Clinical trial NCT06447324: Clinical and Radiographic Evaluation of Two Matrix Systems for Restoration of Class II Cavities in Primary Molars
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tooth Decay
Tooth Restoration
Keywords: Matrix Systems
Class II Cavities
Primary Molars
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical assessment of Proximal Contact Points
timeFrame: Baseline
measure: Radiographically Assessment of proximal overhangs
timeFrame: Baseline
measure: Assessment of operator ease and satisfaction
timeFrame: Baseline
measure: Assessment of patient comfort
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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 Jan-Feb;14(1):70-74. doi: 10.5005/jp-journals-10005-1929.
citation: 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.
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. doi: 10.5005/jp-journals-10024-1735.