Dental PlaqueNCT03608345
Effects of Fixed and Removable Space Maintainers on Periodontal Health and DMFT/Dft Values
An observational study of Dental Plaque, run by Altinbas University.
Trial summary
Space maintainers are appliances that applied when primary teeth were lost prematurely because of many reasons such as tooth decay, trauma, lack of germ of permanent tooth.4 Space problems play an important role in practice of dentistry and also understanding of the dental development in the primary and mixed… Read more about this study
- Who is it for?
- Ages 4 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- space maintainer
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 2014
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 100 patient whose age between a range of 4-15 years due to having early loss of teeth and were treated with fixed and removable space maintainers in Istanbul University Faculty of Dentistry Department of Pediatric Dentistry were included to this study.
Who may be able to join
- healthy and applied space maintainer patients
Who cannot join
- unhealthy and non-applied space maintainer patients
About this study
Official title: Effects of Space Maintainers on Oral Health
Space maintainers are appliances that applied when primary teeth were lost prematurely because of many reasons such as tooth decay, trauma, lack of germ of permanent tooth.4 Space problems play an important role in practice of dentistry and also understanding of the dental development in the primary and mixed dentitions could help to intercept the malocclusion.The aim of this study is to evaluate the effects of applied space maintainers on periodontal health and dental status after teeth missing in pediatric dentistry clinic.
Read the detailed description
The study was approved by the Ethics Committee of the Istanbul University Faculty of Dentistry (No:2014/8) and was carried out in agreement with the Declaration of Helsinki principles. This study conducted 104 patient whose age between the range of 4-15 years were chosen to applied fixed (band and loop, palatal arch, lingual arch) or removable space maintainers in Istanbul University Faculty of Dentistry Department of Pediatric Dentistry were followed between years of 2013-2014. Totally, four of the patients excluded due to systemically and genetically disorder.
In primary and mixed dentition, dft index was used and in permanent dentition DMFT index was used. Longevity time in the mouth, the number of developing new caries were evaluated and DMFT/dft and plaque index were compared.
- Conditions
- Dental Plaque
- Being tested
- space maintainer
- Keywords
- oral health, dental plaque, space maintenance
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
space maintainerOther
Space maintainers are applied after the missing teeth in pediatric dentistry for protection of size of extracted area.
What is being measured
The primary outcome is the main question the study is designed to answer.
DMFT/dft index value changes after applying space maintainers
With visual examination DMFT/dft index value changes were recorded to patient files
Measured: 12 months
Secondary outcomes (1)
Plaque index value changes after applying space maintainers
With visual examination and rounded explorer, plaque index value changes were recorded to patient files according to Sillness and Loe.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altinbas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliye Tugce Gurcan, Altinbas University
- Investigators
- Aliye Tuğçe Gürcan, Assist.Prof., Principal investigator, Altinbas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608345
- Sponsor's protocol ID
- Altinbas University
- Status last verified
- Jul 2018
- First submitted
- 2 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Arikan V, Kizilci E, Ozalp N, Ozcelik B. Effects of Fixed and Removable Space Maintainers on Plaque Accumulation, Periodontal Health, Candidal and Enterococcus Faecalis Carriage. Med Princ Pract. 2015;24(4):311-7. doi: 10.1159/000430787. Epub 2015 Jun 4.
PubMed 26044443American Academy on Pediatric Dentistry Clinical Affairs Committee-Developing Dentition Subcommittee; American Academy on Pediatric Dentistry Council on Clinical Affairs. Guideline on management of the developing dentition and occlusion in pediatric dentistry. Pediatr Dent. 2008-2009;30(7 Suppl):184-95. No abstract available.
PubMed 19216419Arikan F, Eronat N, Candan U, Boyacioglu H. Periodontal conditions associated with space maintainers following two different dental health education techniques. J Clin Pediatr Dent. 2007 Summer;31(4):229-34. doi: 10.17796/jcpd.31.4.9588m43n027t560n.
PubMed 19161056
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Space Maintainers on Oral Health
- ClinicalTrials.gov ID
- NCT03608345
- Acronym / sponsor ID
- Altinbas University
- Conditions
- Dental Plaque
- Keywords
- oral health, dental plaque, space maintenance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Altinbas UniversityUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 Jul 2018 (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.
Space maintainers are appliances that applied when primary teeth were lost prematurely because of many reasons such as tooth decay, trauma, lack of germ of permanent tooth.4 Space problems play an important role in practice of dentistry and also understanding of the dental development in the primary and mixed dentitions could help to intercept the malocclusion.The aim of this study is to evaluate the effects of applied space maintainers on periodontal health and dental status after teeth missing in pediatric dentistry clinic.
Detailed description
The study was approved by the Ethics Committee of the Istanbul University Faculty of Dentistry (No:2014/8) and was carried out in agreement with the Declaration of Helsinki principles. This study conducted 104 patient whose age between the range of 4-15 years were chosen to applied fixed (band and loop, palatal arch, lingual arch) or removable space maintainers in Istanbul University Faculty of Dentistry Department of Pediatric Dentistry were followed between years of 2013-2014. Totally, four of the patients excluded due to systemically and genetically disorder.
In primary and mixed dentition, dft index was used and in permanent dentition DMFT index was used. Longevity time in the mouth, the number of developing new caries were evaluated and DMFT/dft and plaque index were compared.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 100 patient whose age between a range of 4-15 years due to having early loss of teeth and were treated with fixed and removable space maintainers in Istanbul University Faculty of Dentistry Department of Pediatric Dentistry were included to this study.
Key inclusion criteria (1 listed)
- healthy and applied space maintainer patients
Key exclusion criteria (1 listed)
- unhealthy and non-applied space maintainer patients
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 |
|---|---|---|
| space maintainerSpace maintainers are applied after the missing teeth in pediatric dentistry for protection of size of extracted area. | Other | – |
Primary outcome
DMFT/dft index value changes after applying space maintainers
Time frame: 12 months
With visual examination DMFT/dft index value changes were recorded to patient files
1 secondary outcome
Plaque index value changes after applying space maintainers
Time frame: 12 months
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 31 Jul 2018.
- Background: PubMed 26044443Arikan V, Kizilci E, Ozalp N, Ozcelik B. Effects of Fixed and Removable Space Maintainers on Plaque Accumulation, Periodontal Health, Candidal and Enterococcus Faecalis Carriage. Med Princ Pract. 2015;24(4):311-7. doi: 10.1159/000430787. Epub 2015 Jun 4.
- Background: PubMed 19216419American Academy on Pediatric Dentistry Clinical Affairs Committee-Developing Dentition Subcommittee; American Academy on Pediatric Dentistry Council on Clinical Affairs. Guideline on management of the developing dentition and occlusion in pediatric dentistry. Pediatr Dent. 2008-2009;30(7 Suppl):184-95. No abstract available.
- Background: PubMed 19161056Arikan F, Eronat N, Candan U, Boyacioglu H. Periodontal conditions associated with space maintainers following two different dental health education techniques. J Clin Pediatr Dent. 2007 Summer;31(4):229-34. doi: 10.17796/jcpd.31.4.9588m43n027t560n.
- 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.
Aliye Tuğçe Gürcan, Assist.Prof. principal investigator
Altinbas University
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Plaque, run by Altinbas 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 1 inclusion and 1 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 31 Jul 2018. 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?
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?
DMFT/dft index value changes after applying space maintainers (time frame: 12 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 NCT03608345, which also lists 3 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 Jul 2018.