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

Intellectual Disabilities (F70-F79) Clinical Trial

— DTADGA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03823976
• Other study ID #: 01454/2018
• Status: Recruiting
• Start date: January 20, 2019
• Est. completion date: June 20, 2019

Study information

• Verified date: January 2019
• Source: University of Novi Sad
• Contact: Bojan B Petrovic, PhD
• Phone: +38163342639
• Email: bojan.petrovic[@]mf.uns.ac.rs
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 274
• Est. completion date: June 20, 2019
• Est. primary completion date: April 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intellectual Disabilities (F70-F79)
• Intellectual Disability

Intervention

Other:
• Types of the dental procedures in general anaesthesia
Analysis of the mean number of preventive, prophylactic, therapeutic and rehabilitation procedures

Locations

Country	Name	City	State
Serbia	Dental Clinic of Vojvodina	Novi Sad

Sponsors (1)

Lead Sponsor	Collaborator
University of Novi Sad

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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