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

NCT06447324 | Not Yet Recruiting

• 1 other identifier: matrix system for 1ry teeth
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tooth Decay; Tooth Restoration

Keywords

Matrix Systems; Class II Cavities; Primary Molars

Outcome Measures

Primary Outcomes (4)

• 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: 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)

  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

Study Arms (2)

Fender Mate matrix group

EXPERIMENTAL

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

Device: Fender Mate matrix system

Conventional T-band matrix group

EXPERIMENTAL

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

Device: T-band matrix

Interventions

Fender Mate matrix system DEVICE

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

Fender Mate matrix group

T-band matrix DEVICE

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

Conventional T-band matrix group

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University: lead

Related Publications (3)

• 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.

  PMID: 34326587 RESULT

• 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.

  PMID: 35110865 RESULT

• 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.

  PMID: 26423500 RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Noha El-Sayed Fathi Abdou, Lecturer

CONTACT

01288737074; noha_elsayed1@dent.suez.edu.eg

Asmaa Ali Emam Abo-Elsoud, Assoc. Prof

CONTACT

01220989854; asmaa_ali@dent.suez.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Pediatric Dentistry Department, Preventive Dentistry and Dental Public Health

Model Details: two groups

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 7, 2024
• Study Start: July 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 30, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06