Clinical Evaluation of Polymethyl Methacrylate CAD/CAM Crowns Versus Prefabricated Zirconia Crowns in Primary Molars

, in this studythe investigator will compare between ready-made zirconia crowns and Computer-aided design and Computer-aided manufacturing (CAD/CAM) polymethyl methacrylate (PMMA) crowns to overcome the disadvantages of ready-made zirconia crowns.

Study Overview

• Status: Active, not recruiting
• Conditions: Caries of Infancy
• Intervention / Treatment: Other: preparation of the tooth to receive ready made zirconia crown; Other: preparation of the tooth to receive CAD CAM PMMA custom made crown

• Study Type: Interventional
• Enrollment (Estimated): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • AlAzharU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

A- Inclusion Criteria:

1. Primary molars indicated for crown restoration (pulp treated molars indicated for crown
2. Co-operative child (Frankel scale +ve and ++ve)
3. The age ranged from 4 to 8 years regardless of sex or socioeconomic background.

B- Exclusion Criteria:-

1. Badly decayed non-restorable tooth indicated for extraction.
2. Patients with parafunctional habits like bruxism.
3. Systemic diseases with oral manifestation or blood diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ready made zirconia; the selected tooth will receive ready made zirconia crown	Other: preparation of the tooth to receive ready made zirconia crown; Occlusal reduction 1 to 2 mm using flame bur . Open the interproximal contacts. The tooth should be reduced circumferentially by approximately 0.5-1.5mm . The preparation margin should be carefully extended and refined to a feather-edge approximately 1-2mm subgingivally . Crown size will be determined using try in kit .
Experimental: pmma crown; the selected tooth will receive cad cam custom made pmma crown	Other: preparation of the tooth to receive CAD CAM PMMA custom made crown; Open the interproximal contacts .; The tooth should be reduced circumferentially by approximately 0.5-1mm .; The preparation margin should be carefully extended and refined to a feather- edge approximately 1-2mm subgingivally .; Rubber base impression will be taken by BMS additional silicone kit to the prepared tooth and will be sent to the laboratory to be scanned and to design the crown .; The final crown will be cemented using glass ionomer cement .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival condition	Löe & Silness gingival index	in 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival bleeding	Papilla Bleeding Index	6 months

Collaborators and Investigators

• Sponsor: Adel Sherif Mostafa Rehab
• Investigators: Principal Investigator: Adel S Rehab, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 28, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 787/4375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No