Early Tooth ExfoliationNCT05693870
Different Designs of Space Maintainer
A study testing Fixed space maintainer in people with Early Tooth Exfoliation, run by Mansoura University at 1 site in Egypt.
Trial summary
Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one. Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Early Tooth Exfoliation
- What is being tested?
- Fixed space maintainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 5 Nov 2022
- Phase
- Interventional
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and their parents showed cooperation and compliance.
- Extraction of the first primary molar was not exceeding three months.
- Angle's class 1 occlusion with normal deciduous molar relation
- Child not complaining from any systemic disease.
- The extraction space was of only one missing first deciduous molar with remaining teeth present on mesial and distal side of extraction space.
- Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite.
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- No restorative application on the buccal surfaces of abutment teeth, otherwise extra-coronal complete coverage, as stainless-steel crown, was applied only in banded groups.
- Radiographically, presence of permanent successor.
- Absence of any pathological evidence on the eruption track of the permanent tooth.
- Ability to attend follow-up appointments as required.
Who cannot join
- Child complaining from any systemic disease.
- Prescence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite
- Extraction of the first primary molar was exceeding three months.
- The extraction space resulted from more than one missing deciduous molar
- Radiographically, absence of permanent successor.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Pediatric Dentistry, Mansoura University
Al Mansurah, Dakahleya Governorate, 35511
About this study
Official title: Clinical Evaluation of Different Designs of Fixed Space Maintainer. A Randomized Clinical Trial
Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one.
Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). In Group I, Band and loop (B\&L), Group II: Single-sided band and loop (Ss B\&L), Group III: Direct bonded wire (DBW), Group IV: Tube and loop (T\&L). children were recalled at 3, 6, 9, 12,15-month.
Read the detailed description
Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one.
Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). In Group I, Band and loop (B\&L), Group II: Single-sided band and loop (Ss B\&L), Group III: Direct bonded wire (DBW), Group IV: Tube and loop (T\&L). children were recalled at 3, 6, 9, 12,15-month. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier method with log rank test. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier method with log rank test. Sample size: The total sample size was calculated using Sampsize application with anticipated success on treatment with conventional band and loop 86% , anticipated response on treatment with direct bonded wire 33% 12, at 80% power, and significant level 0.05.
- Conditions
- Early Tooth Exfoliation
- Being tested
- Fixed space maintainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed space maintainerDevice
Also called Bonded or/ Banded space maintainers
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
| Study group | Role | What they receive |
|---|---|---|
| Group I (B&L) | Experimental | 13 Band and loop (B\&L) appliance were included in group one Receives: Device: Fixed space maintainer |
| Group II (Ssb&l) | Experimental | 13 Single-sided Band and loop (SsB\&L) appliance were included in group two Receives: Device: Fixed space maintainer |
| Group III (DBW) | Experimental | 13 Direct Bonded Wire (DBW) appliance were included in group three Receives: Device: Fixed space maintainer |
| Group IV(T&L) | Experimental | 13 Tube and Loop (T\&L) appliance were included in group four Receives: Device: Fixed space maintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median survival rate
Cumulative survival rates of space maintainers were estimated by means of Kaplan-Meier method with log rank test
Measured: 15 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 2023
- Study start1 Feb 2020
- Primary completion3 Jan 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Early Tooth ExfoliationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ibrahem H Elkalla, Professor, Study director, Department of Pediatric Dentistry Department, Mansoura University, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693870
- Sponsor's protocol ID
- A27080120
- Status last verified
- Jan 2023
- First submitted
- 7 Jan 2023
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tunc ES, Bayrak S, Tuloglu N, Egilmez T, Isci D. Evaluation of survival of 3 different fixed space maintainers. Pediatr Dent. 2012 Jul-Aug;34(4):e97-102.
PubMed 23014081Gulec S, Dogan MC, Seydaoglu G. Clinical evaluation of a new bonded space maintainer. J Clin Orthod. 2014 Dec;48(12):784-90. No abstract available.
PubMed 25708113Setia V, Kumar Pandit I, Srivastava N, Gugnani N, Gupta M. Banded vs Bonded Space Maintainers: Finding Better Way Out. Int J Clin Pediatr Dent. 2014 May;7(2):97-104. doi: 10.5005/jp-journals-10005-1245. Epub 2014 Aug 29.
PubMed 25356008Srivastava N, Grover J, Panthri P. Space Maintenance with an Innovative "Tube and Loop" Space Maintainer (Nikhil Appliance). Int J Clin Pediatr Dent. 2016 Jan-Mar;9(1):86-9. doi: 10.5005/jp-journals-10005-1340. Epub 2016 Apr 22.
PubMed 27274163
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Different Designs of Fixed Space Maintainer. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05693870
- Acronym / sponsor ID
- A27080120
- Conditions
- Early Tooth Exfoliation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 23 Jan 2023 (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.
Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one.
Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). In Group I, Band and loop (B\&L), Group II: Single-sided band and loop (Ss B\&L), Group III: Direct bonded wire (DBW), Group IV: Tube and loop (T\&L). children were recalled at 3, 6, 9, 12,15-month.
Detailed description
Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one.
Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). In Group I, Band and loop (B\&L), Group II: Single-sided band and loop (Ss B\&L), Group III: Direct bonded wire (DBW), Group IV: Tube and loop (T\&L). children were recalled at 3, 6, 9, 12,15-month. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier method with log rank test. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier method with log rank test. Sample size: The total sample size was calculated using Sampsize application with anticipated success on treatment with conventional band and loop 86% , anticipated response on treatment with direct bonded wire 33% 12, at 80% power, and significant level 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (B&L) | Experimental | Device: Fixed space maintainer13 Band and loop (B\&L) appliance were included in group one |
| Group II (Ssb&l) | Experimental | Device: Fixed space maintainer13 Single-sided Band and loop (SsB\&L) appliance were included in group two |
| Group III (DBW) | Experimental | Device: Fixed space maintainer13 Direct Bonded Wire (DBW) appliance were included in group three |
| Group IV(T&L) | Experimental | Device: Fixed space maintainer13 Tube and Loop (T\&L) appliance were included in group four |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Children and their parents showed cooperation and compliance.
- Extraction of the first primary molar was not exceeding three months.
- Angle's class 1 occlusion with normal deciduous molar relation
- Child not complaining from any systemic disease.
- The extraction space was of only one missing first deciduous molar with remaining teeth present on mesial and distal side of extraction space.
Key exclusion criteria (5 listed)
- Child complaining from any systemic disease.
- Prescence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite
- Extraction of the first primary molar was exceeding three months.
- The extraction space resulted from more than one missing deciduous molar
- Radiographically, absence of permanent successor.
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 |
|---|---|---|
| Fixed space maintainerAlso: Bonded or/ Banded space maintainersAppliance bonded with composite resin or/banded and cemented with glass ionomer cement | Device | Group I (B&L), Group II (Ssb&l), Group III (DBW), Group IV(T&L) |
Primary outcome
Median survival rate
Time frame: 15 months
Cumulative survival rates of space maintainers were estimated by means of Kaplan-Meier method with log rank test
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 23 Jan 2023.
- Background: PubMed 23014081Tunc ES, Bayrak S, Tuloglu N, Egilmez T, Isci D. Evaluation of survival of 3 different fixed space maintainers. Pediatr Dent. 2012 Jul-Aug;34(4):e97-102.
- Background: PubMed 25708113Gulec S, Dogan MC, Seydaoglu G. Clinical evaluation of a new bonded space maintainer. J Clin Orthod. 2014 Dec;48(12):784-90. No abstract available.
- Results publication: PubMed 25356008Setia V, Kumar Pandit I, Srivastava N, Gugnani N, Gupta M. Banded vs Bonded Space Maintainers: Finding Better Way Out. Int J Clin Pediatr Dent. 2014 May;7(2):97-104. doi: 10.5005/jp-journals-10005-1245. Epub 2014 Aug 29.
- Results publication: PubMed 27274163Srivastava N, Grover J, Panthri P. Space Maintenance with an Innovative "Tube and Loop" Space Maintainer (Nikhil Appliance). Int J Clin Pediatr Dent. 2016 Jan-Mar;9(1):86-9. doi: 10.5005/jp-journals-10005-1340. Epub 2016 Apr 22.
- 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.
Ibrahem H Elkalla, Professor study director
Department of Pediatric Dentistry Department, Mansoura University, Mansoura, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed space maintainer in people with Early Tooth Exfoliation, run by Mansoura 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 10 inclusion and 5 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 23 Jan 2023. 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?
Median survival rate (time frame: 15 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 NCT05693870, which also lists 4 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 23 Jan 2023.