NCT03823976

Brief Summary

This study evaluates the types of dental procedures performed in general anaesthesia for adult persons with intellectual disability, as well as factors affecting the decision to perform the dental treatment in general anaesthesia, factors contributing to tooth loss and possibilities to perform oral rehabilitation procedures

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

January 20, 2019

Last Update Submit

January 28, 2019

Conditions

Keywords

dental careoral rehabilitationgeneral anaesthesiatooth loss

Outcome Measures

Primary Outcomes (2)

  • Tooth loss analysis calculated as T fraction in DMFT teeth after the procedure

    The analysis of the mean number of extracted teeth per patient during dental procedure in general anaesthesia. Correlations (odds-ratios) between the level of ID, the presence of comorbidities, institutionalisation and tooth loss

    3 months

  • Oral rehabilitation analysis calculated as care index (CI), defined as the number of restored teeth as a fraction of the total number of decayed (D), missing (M) and filled (F) teeth (CI= F/DMF × 100).

    The analysis of oral rehabilitation procedures performed during general anaesthesia.Correlations (odds-ratios) between the level of ID, the presence of comorbidities, institutionalisation and the level of CI

    6months

Interventions

Analysis of the mean number of preventive, prophylactic, therapeutic and rehabilitation procedures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study includes all patients older than 18 years that have been treated in general anesthesia between 2008 and 2018 at the Dentistry Clinic of Vojvodina, Serbia. Study gathered data from medical documentation of procedures which was obtained patient's/parents'/caregivers' consent for.

You may qualify if:

  • Participants with ID older than 18 years at the time of treatment in GA
  • Participants who had at least one general anesthesia dental treatment.

You may not qualify if:

  • Participants who had dental treatment in GA due to physical condition, without ID
  • Participants younger than 18,
  • Participants with ID who had never had treatment in GA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Clinic of Vojvodina

Novi Sad, 21000, Serbia

RECRUITING

MeSH Terms

Conditions

Intellectual DisabilityTooth Loss

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Bojan B Petrovic, PhD

    Faculty of Medicine, Dental Clinic of Vojvodina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bojan B Petrovic, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2019

First Posted

January 31, 2019

Study Start

January 20, 2019

Primary Completion

April 20, 2019

Study Completion

June 20, 2019

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations