Traumatic Dental Injuries Treatment and Oral Health Related to Quality of Life

NCT ID: NCT03720925

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-01
• Study Completion Date: 2019-12-01

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.

Conditions

Trauma Dental; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 .

Group Type: EXPERIMENTAL

TDI treatment

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal Fluminense

OTHER

Sponsor Role: lead

Responsible Party

Livia Azeredo Alves Antunes

Professor Lívia Azeredo Alves Antunes

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Livia A Antunes, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal Fluminense

Locations

Universidade Federal Fluminense

Nova Friburgo, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

TDI treatment and OHRQoL

Identifier Type: -

Identifier Source: org_study_id