Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583759
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
EVALUATION OF PREFABRICATED CADCAM PEEK CROWNS USED IN PRIMARY MOLARS A RANDOMISED CONTROLLED CLINICAL TRIAL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EVALUATION OF PREFABRICATED CADCAM PEEK CROWNS USED IN PRIMARY MOLARS A RANDOMISED CONTROLLED CLINICAL TRIAL
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fifty healthy cooperative children will be randomly allocated to two groups Group I test group will receive CADCAM PEEK crowns while group II control group will receive SSC The crowns will be evaluated clinically and radiographically
Detailed Description:
A two-arm randomized controlled clinical trial A total of 50 healthy children aged 5-7 years will be selected from Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry Alexandria University Egypt Children will be selected with scores 3 or 4 Frankl behavioral rating scale Each child selected will have at least one mandibular second primary molar indicated for full coverage Written informed consent will be obtained from their guardians Participants will be randomly allocated into two groups according to the crown that will be used Group I test group will receive CADCAM PEEK crowns while group II control group will receive SSC Using Modified Ryges Criteria the crowns will be examined clinically for anatomic form restoration staining marginal discoloration colour match surface roughness marginal adaptation proximal contact occlusal wear of crown wear of opposing tooth and presence of cracks Gingival and Plaques index scores will be recorded as well as chairside time patient and parental satisfaction The patients will be recalled at 1 week then 3 6 and 12 months for clinical follow-up Radiographs will be taken at 6 and 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None