Tooth LossNCT03027765
Prevalence of Constructed Space Maintainers in a Group of Egyptian Children
An observational study of Tooth Loss, run by Cairo University.
Trial summary
The purpose of the study is To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University. Read more about this study
- Who is it for?
- Ages 2 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2017to 1 Aug 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Egyptian children with constructed space maintainers and their guardians attending Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University Both gender are included and Pediatric dentists at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
Who may be able to join
- All patients with constructed space maintainers
- Positive patient's acceptance for participation in the study.
- Both genders are included.
- Children Medically free from any systemic disease.
- -All Pediatric dentists having master degree and above.
Who cannot join
- Patients with orthodontic appliances.
- Patient having one of the different following habit thumb sucking, lip biting, tongue thrusting etc.
- 2nd population is pediatric dentists:
- -Pediatric dentists refused to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence of Constructed Space Maintainers in a Group of Egyptian Children Attending Pediatric Dentistry Department, Faculty of Oral and Dental Medicine Cairo University. A Cross-Sectional Study
The purpose of the study is
- To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
- To assess the knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University. and
- To assess the knowledge, attitude and practice of pediatric dentists towards use of space maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
Read the detailed description
The purpose of the study is
- To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
- To assess the knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University. and
- To assess the knowledge, attitude and practice of pediatric dentists towards use of space maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
PO1:
Population:
Egyptian children with constructed space maintainers and their guardians attending Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
Outcome1:
Prevalence of constructed space maintainers Knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians.
PO2
Population2:
Pediatric dentists at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
Outcome2:
knowledge, attitude and practice of pediatric dentists towards the use of the space maintainers.
- Conditions
- Tooth Loss
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Egyptian children | Population1: Egyptian children with constructed space maintainers at Cairo University. | |
| Pediatric dentists | Population2: Pediatric dentists at Cairo University. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of constructed space maintainers
Device for measurement through Visual examination and unit is Binary (Yes, No) and MCQ
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start1 Feb 2017 (estimated)
- Primary completion1 Aug 2017 (estimated)
- Study completion1 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Tooth LossStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Abdelwahab AbdelHameed, Cairo University
- Investigators
- Sherine Ezz Eldin Taha, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027765
- Sponsor's protocol ID
- Space Maintainers
- Status last verified
- Jan 2017
- First submitted
- 18 Jan 2017
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ari T. Follow-up problems with fixed appliances in pediatric dentistry. N Y State Dent J. 2015 Mar;81(2):16-20.
PubMed 25928968Asiry MA. Occlusal Status among 12-16 Year-Old School Children in Riyadh, Saudi Arabia. J Int Oral Health. 2015 May;7(5):20-3.
PubMed 26028897Baroni C, Franchini A, Rimondini L. Survival of different types of space maintainers. Pediatr Dent. 1994 Sep-Oct;16(5):360-1. No abstract available.
PubMed 7831141Brothwell DJ. Guidelines on the use of space maintainers following premature loss of primary teeth. J Can Dent Assoc. 1997 Nov;63(10):753, 757-60, 764-6.
PubMed 9401297Dhar V, Jain A, Van Dyke TE, Kohli A. Prevalence of gingival diseases, malocclusion and fluorosis in school-going children of rural areas in Udaipur district. J Indian Soc Pedod Prev Dent. 2007 Apr-Jun;25(2):103-5. doi: 10.4103/0970-4388.33458.
PubMed 17660647Dogan MC, Dogan SK, Kendi E. Complications of pediatric denture misuse: a case report. Oral Health Prev Dent. 2005;3(2):127-30.
PubMed 16173390Green J. Mind the gap: Overview of space maintaining appliances. Dent Nurs 2015; 11(1):24-7.
Kapala JT. Interceptive orthodontics and management of space problems. In: Braham RL, Morris ME. Textbook of Pediatric Dentistry, Eds. Baltimore, London, William & Wilkins Co. 1980: pp 320-356.
Keski-Nisula K, Hernesniemi R, Heiskanen M, Keski-Nisula L, Varrela J. Orthodontic intervention in the early mixed dentition: a prospective, controlled study on the effects of the eruption guidance appliance. Am J Orthod Dentofacial Orthop. 2008 Feb;133(2):254-60; quiz 328.e2. doi: 10.1016/j.ajodo.2006.05.039.
PubMed 18249292Laing E, Ashley P, Naini FB, Gill DS. Space maintenance. Int J Paediatr Dent. 2009 May;19(3):155-62. doi: 10.1111/j.1365-263X.2008.00951.x.
PubMed 19385999Leite-Cavalcanti A,de Alencar, Benzerra PK,Garcia A., Prevalence of early loss of primary molars in school children in Brazil. Pak Oral Dent J 2008; 28:113-6.
Petrunov V. Epidemiological research of malocclusions and the need of orthodontic treatment among the Bulgarians in the mixed to permanent dentition period, Disertation, Sofia 2012, p.62
Qudeimat MA, Fayle SA. The use of space maintainers at a UK pediatric dentistry department. ASDC J Dent Child. 1999 Nov-Dec;66(6):383-6.
PubMed 10656119Ronnerman A, Thilander B. A longitudinal study on the effect of unilateral extraction of primary molars. Scand J Dent Res. 1977 Jul;85(5):362-72. doi: 10.1111/j.1600-0722.1977.tb01516.x.
PubMed 268677Ronnerman A, Thilander B. Facial and dental arch morphology in children with and without early loss of deciduous molars. Am J Orthod. 1978 Jan;73(1):47-58. doi: 10.1016/0002-9416(78)90101-x. No abstract available.
PubMed 271472
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Constructed Space Maintainers in a Group of Egyptian Children Attending Pediatric Dentistry Department, Faculty of Oral and Dental Medicine Cairo University. A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT03027765
- Acronym / sponsor ID
- Space Maintainers
- Conditions
- Tooth Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (estimated)
- Primary completion
- 1 Aug 2017 (estimated)
- Study completion
- 1 Aug 2017 (estimated)
- First posted
- 23 Jan 2017 (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 constructed space maintainers at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
- To assess the knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University. and
- To assess the knowledge, attitude and practice of pediatric dentists towards use of space maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
Detailed description
The purpose of the study is
- To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
- To assess the knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University. and
- To assess the knowledge, attitude and practice of pediatric dentists towards use of space maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
PO1:
Population:
Egyptian children with constructed space maintainers and their guardians attending Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
Outcome1:
Prevalence of constructed space maintainers Knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians.
PO2
Population2:
Pediatric dentists at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
Outcome2:
knowledge, attitude and practice of pediatric dentists towards the use of the space maintainers.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Egyptian children | – | –Population1: Egyptian children with constructed space maintainers at Cairo University. |
| Pediatric dentists | – | –Population2: Pediatric dentists at Cairo University. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Egyptian children with constructed space maintainers and their guardians attending Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University Both gender are included and Pediatric dentists at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
Key inclusion criteria (5 listed)
- All patients with constructed space maintainers
- Positive patient's acceptance for participation in the study.
- Both genders are included.
- Children Medically free from any systemic disease.
- -All Pediatric dentists having master degree and above.
Key exclusion criteria (4 listed)
- Patients with orthodontic appliances.
- Patient having one of the different following habit thumb sucking, lip biting, tongue thrusting etc.
- -Pediatric dentists refused to participate in the study.
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 constructed space maintainers
Time frame: 6 months
Device for measurement through Visual examination and unit is Binary (Yes, No) and MCQ
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Background: PubMed 25928968Ari T. Follow-up problems with fixed appliances in pediatric dentistry. N Y State Dent J. 2015 Mar;81(2):16-20.
- Background: PubMed 26028897Asiry MA. Occlusal Status among 12-16 Year-Old School Children in Riyadh, Saudi Arabia. J Int Oral Health. 2015 May;7(5):20-3.
- Background: PubMed 7831141Baroni C, Franchini A, Rimondini L. Survival of different types of space maintainers. Pediatr Dent. 1994 Sep-Oct;16(5):360-1. No abstract available.
- Background: PubMed 9401297Brothwell DJ. Guidelines on the use of space maintainers following premature loss of primary teeth. J Can Dent Assoc. 1997 Nov;63(10):753, 757-60, 764-6.
- Background: PubMed 17660647Dhar V, Jain A, Van Dyke TE, Kohli A. Prevalence of gingival diseases, malocclusion and fluorosis in school-going children of rural areas in Udaipur district. J Indian Soc Pedod Prev Dent. 2007 Apr-Jun;25(2):103-5. doi: 10.4103/0970-4388.33458.
- Background: PubMed 16173390Dogan MC, Dogan SK, Kendi E. Complications of pediatric denture misuse: a case report. Oral Health Prev Dent. 2005;3(2):127-30.
- BackgroundGreen J. Mind the gap: Overview of space maintaining appliances. Dent Nurs 2015; 11(1):24-7.
- BackgroundKapala JT. Interceptive orthodontics and management of space problems. In: Braham RL, Morris ME. Textbook of Pediatric Dentistry, Eds. Baltimore, London, William & Wilkins Co. 1980: pp 320-356.
- Background: PubMed 18249292Keski-Nisula K, Hernesniemi R, Heiskanen M, Keski-Nisula L, Varrela J. Orthodontic intervention in the early mixed dentition: a prospective, controlled study on the effects of the eruption guidance appliance. Am J Orthod Dentofacial Orthop. 2008 Feb;133(2):254-60; quiz 328.e2. doi: 10.1016/j.ajodo.2006.05.039.
- Background: PubMed 19385999Laing E, Ashley P, Naini FB, Gill DS. Space maintenance. Int J Paediatr Dent. 2009 May;19(3):155-62. doi: 10.1111/j.1365-263X.2008.00951.x.
- BackgroundLeite-Cavalcanti A,de Alencar, Benzerra PK,Garcia A., Prevalence of early loss of primary molars in school children in Brazil. Pak Oral Dent J 2008; 28:113-6.
- BackgroundPetrunov V. Epidemiological research of malocclusions and the need of orthodontic treatment among the Bulgarians in the mixed to permanent dentition period, Disertation, Sofia 2012, p.62
- 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.
Sherine Ezz Eldin Taha, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Loss, 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 5 inclusion and 4 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 24 Jan 2017. 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 Yara AbdulWahab AbdulHameed Moawad, bachelor (+201116108317, yaramoawad@rocketmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of constructed space maintainers (time frame: 6 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 NCT03027765, which also lists 16 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 24 Jan 2017.