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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tooth Decay; Tooth Restoration
• Intervention / Treatment: Device: Fender Mate matrix system; Device: T-band matrix

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noha El-Sayed Fathi Abdou, Lecturer; Phone Number: 002 01288737074; Email: noha_elsayed1@dent.suez.edu.eg
• Study Contact Backup: Name: Asmaa Ali Emam Abo-Elsoud, Assoc. Prof; Phone Number: 002 01220989854; Email: asmaa_ali@dent.suez.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fender Mate matrix group; Twenty primary molars will be restored with composite restoration using the Fender Mate matrix	Device: Fender Mate matrix system; Matrix Systems used for Restoration of Class II Cavities in Primary Molars
Experimental: Conventional T-band matrix group; Twenty primary molars will be restored with composite restoration using T-band matrix	Device: T-band matrix; Matrix Systems used for Restoration of Class II Cavities in Primary Molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	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).	Baseline

Collaborators and Investigators

• Sponsor: Aswan University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: June 2, 2024
• First Submitted That Met QC Criteria: June 2, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Primary Molars; Matrix Systems; Class II Cavities
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: matrix system for 1ry teeth

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No