Clinical Performance and Convenience of Four Types of Crowns for Primary Molars
1 other identifier
interventional
80
1 country
2
Brief Summary
This study will be conducted to assess the clinical performance and convenience of three types of crowns as esthetic alternatives to stainless steel crown for primary molars:
- The prefabricated commercially available zirconia crowns (NuSmile®) (NZC).
- The locally manufactured zirconia crowns created via Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) system (CCZC).
- The locally manufactured hybrid ceramic crowns created via Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) system (CCHC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2024
CompletedFirst Submitted
Initial submission to the registry
May 19, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedJune 13, 2024
March 1, 2024
1.9 years
May 19, 2024
June 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
the gingival index
0 = normal gingiva 1. = mild inflammation 2. = moderate inflammation 3. = severe inflammation
12 months
Crown retention
0 = present. 1 = absent.
12 months
Crown integrity
0 = intact. 1. = crack present. 2. = fracture present. 3. = crown lost.
12 months
Color stability
0 = Unchanged. 1. = Minor deviation from original. 2. = Unacceptable discoloration.
12 months
Plaque Index
0 = no plaque 1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque.
12 months
Secondary Outcomes (1)
wear of opposing natural teeth.
12 months
Study Arms (4)
Stainless Steel Crown
ACTIVE COMPARATORcrown
• NuSmile zirconia crown
ACTIVE COMPARATORcrown
• CAD CAM zirconia crown
ACTIVE COMPARATORcrown
• CAD CAM hybrid crown
ACTIVE COMPARATORcrown
Interventions
primary molar crown type
Eligibility Criteria
You may qualify if:
- Children between 4-8 years old.
- Definitely positive or positive behavior according to Frankl behavior rating scale.
- The lower second primary molar with one or more indications for crown restoration.
You may not qualify if:
- The child does not have occlusal problems or periodontal diseases
- The child does not take medications that lead to symptoms of periodontal diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 002, Egypt
Mansoura university
Al Mansurah, Dakahlya, 002, Egypt
Related Publications (1)
Amer DM, Abdellatif AM. In vivo evaluation of the enamel wear of primary molar against four types of crowns using the intra-oral scanner. BMC Oral Health. 2024 Nov 27;24(1):1438. doi: 10.1186/s12903-024-05206-5.
PMID: 39604941DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Diana M Amer, MASTER
Mansoura University
- STUDY CHAIR
Abeer M Abdellatif, Phd
Mansoura University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2024
First Posted
June 13, 2024
Study Start
February 5, 2022
Primary Completion
January 17, 2024
Study Completion
May 17, 2024
Last Updated
June 13, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share