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NCT05755464
Evaluation of Patients With Down Syndrome Compliance to Dental Therapy
trial in Down Syndrome in 100 participants. Suspended.
20 September 2021
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Suspended |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 20 September 2018 |
| Primary completion | 20 September 2021 |
| Estimated completion | 20 September 2024 |
| Sites | 1 location across Italy |
Conditions studied
- Down Syndrome — all drugs for Down Syndrome →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
Adults 9 to 16, any sex, with Down Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Since subjects with Down Syndrome (DS) have different and variable levels of intellectual deficit, in approaching the patient with DS and before evaluating the different therapeutic strategies and carrying out a dental and orthodontic treatment, an initial analysis would be useful the patient's level of cooperation. The hypothesis underlying the study is the possibility of predicting the degree of success of dental and orthodontic treatment in the patient with Down's Syndrome by completing an evaluation form by the clinician. The general objective of the study is to test the effectiveness of the module in assessing and quantifying the degree of patient collaboration. This form is filled in entirely during the first visit and updated in subsequent sessions in conjunction with the different operational phases. Based on the score obtained by the patient, the clinician can hypothesize the degree of cooperation during the operative sessions and compliance with the indications provided. Therefore, the evaluation of the score obtained will guide the clinician in choosing the type of therapy that will have the least risk of failure because this will be chosen having evaluated not only the dental and/or orthodontic therapeutic needs, but also the real ability of the patient to collaborate.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05755464
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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 NCT05755464 (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 Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 6 March 2023
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/NCT05755464.
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