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

Tooth Decay Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447324
• Other study ID #: matrix system for 1ry teeth
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: June 2024
• Source: Aswan University
• Contact: Noha El-Sayed Fathi Abdou, Lecturer
• Phone: 01288737074
• Email: noha_elsayed1[@]dent.suez.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Tooth Decay

Intervention

Device:
• Fender Mate matrix system
Matrix Systems used for Restoration of Class II Cavities in Primary Molars
• T-band matrix
Matrix Systems used for Restoration of Class II Cavities in Primary Molars

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University

References & Publications (3)

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 Stu — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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