooth.
* Mobility.
* Spaced dentition.
Minimum Eligible Age

4 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aswan University

OTHER

Sponsor Role lead

Responsible Party

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Noha Elsayed Fathi Abdou

Lecturer at Pediatric Dentistry Department, Preventive Dentistry and Dental Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Noha El-Sayed Fathi Abdou, Lecturer

Role: CONTACT

01288737074 ext. 002

Asmaa Ali Emam Abo-Elsoud, Assoc. Prof

Role: CONTACT

01220989854 ext. 002

References

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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.

Reference Type RESULT
PMID: 34326587 (View on PubMed)

Bhatia 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.

Reference Type RESULT
PMID: 35110865 (View on PubMed)

Gomes 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.

Reference Type RESULT
PMID: 26423500 (View on PubMed)

Other Identifiers

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matrix system for 1ry teeth

Identifier Type: -

Identifier Source: org_study_id

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