Clinical trial NCT03720925: Traumatic Dental Injuries Treatment and Oral Health Related to Quality of Life
Official title: Evaluation of a Dental Trauma Care Program on the Oral Health-related Quality of Life in Children and Their Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma Dental
Quality of Life
Keywords: oral heath
quality of life
tooth injuries
children
family
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 87
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this research was to assess the impact of Oral Health-Related Quality of Life (OHRQoL) on children and their families affected by Traumatic Dental Injury (TDI) after insertion into a Dental Trauma Care Program (DTCP). After a sample size calculation, this non-randomized clinical study was composed of a consecutive sample of 2 to 6-year-old children registered in the DTCP from 2012-2019. Parents/Caregivers were interviewed to fill up an OHRQoL questionnaire. The Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS) was applied (in form of an interview) to evaluate the impact of TDI on OHRQoL before, and after treatment. The scores of the B-ECOHIS were calculated using the additive method, summing the numeric response codes for each item. The Andreassen classification was used to determine the TDI. The patients were treated (minimally intervention/invasive intervention) according to TDI severity (uncomplicated/complicated). The Kolmogorov-Smirnov test was performed to evaluate the normality of the data to determine the use of parametric or non-parametric tests. Mean or median comparisons were made for items in the overall scale and subscale scores to compare B-ECOHIS total scale/subscales/domains before and after insertion in DTCP. The responsiveness was assessed by analyzing the change in the scores on the scales and subscales. The changes were calculated by subtracting the post-treatment scores from the before-treatment scores. Positive change scores indicate an improvement in OHRQoL, while negative scores indicate deterioration. TDI severity and treatment-associated were also evaluated.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact on oral heath related to quality of life from children and their families affected by traumatic dental injuries evaluated by B-ECOHIS instrument
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Nova Friburgo
country: Brazil
facility: Universidade Federal Fluminense
state: Rio De Janeiro
Study officials:
affiliation: Universidade Federal Fluminense
name: Livia A Antunes, PhD
role: PRINCIPAL_INVESTIGATOR
References: