- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03720925
Traumatic Dental Injuries Treatment and Oral Health Related to Quality of Life
Evaluation of a Dental Trauma Care Program on the Oral Health-related Quality of Life in Children and Their Families
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It is recognized that measurements OHRQoL are essential strategies of oral health surveys, clinical trials, and studies evaluating the outcomes of preventive and therapeutic program. In the literature it is observed efficacy on OHRQoL outcomes focused on oral health education (OHE) associated to: atraumatic restorative treatment (ART), dental caries, gingivitis.
In the literature it is also seen that the presence of TDI is associated to negative impact on OHRQoL)that affects physical and psychosocial consequences for children and their families. The treatment of TDI is a challenge, that it is related to an improvement on famil and on children from 8 to 14 years and attended in a center of surveillance for TDI.
For a broader understanding of the consequences of outcomes of preventive and therapeutic program for TDI, it is important to expand the assessment of its performance using an OHRQoL measure for other ages of children.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio De Janeiro
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Nova Friburgo, Rio De Janeiro, Brazil, 28625650
- Universidade Federal Fluminense
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children aged from 2 to 6 years who suffered some type of TDI in the deciduous dentition
- healthy patients without disabilities
- children don't used interceptive orthodontic braces or prostheses
- TDI that occurred in the last 3 months before the first questionnaire application
- TDI treatment completed up to 3 months before the second questionnaire application
Exclusion Criteria:
- parents/caregivers that refuse to answer the questionnaire at any point
- parents/caregiversor who do not agree to sign the consent terms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TDI treatment
The TDI treatment was performed according to its complexity. Uncomplicated TDI received minimally invasive treatment (simple restorations and clinical and radiographic follow-up). Complicated TDI received invasive treatment (more complex restorations, endodontic treatment, confection of aesthetic devices, restraints). The Oral Health Related to Quality of Life assessment will be conducted before treatment (Baseline) and from between 3 to 6 months after the TDI treatment . |
The TDI treatment was performed according to its complexity.
Uncomplicated TDI received minimally invasive treatment (simple restorations and clinical and radiographic follow-up).
Complicated TDI received invasive treatment (more complex restorations, endodontic treatment, confection of aesthetic devices, restraints).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact on oral heath related to quality of life from children and their families affected by traumatic dental injuries evaluated by B-ECOHIS instrument
Time Frame: 6 months
|
The B-ECOHIS was applied (in form of interview).
This questionnaire is composed of 13 items distributed between a child impact section (CIS) and family impact section (FIS).
The first section has four subscales: symptoms, function, psychology and self-image/social interaction.
The FIS has two subscales: parental distress and family function.
Response categories of ECOHIS were coded on a five-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = often; 4 = very often.
All 'don't know' responses were recoded to "never".
The score for each domain is calculated through a simple sum of the scores of each item.
The total score ranges from 0 to 52.
After the TDI treatment a follow-up will be performed.
The changes were calculated by subtracting the appointment 2 (follow up) from the appointment 1 (initial exam).
Positive change scores indicate an improvement in OHRQoL, while negative scores indicate deterioration.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact on oral heath related to quality of life from children and their families affected by traumatic dental injuries according TDI severity and type of TDI treatment evaluated by B-ECOHIS instrument
Time Frame: 6 months
|
The B-ECOHIS was applied (in form of interview)and was used to evaluate the impact of the TDI according to its severity (complicated or uncomplicated) and type of treatment (minimally invasive or invasive).
This questionnaire is composed of 13 items distributed between a child impact section (CIS) and family impact section (FIS).
The first section has four subscales: symptoms, function, psychology and self-image/social interaction.
The FIS has two subscales: parental distress and family function.
Response categories of ECOHIS were coded on a five-point scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = often; 4 = very often.
All 'don't know' responses were recoded to "never".
The score for each domain is calculated through a simple sum of the scores of each item.
The total score ranges from 0 to 52, with higher scores denoting greater oral health impact and poorer OHRQoL.
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6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Livia A Antunes, PhD, Universidade Federal Fluminense
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TDI treatment and OHRQoL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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