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

January 28, 2019 updated by: Bojan Petrovic, University of Novi Sad

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
274

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Dental Clinic of Vojvodina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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).
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
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Novi Sad

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bojan B Petrovic, PhD, Faculty of Medicine, Dental Clinic of Vojvodina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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