Health TrialsbyHealthPanel

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

ConditionsTooth DecayTooth Restoration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-9
SponsorAswan University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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: -

Disqualifiers

Patients showing Frankel's negative and definitely negative behavior.

Caries involving less than or more than two surfaces

Extensively damaged teeth

Missing adjacent tooth.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fender Mate matrix system

    Device

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

  • T-band matrix

    Device

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Fender Mate matrix groupExperimental treatment 1 intervention
Group B: Conventional T-band matrix groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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: 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)

Time frame
Baseline
4

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).

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aswan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: