Evaluation of a Dental Trauma Care Program on the Oral Health-related Quality of Life in Children and Their Families
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Impact on oral heath related to quality of life from children and their families affected by traumatic dental injuries evaluated by B-ECOHIS instrument
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •parents/caregivers that refuse to answer the questionnaire at any point
- •parents/caregiversor who do not agree to sign the consent terms
研究组 & 干预措施
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 .
干预措施: TDI treatment (Procedure)
结局指标
主要结局
Impact on oral heath related to quality of life from children and their families affected by traumatic dental injuries evaluated by B-ECOHIS instrument
时间窗: 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.
次要结局
- 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)
研究者
Livia Azeredo Alves Antunes
Professor Lívia Azeredo Alves Antunes
Universidade Federal Fluminense