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Traumatic Dental InjuriesNCT05666180

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

An observational study of Traumatic Dental Injuries, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 24 to 71 months
Conditions the study is for
Traumatic Dental Injuries
How many people
192 participants
Where
No sites listed yet
Study dates
1 Feb 2023to 1 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 71 months
  • All sexes
  • Child

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Sara Abd Elraheem Abd Elmonem, bachelor contact

01148149772

sara.abdelreheem@dentistry.cu.edu.eg

About this study

Official title: 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.

Read the 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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

    Measured: 12 months

Secondary outcomes (1)
  1. Number of affected teeth in dentally traumatized preschool children

    By clinical examination

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2022
  2. Study start1 Feb 2023 (estimated)
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05666180
Sponsor's protocol ID
TDI
Status last verified
Dec 2022
First submitted
18 Dec 2022
Last updated
27 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32934871
  • 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.

    PubMed 17263880
  • 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.

    PubMed 8738905

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Dental Injuries, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sara Abd Elraheem Abd Elmonem, bachelor (01148149772, sara.abdelreheem@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05666180, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.

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