Impact of Complicated and Uncomplicated Traumatic Dental Injuries on Oral Health-related Quality of Life of a Group of Preschool Children and Their Families

December 18, 2022 updated by: Sara Abd Elraheem Abd Elmonem, Cairo University

Impact of Complicated and Uncomplicated Traumatic Dental Injuries on Oral Health-Related Quality of Life of a Group of Preschool Children and Their Families: Cross-sectional Study

Evaluation of Impact of Complicated and Uncomplicated Traumatic Dental Injuries on Oral Health-Related Quality of Life in a Group of Preschool Children and Their Families.

Study Overview

Status

Not yet recruiting

Detailed Description

Statement of the problem Traumatic dental injury (TDI) is a current issue in public health (Milani et al, 2019). About one-third of children worldwide suffer from traumatic dental injuries (TDI), it has epidemiological significance. Throughout the child's growth and development, new and repetitive trauma may happen, influencing the dental, periodontal, bone, and soft tissue structures (Carneiro et al, 2020).

In young children, enamel fracture is the most frequent tooth injury, and this kind of trauma could go undetected by the child's parents, caregivers, or anybody else. The deciduous dentition has received a little amount of research on trauma (Carneiro et al, 2020).

Depending on the intensity of the consequences, dental trauma can have a significant impact on a child's life. It can cause discomfort and trouble chewing, as well as alter dento-facial aesthetics and, consequently, the person's ability to connect socially (Carneiro et al, 2020).

Systematic reviews have found that TDI affects pre-schoolers' oral health-related quality of life (OHRQoL). Children and their families suffer emotional and social consequences as a result (Antunes et al, 2020), (Zaror et al, 2018).

Risk factors, the impact of TDI, and the relation between TDI and socioeconomic status should all be considered (Antunes et al, 2020).

The purpose of this study is to assess the impact of dental trauma on children's and their families' oral health-related quality of life (OHRQoL), considering clinical and socioeconomic factors.

Rationale TDI cannot be anticipated and frequently requires emergency care due to its nature. Although it can happen at any age, the majority of TDI occurs in children. Literature reviews indicate that TDIs affect between one-third and one-fourth of kids in the primary dentition age range [(Jadav& Abbott, 2022), (Almeida et al, 2021)].

Due to the anatomical proximity of the germs of the permanent successors and the potential for adverse sequelae in both dentitions, TDI in the deciduous dentition requires extra care and attention. Therefore, the severity and extent of TDI can have an impact on the development of permanent successors as well as the prognosis of deciduous teeth (Antunes et al, 2020), (Andreasen et al, 2018).

Settings

• Location: preschool Nurseries in some rural areas in Elmaadi- Cairo.

  • Methodology:
  • Preschool children whose age ranged from 2 to yonger than 6 in some nurseries will be examined for traumatic dental injuries in anterior teeth.
  • Examination will be performed in a room under natural light, with the help of wooden spatulas and gauze, by a single, trained and calibrated examiner.
  • Type of tooth and the severity of TDI will be classified according to Glendor classification (Glendor et al, 1996) and will be recorded.
  • The classification of Glenndor: Uncomplicated tooth injuries: in which the pulpal tissue are not exposed and/ or tooth is not dislocated. And Complicated tooth injuries: in which the pulpal tissue are exposed and/ or tooth is dislocated
  • The author then will apply ECOHIS questionnaire on parents of children exposed to TDI after acceptance of informed consent.
  • The questionnaire was developed by (Pahel et al, 2007)
  • The questionnaire was then translated into Arabic and validated by (Nada Farsi et al, 2017).

Study Type

Observational

Enrollment (Anticipated)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with traumatized primary teeth whose age ranges from 2<6, whose parents accept participation in study.

Description

Inclusion Criteria:

  • Children with traumatized primary teeth whose age ranges from 2<6, whose parents accept participation in study.

Exclusion Criteria:

  • Children with mixed dentition.
  • Children who presented absence of anterior teeth due to natural exfoliation
  • Presence of crown defects not due to trauma.
  • Children with previous orthodontic treatment or undergoing this treatment at the time of the study.
  • Children with systemic or neuromotor diseases or had difficulties with communication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Impact of Complicated and Uncomplicated Traumatic Dental Injuries on Oral Health-Related Quality of Life in a Group of Preschool Children and Their Families.
Time Frame: 12 months

ECO HIS Questionnaire ECOHIS scores from 0 to 5

Codes:

0 = never

  1. = hardly ever
  2. = occasionally
  3. = often
  4. = very often
  5. = don't know
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of affected teeth in dentally traumatized preschool children
Time Frame: 12 months
By clinical examination
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

December 18, 2022

First Submitted That Met QC Criteria

December 18, 2022

First Posted (Estimate)

December 26, 2022

Study Record Updates

Last Update Posted (Estimate)

December 26, 2022

Last Update Submitted That Met QC Criteria

December 18, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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