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

NCT06113770 | Unknown DMC

• 1 other identifier: 787/4375
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

, 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.

Conditions

Caries of Infancy

Outcome Measures

Primary Outcomes (1)

• Gingival condition

  Löe \& Silness gingival index

  in 6 months

Secondary Outcomes (1)

• gingival bleeding

  6 months

Study Arms (2)

ready made zirconia

EXPERIMENTAL

the selected tooth will receive ready made zirconia crown

Other: preparation of the tooth to receive ready made zirconia crown

pmma crown

EXPERIMENTAL

the selected tooth will receive cad cam custom made pmma crown

Other: preparation of the tooth to receive CAD CAM PMMA custom made crown

Interventions

preparation of the tooth to receive ready made zirconia crown OTHER

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 .

ready made zirconia

preparation of the tooth to receive CAD CAM PMMA custom made crown OTHER

* 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 .

pmma crown

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Adel Sherif Mostafa Rehab: lead

Study Sites (1)

AlAzharU

Cairo, Egypt

Location

Study Officials

• Adel S Rehab

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 2, 2023
• Study Start: May 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)