NCT05666180

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

December 18, 2022

Last Update Submit

December 18, 2022

Conditions

Outcome Measures

Primary Outcomes (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

    12 months

Secondary Outcomes (1)

  • Number of affected teeth in dentally traumatized preschool children

    12 months

Eligibility Criteria

Age24 Months - 71 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 32934871BACKGROUND
  • 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.

    PMID: 17263880BACKGROUND
  • 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.

    PMID: 8738905BACKGROUND

Central Study Contacts

Sara Abd Elraheem Abd Elmonem, bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dentist

Study Record Dates

First Submitted

December 18, 2022

First Posted

December 27, 2022

Study Start

February 1, 2023

Primary Completion

February 1, 2024

Study Completion

March 1, 2024

Last Updated

December 27, 2022

Record last verified: 2022-12