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

Sponsor

Adel Sherif Mostafa Rehab (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06113770

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caries of Infancy	Other: preparation of the tooth to receive ready made zirconia crown Other: preparation of the tooth to receive CAD CAM PMMA custom made crown	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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 .

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 .

Outcome Measures

Primary Outcome Measures

Gingival condition [in 6 months]
Löe & Silness gingival index

Secondary Outcome Measures

gingival bleeding [6 months]
Papilla Bleeding Index

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

A- Inclusion Criteria:

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.

B- Exclusion Criteria:-

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AlAzharU	Cairo		Egypt

Sponsors and Collaborators

Adel Sherif Mostafa Rehab

Investigators

Principal Investigator: Adel S Rehab, Al-Azhar University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adel Sherif Mostafa Rehab, Principal Investigator, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT06113770

Other Study ID Numbers:

787/4375

First Posted:

Nov 2, 2023

Last Update Posted:

Nov 3, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 3, 2023