PreTerm BirthNCT02999061
Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition
An observational study of PreTerm Birth, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- PreTerm Birth
- How many people
- 383 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2016to Jun 2017
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: population is limited to preterm birth children aged 2-5 years with primary teeth only , both genders are included.
Who may be able to join
- Children aged 2-5 years old.
- Presence of primary teeth only.
- Children born preterm at gestational age of 6,7 and 8 month.
Who cannot join
- Children with disability or mental disorders.
- Children with immune compromising conditions.
- Hospitalized and chronically ill children.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University Children's Hospital "Abo El-Rish" at El-Monira
Cairo Governorate
About this study
Official title: Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition: Across Sectional Study
The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.
Read the detailed description
The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.
PICO format:- Population (P) = preterm children aged 2-5 years attending Cairo University Children's Hospital "Abo El-Rish" at El-Monira, Cairo, Egypt.
Outcome (O) =prevalence of dental caries
- Conditions
- PreTerm Birth
- Keywords
- pre-term children
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dental caries.
measured by counting the number of participants affected by dental caries/total number of study sample X100 , measurement unit is a percentage (%)
Measured: 12 month
Secondary outcomes (2)
Assessment of oral hygiene .
using a Questionnaire (binary' yes or no questions'):-
- record child brushing habits(once or twice)
- consumption of fluoridated water (yes/no).
- visits to dentists (yes/no)
- Also using a dental mirror and a probe to detect presence of plaque (plaque index) and presence of caries (dmf score).
Measured: 12 month
Assessment of dietary habits
questionnaire (binary "yes/no questions")about the past and current feeding habits:-
- initial feeding of the child (breast or bottle answered yes/no)
- length of the breast feeding ( normal '0-2 years" or prolonged ">2years")
- usage of bottle after weaning (yes/no). number of meals per day (one,two or three, answered in yes/no manner)
- number of snacks per day (one,two or three in yes/no answers).
- Also using a dental mirror and a probe to detect caries presence (dmf score), higher scores indicates faulty dietary habits.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PreTerm BirthStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ohoud Tawfig ZainElabdeen, Cairo University
- Investigators
- Eman S Elmasry, Professor, Study director, Cairo UniversitySamah M Awad, Ass.Prof., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999061
- Sponsor's protocol ID
- CEBC-CU-2016-12-169
- Status last verified
- Jul 2017
- First submitted
- 15 Dec 2016
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brogardh-Roth S, Stjernqvist K, Matsson L. Dental behavioural management problems and dental caries prevalence in 3- to 6-year-old Swedish children born preterm. Int J Paediatr Dent. 2008 Sep;18(5):341-7. doi: 10.1111/j.1365-263x.2007.00884.x.
PubMed 18802992Cruvinel VR, Gravina DB, Azevedo TD, Bezerra AC, Toledo OA. Prevalence of dental caries and caries-related risk factors in premature and term children. Braz Oral Res. 2010 Jul-Sep;24(3):329-35. doi: 10.1590/s1806-83242010000300012.
PubMed 20877971Davenport ES, Litenas C, Barbayiannis P, Williams CE. The effects of diet, breast-feeding and weaning on caries risk for pre-term and low birth weight children. Int J Paediatr Dent. 2004 Jul;14(4):251-9. doi: 10.1111/j.1365-263X.2004.00557.x.
PubMed 15242381Seow WK, Lam JH, Tsang AK, Holcombe T, Bird PS. Oral Streptococcus species in pre-term and full-term children - a longitudinal study. Int J Paediatr Dent. 2009 Nov;19(6):406-11. doi: 10.1111/j.1365-263X.2009.01003.x. Epub 2009 Sep 1.
PubMed 19732193Lai PY, Seow WK, Tudehope DI, Rogers Y. Enamel hypoplasia and dental caries in very-low birthweight children: a case-controlled, longitudinal study. Pediatr Dent. 1997 Jan-Feb;19(1):42-9.
PubMed 9048413Rajshekar SA, Laxminarayan N. Comparison of primary dentition caries experience in pre-term low birth-weight and full-term normal birth-weight children aged one to six years. J Indian Soc Pedod Prev Dent. 2011 Apr-Jun;29(2):128-34. doi: 10.4103/0970-4388.84685.
PubMed 21911951Saraiva MC, Bettiol H, Barbieri MA, Silva AA. Are intrauterine growth restriction and preterm birth associated with dental caries? Community Dent Oral Epidemiol. 2007 Oct;35(5):364-76. doi: 10.1111/j.1600-0528.2006.00345.x.
PubMed 17822485Tanaka K, Miyake Y. Low birth weight, preterm birth or small-for-gestational-age are not associated with dental caries in young Japanese children. BMC Oral Health. 2014 Apr 14;14:38. doi: 10.1186/1472-6831-14-38.
PubMed 24731399
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition: Across Sectional Study
- ClinicalTrials.gov ID
- NCT02999061
- Acronym / sponsor ID
- CEBC-CU-2016-12-169
- Conditions
- PreTerm Birth
- Keywords
- pre-term children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Dec 2016 (estimated)
- 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.
The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.
Detailed description
The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.
PICO format:- Population (P) = preterm children aged 2-5 years attending Cairo University Children's Hospital "Abo El-Rish" at El-Monira, Cairo, Egypt.
Outcome (O) =prevalence of dental caries
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- population is limited to preterm birth children aged 2-5 years with primary teeth only , both genders are included.
Key inclusion criteria (3 listed)
- Children aged 2-5 years old.
- Presence of primary teeth only.
- Children born preterm at gestational age of 6,7 and 8 month.
Key exclusion criteria (3 listed)
- Children with disability or mental disorders.
- Children with immune compromising conditions.
- Hospitalized and chronically ill children.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of dental caries.
Time frame: 12 month
measured by counting the number of participants affected by dental caries/total number of study sample X100 , measurement unit is a percentage (%)
2 secondary outcomes
Assessment of oral hygiene .
Time frame: 12 month
Assessment of dietary habits
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Background: PubMed 18802992Brogardh-Roth S, Stjernqvist K, Matsson L. Dental behavioural management problems and dental caries prevalence in 3- to 6-year-old Swedish children born preterm. Int J Paediatr Dent. 2008 Sep;18(5):341-7. doi: 10.1111/j.1365-263x.2007.00884.x.
- Background: PubMed 20877971Cruvinel VR, Gravina DB, Azevedo TD, Bezerra AC, Toledo OA. Prevalence of dental caries and caries-related risk factors in premature and term children. Braz Oral Res. 2010 Jul-Sep;24(3):329-35. doi: 10.1590/s1806-83242010000300012.
- Background: PubMed 15242381Davenport ES, Litenas C, Barbayiannis P, Williams CE. The effects of diet, breast-feeding and weaning on caries risk for pre-term and low birth weight children. Int J Paediatr Dent. 2004 Jul;14(4):251-9. doi: 10.1111/j.1365-263X.2004.00557.x.
- Background: PubMed 19732193Seow WK, Lam JH, Tsang AK, Holcombe T, Bird PS. Oral Streptococcus species in pre-term and full-term children - a longitudinal study. Int J Paediatr Dent. 2009 Nov;19(6):406-11. doi: 10.1111/j.1365-263X.2009.01003.x. Epub 2009 Sep 1.
- Background: PubMed 9048413Lai PY, Seow WK, Tudehope DI, Rogers Y. Enamel hypoplasia and dental caries in very-low birthweight children: a case-controlled, longitudinal study. Pediatr Dent. 1997 Jan-Feb;19(1):42-9.
- Background: PubMed 21911951Rajshekar SA, Laxminarayan N. Comparison of primary dentition caries experience in pre-term low birth-weight and full-term normal birth-weight children aged one to six years. J Indian Soc Pedod Prev Dent. 2011 Apr-Jun;29(2):128-34. doi: 10.4103/0970-4388.84685.
- Background: PubMed 17822485Saraiva MC, Bettiol H, Barbieri MA, Silva AA. Are intrauterine growth restriction and preterm birth associated with dental caries? Community Dent Oral Epidemiol. 2007 Oct;35(5):364-76. doi: 10.1111/j.1600-0528.2006.00345.x.
- Background: PubMed 24731399Tanaka K, Miyake Y. Low birth weight, preterm birth or small-for-gestational-age are not associated with dental caries in young Japanese children. BMC Oral Health. 2014 Apr 14;14:38. doi: 10.1186/1472-6831-14-38.
- Individual participant dataSharing planned: No
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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.
Eman S Elmasry, Professor study director
Cairo University
Samah M Awad, Ass.Prof. study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PreTerm Birth, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of dental caries. (time frame: 12 month). 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 NCT02999061, which also lists 8 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 25 Jul 2017.