Clinical trial NCT03823976: Dental Treatment and Oral Rehabilitation for Adult Individuals With Intellectual Disability in General Anaesthesia
Official title: A Pattern of Dental Treatment and Oral Rehabilitation for Adult Individuals With Intellectual Disability in General Anaesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intellectual Disabilities (F70-F79)
Keywords: dental care
oral rehabilitation
general anaesthesia
tooth loss
Lead sponsor: University of Novi Sad
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tooth loss analysis calculated as T fraction in DMFT teeth after the procedure
timeFrame: 3 months
measure: 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).
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Dental Clinic of Vojvodina
Study officials:
affiliation: Faculty of Medicine, Dental Clinic of Vojvodina
name: Bojan B Petrovic, PhD
role: PRINCIPAL_INVESTIGATOR
References: