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

Quality of Life Clinical Trial

Official title:

Evaluation of a Dental Trauma Care Program on the Oral Health-related Quality of Life in Children and Their Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03720925
• Other study ID #: TDI treatment and OHRQoL
• Status: Completed
• Phase: N/A
• Start date: March 1, 2013
• Est. completion date: December 1, 2019

Study information

• Verified date: November 2022
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life
• Trauma Dental

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
Brazil	Universidade Federal Fluminense	Nova Friburgo	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	6 months