Evaluation of Patients With Down Syndrome Compliance to Dental Therapy

NCT05755464 | Withdrawn DMC

• 1 other identifier: 1946
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Down Syndrome

Keywords

Down Syndrome; Dental disease; Compliance

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness of a module designed to evaluate the level of collaboration of the dental patient with DS.

  The aspects that, during the procedures, are indicative of the collaboration, translated into numerical values are counted.

  3 years

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study is expected to evaluate 100 Italian patients aged between 9 and 16 years with DS, who require an evaluation of dental malocclusion and orthodontic correction.

You may qualify if:

• Down Syndrome
• Need of Dental treatment
• malocclusion

You may not qualify if:

• other existing pathologies

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Down Syndrome; Stomatognathic Diseases; Patient Compliance

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• cristina Grippaudo

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 6, 2023
• Study Start: September 20, 2018
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: September 4, 2026

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)