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

NCT03720925 | Completed

• 1 other identifier: TDI treatment and OHRQoL
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Dental; Quality of Life

Keywords

oral heath; quality of life; tooth injuries; children; family

Outcome Measures

Primary Outcomes (1)

• Impact on oral heath related to quality of life from children and their families affected by traumatic dental injuries evaluated by B-ECOHIS instrument

  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.

  6 months

Secondary Outcomes (1)

• 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

  6 months

Study Arms (1)

TDI treatment

EXPERIMENTAL

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 .

Procedure: TDI treatment

Interventions

TDI treatment 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).

TDI treatment

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• parents/caregivers that refuse to answer the questionnaire at any point
• parents/caregiversor who do not agree to sign the consent terms

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Universidade Federal Fluminense

Nova Friburgo, Rio de Janeiro, 28625650, Brazil

Location

MeSH Terms

Conditions

Tooth Injuries

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries

Study Officials

• Livia A Antunes, PhD

  Universidade Federal Fluminense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Lívia Azeredo Alves Antunes

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 25, 2018
• Study Start: March 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

BR (1)