NCT05304260

Brief Summary

To assess the prevalence of dental anomalies in the deciduous dentition in children with oral clefts and to investigate the associated risk factors.

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
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

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

February 12, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

February 12, 2022

Last Update Submit

March 22, 2022

Conditions

Anomaly

Keywords

dental anomalies

Outcome Measures

Primary Outcomes (1)

  • Prevalence of dental anomalies

    measurement method: clinical and radiographic examination used to asses prevalence of dental anomalies, unit of measurement binary (yes, no).

    baseline

Secondary Outcomes (1)

  • Predisposing risk factors for oral clefts

    baseline

Interventions

clinical and radiographic examinationOTHER

Prevalence of dental anomalies in deciduous dentition and risk factors associated with non-syndromic oral clefts patients: A cross-sectional study.

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

oral clefts children

You may qualify if:

  • Children with oral cleft lip and/or palate with ages varying from 4 to 6 years.
  • Children with primary dentition.
  • Parents who accept to participate in the study.
  • Compliant children.

You may not qualify if:

  • Healthy children and their guardians
  • Syndromic oral clefts children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 1. Carolina, A., Cordeiro, S., Isabel, ;, Olegário Da Costa, C., Carmela, ;, Bresolin, R., Carlos, J., & Imparato, P. (2018). Calidad de vida relacionada con la salud oral, características socioeconómicas y de comportamiento de los pacientes fisurados menores de 7 años Artículo Original (Vol. 8, Issue 1).

    BACKGROUND

  • Qi L, Liu J, Zhang Y, Wang J, Yang M, Gong T, Shen M, Du Y. Risk factors for non-syndromic oral clefts: a matched case-control study in Hubei Province, China. Oral Dis. 2015 Jan;21(1):31-7. doi: 10.1111/odi.12200. Epub 2013 Nov 19.

    PMID: 24147616BACKGROUND

  • Shilpa G, Gokhale N, Mallineni SK, Nuvvula S. Prevalence of dental anomalies in deciduous dentition and its association with succedaneous dentition: A cross-sectional study of 4180 South Indian children. J Indian Soc Pedod Prev Dent. 2017 Jan-Mar;35(1):56-62. doi: 10.4103/0970-4388.199228.

    PMID: 28139484BACKGROUND

  • 4. Tamburini, A. B. F., Rodrigues, Y. H. P., Martelli, D. R. B., de Barros, L. M., de Andrade, R. S., Machado, R. A., Coletta, R. della, Martelli-Júnior, H., & Flório, F. M. (2020). Dental anomalies in the deciduous dentition of non-syndromic oral clefts patients. Revista Brasileira de Saude Materno Infantil, 20(1), 257-263. https://doi.org/10.1590/1806-93042020000100014

    BACKGROUND

  • Tannure PN, Oliveira CA, Maia LC, Vieira AR, Granjeiro JM, Costa Mde C. Prevalence of dental anomalies in nonsyndromic individuals with cleft lip and palate: a systematic review and meta-analysis. Cleft Palate Craniofac J. 2012 Mar;49(2):194-200. doi: 10.1597/10-043. Epub 2011 Jul 8.

    PMID: 21740173BACKGROUND

MeSH Terms

Conditions

Congenital AbnormalitiesTooth Abnormalities

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Central Study Contacts

Saada Mohammed

CONTACT

01121562456saadaibrahim@dentistry.cu.edu.eg

Soad Abdel Moneim

CONTACT

01005654355

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 12, 2022

First Posted

March 31, 2022

Study Start

January 1, 2023

Primary Completion

April 30, 2023

Study Completion

May 31, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03