Primary Molars Restoration Using CAD/CAM Crowns.

• Sponsor: Ahmad Elheeny (Other)
• Overall Status: Completed
• CT.gov ID: NCT04144062
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 8.1

Study Details

Study Description

Brief Summary

study aims to compare hybrid ceramic CAD/CAM and prefabricated zirconia crowns restoring primary molars through In-vivo evaluation of the clinical outcomes in terms of; treatment failure, amount of tooth wear in the opposing tooth and gingival health

Condition or Disease	Intervention/Treatment	Phase
Restoration of Primary Molars With CAD/CAM Crowns	Other: CAD/CAM crowns	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: CAD/CAM Crowns Versus Prefabricated Zirconia Crowns for Restoration of Primary Molars: A Prospective Study.
• Actual Study Start Date: Nov 25, 2019
• Actual Primary Completion Date: Feb 20, 2021
• Actual Study Completion Date: Feb 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Zirconia crowns	Other: CAD/CAM crowns; CAD/CAM crowns
Active Comparator: CAD/CAM crowns	Other: CAD/CAM crowns; CAD/CAM crowns

Outcome Measures

Primary Outcome Measures

1. clinical success [1 year]

   United States Public Health Service (USPHS) index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age range of the patients from 4 to 7 years old.

2. Have no history of spontaneous pain or swelling.

3. Patients willing to return for follow-up examinations and evaluation.

4. Medically free patients or with controlled systemic disease ASA I or II.

5. No active periodontal diseases.

6. Patients with posterior pulpotomized tooth/teeth indicated for crown restoration (e.g. 2-3mm of teeth above cement-enamel junction).

Exclusion Criteria:

1. Age range of the patients from 4 to 7 years old.

2. Have no history of spontaneous pain or swelling.

3. Patients willing to return for follow-up examinations and evaluation.

4. Medically free patients or with controlled systemic disease ASA I or II.

5. No active periodontal diseases.

6. Patients with posterior pulpotomized tooth/teeth indicated for crown restoration (e.g. 2-3mm of teeth above cement-enamel junction).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmad Elheeny	Minya		Egypt	61111

Sponsors and Collaborators

• Ahmad Elheeny

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmad Elheeny, Clinical professor, Minia University
• ClinicalTrials.gov Identifier: NCT04144062
• Other Study ID Numbers: 318
• First Posted: Oct 30, 2019
• Last Update Posted: Feb 25, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmad Elheeny, Clinical professor, Minia University: Crowns; Zirconium; Computer-Aided Design

Study Results

No Results Posted as of Feb 25, 2021