Last reviewed · How we verify
NCT05351372
Validation of X-ray Protocols in Cleft Children
NA trial testing Ultra-low dose protocol in Evaluate CBCT Protocols in Subjective Image Quality in 72 participants. Completed in 18 May 2017.
18 May 2017
Quick facts
| Lead sponsor | Karolinska Institutet |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | diagnostic |
| Enrollment | 72 |
| Start date | 31 May 2016 |
| Primary completion | 18 May 2017 |
| Estimated completion | 18 May 2017 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Ultra-low dose protocol
- Standard dose protocol
Conditions studied
- Evaluate CBCT Protocols in Subjective Image Quality — all drugs for Evaluate CBCT Protocols in Subjective Image Quality →
Sponsor
Karolinska Institutet
Who can join
Eligibility, any sex, with Evaluate CBCT Protocols in Subjective Image Quality. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Children born with an alveolar cleft receive bone grafts for improved function and aesthetics. The cleft area is radiologically examined before and post bone graft. Optimizing x-ray examination protocols is essential to protect these patients from possible delayed radiation injury later in life. This study investigates whether image quality of cone-beam computed tomography (CBCT) exposed with an ultra-low dose (ULD) protocol is comparable to the clinical default protocol, the standard dose (SD) protocol, in visualizing details of importance in bone grafting of alveolar clefts. Methods In this randomized controlled study, 72 patients with uni- or bilateral alveolar clefts between 9-19 years (mean age 9.5) were randomized 1:1 with either a ULD or an SD CBCT examination protocol. The CBCT scans were conducted with Planmeca ProMax Mid with an 8x5cm field of view. Two experienced radiologists blindly evaluated the images and visibility of cortical bone border, trabecular bone, tooth anatomy, root development, periodontal space, and cleft width. The visibility was categorized as unacceptable, acceptable, or excellent.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05351372
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Karolinska Institutet trials
Trials by the same sponsor.
- NCT06359262 — Evaluating the Hope@School Prevention Program · NA · not yet recruiting
- NCT07289490 — Bilateral vs Unilateral Inguinal Hernia Repairs With an Asymptomatic Inguinal Hernia in Bilateral Hernias · NA · not yet recruiting
- NCT06894264 — Emotion Processing and Regulation in People With Intellectual Disability · NA · not yet recruiting
- NCT07494266 — Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited · NA · not yet recruiting
- NCT07442032 — Cardiovascular Phenotypes in Sepsis · not yet recruiting
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 NCT05351372 (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 Karolinska Institutet
- Last refreshed: 4 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05351372.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing