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NCT05134714
"Evaluation of Clinical Performance and Success Rate of CAD/CAM Versus Conventional Band and Loop Space Maintainer"
NA trial testing CAD/CAM zircon band and loop space maintainer in CAD/CAM Space Maintainer in 18 participants. Status unknown.
1 November 2024
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 June 2024 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 December 2024 |
Drugs / interventions tested
- CAD/CAM zircon band and loop space maintainer
- Conventional metal band and loop space maintainer
Conditions studied
- CAD/CAM Space Maintainer — all drugs for CAD/CAM Space Maintainer →
Sponsor
Ain Shams University
Who can join
Adults 4 to 7, any sex, with CAD/CAM Space Maintainer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is to evaluate and compare CAD/CAM zircon space maintainer and conventional metal of band and loop space maintainers in terms of plaque deposits and gingival health and, the success rate of the appliances in terms of: survival time, cement loss and appliance breakage. And to compare both appliances in terms of patient satisfaction. This study consists of two parts: in vivo part (split mouth RCT) and in vitro part: In vivo study: Its sample size was found to be (36) cases (i.e. 18 case per group). Sample size calculation was performed using G\*Power version 3.1.9.7 Sample size will be increased by about 10% to compensate for the drop-out. In this in vivo study split mouth will be randomly divided into two groups: Group 1: Conventional metal band and loop space maintainer Group 2: CAD/CAM zircon band and loop space maintainer In vitro study: its sample size was found to be (24) samples (i.e. 8 samples per group). Sample size calculation was performed using G\*Power version 3.1.9.7 Sample size will be increased by about 10% to compensate for the drop-out. Grouping: The zirconia specimen divided randomly into three groups according to type of cements: Group 1: Self-adhesive resin cement Group 2: Resin-modified glass ionomer cement Group 3: Universal bioactive cement
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05134714 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
- Last refreshed: 31 January 2024
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