Dental Treatment and Oral Rehabilitation for Adult Individuals With Intellectual Disability in General Anaesthesia (DTADGA)

A Pattern of Dental Treatment and Oral Rehabilitation for Adult Individuals With Intellectual Disability in General Anaesthesia

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

Study Overview

• Status: Unknown
• Conditions: Intellectual Disabilities (F70-F79)
• Intervention / Treatment: Other: Types of the dental procedures in general anaesthesia

Detailed Description

Oral diseases are not life threatening and dental procedures usually do not pose significant risk to a patient. In situation where a patient does not tolerate dental treatment, and consequently general anaethesia (GA) is used, an intellectually disabled (ID) patient with a condition that is routinely managed in the general population is exposed to significantly higher medical risk. Quality of oral health care delivery for adults with ID is considered inadequate and in need of constant improvement. Therefore, the present study aims to analyse the type of dental treatment performed in GA and factors affecting the treatment. By its design this is an observational, epidemiological, retrospective study. A representative sample of the target population is realised by the assessment of approximately n=250 ID adults treated at the Dental Clinic of Vojvodina. A number of parameters such as severity of ID, the presence of concomitant conditions, living arrangements, medical diagnoses, physical status according to the American Society of Anesthesiologists' classification (ASA score), history of previous surgical/GA treatments and injuries/trauma, frequency of dental visits, procedures that were conducted in GA and during routine dental treatment (RDT), dental status including DMFT (decay, missed, filled teeth index) and total number of extracted teeth and data about oral rehabilitation.The use of GA emphasizes the inequalities in persons with ID, since it is always more radical compared to RDT. It is a frequent occurrence that with the use of GA only prevention of complications and pain relief are accomplished, resulting in a multiple teeth extractions. This approach inevitably leads to further dysfunctions in cranio-facial system, affecting all aspects of everyday life in persons with ID.

• Study Type: Observational
• Enrollment (Anticipated): 274

Contacts and Locations

Study Locations

• Serbia
  • Novi Sad, Serbia, 21000
    • Recruiting
    • Dental Clinic of Vojvodina
    • Contact: Bojan B Petrovic, PhD; Phone Number: 17 +38121612222; Email: bojan.petrovic@mf.uns.ac.rs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Novi Sad
• Investigators: Principal Investigator: Bojan B Petrovic, PhD, Faculty of Medicine, Dental Clinic of Vojvodina

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2019
• Primary Completion (ANTICIPATED): April 20, 2019
• Study Completion (ANTICIPATED): June 20, 2019

Study Registration Dates

• First Submitted: January 20, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (ACTUAL): January 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: general anaesthesia; dental care; tooth loss; oral rehabilitation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 01454/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No