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Clinical Trials/NCT06447324
NCT06447324
Not yet recruiting
Not Applicable

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

Aswan University0 sites20 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tooth Decay
Sponsor
Aswan University
Enrollment
20
Primary Endpoint
Clinical assessment of Proximal Contact Points
Status
Not yet recruiting
Last Updated
last year

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
October 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Noha Elsayed Fathi Abdou

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

Aswan University

Eligibility Criteria

Inclusion Criteria

  • 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.
  • 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

  • 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.

Outcomes

Primary Outcomes

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).

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