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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03823976
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Information provided by (Responsible Party):
Bojan Petrovic, University of Novi Sad

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

Condition or disease Intervention/treatment
Intellectual Disabilities (F70-F79) 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.

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Study Type : Observational
Estimated Enrollment : 274 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Pattern of Dental Treatment and Oral Rehabilitation for Adult Individuals With Intellectual Disability in General Anaesthesia
Actual Study Start Date : January 20, 2019
Estimated Primary Completion Date : April 20, 2019
Estimated Study Completion Date : June 20, 2019

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

Primary Outcome Measures :
  1. Tooth loss analysis calculated as T fraction in DMFT teeth after the procedure [ Time Frame: 3 months ]
    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

  2. 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). [ Time Frame: 6months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03823976

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Contact: Bojan B Petrovic, PhD +38163342639

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Dental Clinic of Vojvodina Recruiting
Novi Sad, Serbia, 21000
Contact: Bojan B Petrovic, PhD    +38121612222 ext 17   
Sponsors and Collaborators
University of Novi Sad
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Principal Investigator: Bojan B Petrovic, PhD Faculty of Medicine, Dental Clinic of Vojvodina

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Responsible Party: Bojan Petrovic, Principal Investigator, University of Novi Sad Identifier: NCT03823976     History of Changes
Other Study ID Numbers: 01454/2018
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bojan Petrovic, University of Novi Sad:
dental care
oral rehabilitation
general anaesthesia
tooth loss

Additional relevant MeSH terms:
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Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Central Nervous System Depressants
Physiological Effects of Drugs