AnomalyNCT05304260
Prevalence of Dental Anomalies in Oral Clefts Patients
An observational study of Anomaly, run by Cairo University.
Trial summary
To assess the prevalence of dental anomalies in the deciduous dentition in children with oral clefts and to investigate the associated risk factors. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Anomaly
- What is being tested?
- clinical and radiographic examination
- Type of treatment
- Pill or oral medicine
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 May 2023
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: oral clefts children
Who may be able to join
- 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.
Who cannot join
- Healthy children and their guardians
- Syndromic oral clefts children
Trial locations and contacts
No sites are listed yet.
Soad Abdel Moneim contact
About this study
Official title: Prevalence of Dental Anomalies in Deciduous Dentition and Risk Factors Associated With Non-syndromic Oral Clefts Patients: A Cross-sectional Study.
To assess the prevalence of dental anomalies in the deciduous dentition in children with oral clefts and to investigate the associated risk factors.
Read the detailed description
Oral clefts lip and/or palate are considered as the most common oro-facial defects in children with an unclear complex etiology.
The international prevalence in newborns was estimated as 14 per 10,000 live births worldwide. Around 70% of cases occur as a non-syndromic cleft lip and/or cleft palate (NSCL/P)], and the resting 30% are associated with Mendelian disorders or teratogenic, chromosomal and sporadic conditions.
Non syndromic cleft lip and/or palate divided into cleft lip (CL), cleft lip and palate (CL/P) and cleft palate (CP) based on epidemiological features and embryologic timing.
The exact etiology is not completely known, but attributed to a mixture of genetic and environmental factors. The usefulness of epidemiological knowledge is important in assessing the burden of oral clefts in order to plan public health resources. Also, knowing the causes of oral clefts, which stimulates research on primary prevention and treatments to improve the quality of health and care.
The incidence of dental defects in cleft patients can be used as clinical indicators for defining cleft sub-phenotypes, as well as providing numbers of instances.
Dental anomalies in children can lead to an increased risk of dental problems from esthetic to orthodontic problems. In Egypt, there is lacking of information on the occurrence of dental defects in the deciduous dentition of children with oral clefts. Also oral clefts are complicated epidemiological condition and further investigations are needed to know about the risk factors of this situation.
- Conditions
- Anomaly
- Being tested
- clinical and radiographic examination
- Keywords
- dental anomalies
- Medical subject headings
- Congenital Abnormalities, Tooth Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dental anomalies
measurement method: clinical and radiographic examination used to asses prevalence of dental anomalies, unit of measurement binary (yes, no).
Measured: baseline
Secondary outcomes (1)
Predisposing risk factors for oral clefts
Measurement method: questionnaire used to assess risk factors of oral clefts, measurement unit: binary questions (yes, no).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnomalyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saada Mohammed Ibrahim El-Aarag, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304260
- Sponsor's protocol ID
- prevalence of dental anomalies
- Status last verified
- Mar 2022
- First submitted
- 12 Feb 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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).
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.
PubMed 24147616Shilpa 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.
PubMed 281394844. 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
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.
PubMed 21740173
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Dental Anomalies in Deciduous Dentition and Risk Factors Associated With Non-syndromic Oral Clefts Patients: A Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT05304260
- Acronym / sponsor ID
- prevalence of dental anomalies
- Conditions
- Anomaly
- Keywords
- dental anomalies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the prevalence of dental anomalies in the deciduous dentition in children with oral clefts and to investigate the associated risk factors.
Detailed description
Oral clefts lip and/or palate are considered as the most common oro-facial defects in children with an unclear complex etiology.
The international prevalence in newborns was estimated as 14 per 10,000 live births worldwide. Around 70% of cases occur as a non-syndromic cleft lip and/or cleft palate (NSCL/P)], and the resting 30% are associated with Mendelian disorders or teratogenic, chromosomal and sporadic conditions.
Non syndromic cleft lip and/or palate divided into cleft lip (CL), cleft lip and palate (CL/P) and cleft palate (CP) based on epidemiological features and embryologic timing.
The exact etiology is not completely known, but attributed to a mixture of genetic and environmental factors. The usefulness of epidemiological knowledge is important in assessing the burden of oral clefts in order to plan public health resources. Also, knowing the causes of oral clefts, which stimulates research on primary prevention and treatments to improve the quality of health and care.
The incidence of dental defects in cleft patients can be used as clinical indicators for defining cleft sub-phenotypes, as well as providing numbers of instances.
Dental anomalies in children can lead to an increased risk of dental problems from esthetic to orthodontic problems. In Egypt, there is lacking of information on the occurrence of dental defects in the deciduous dentition of children with oral clefts. Also oral clefts are complicated epidemiological condition and further investigations are needed to know about the risk factors of this situation.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- oral clefts children
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Healthy children and their guardians
- Syndromic oral clefts children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical and radiographic examinationPrevalence of dental anomalies in deciduous dentition and risk factors associated with non-syndromic oral clefts patients: A cross-sectional study. | Other | – |
Primary outcome
Prevalence of dental anomalies
Time frame: baseline
measurement method: clinical and radiographic examination used to asses prevalence of dental anomalies, unit of measurement binary (yes, no).
1 secondary outcome
Predisposing risk factors for oral clefts
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background1. 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: PubMed 24147616Qi 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.
- Background: PubMed 28139484Shilpa 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.
- Background4. 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: PubMed 21740173Tannure 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soad Abdel Moneim contact
Questions about this trial
What is this clinical trial studying?
An observational study of Anomaly, 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 4 inclusion and 2 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 31 Mar 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 Saada Mohammed (01121562456, saadaibrahim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of dental anomalies (time frame: baseline). 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 NCT05304260, which also lists 5 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 31 Mar 2022.