- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05666180
Impact of Complicated and Uncomplicated Traumatic Dental Injuries on Oral Health-related Quality of Life of a Group of Preschool Children and Their Families
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
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sara Abd Elraheem Abd Elmonem, bachelor
- Phone Number: 01148149772
- Email: sara.abdelreheem@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
|
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
Sponsor
Publications and helpful links
General Publications
- Pahel BT, Rozier RG, Slade GD. Parental perceptions of children's oral health: the Early Childhood Oral Health Impact Scale (ECOHIS). Health Qual Life Outcomes. 2007 Jan 30;5:6. doi: 10.1186/1477-7525-5-6.
- Antunes LAA, Milani AJ, Castilho T, Antunes LS. Impact of complicated and uncomplicated traumatic dental injuries on oral health-related quality of life of preschoolers and their family. Int J Burns Trauma. 2020 Aug 15;10(4):162-168. eCollection 2020.
- Glendor U, Halling A, Andersson L, Eilert-Petersson E. Incidence of traumatic tooth injuries in children and adolescents in the county of Vastmanland, Sweden. Swed Dent J. 1996;20(1-2):15-28.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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