Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
52 participants
INTERVENTIONAL
2020-02-01
2022-11-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Success Rate of Prefabricated Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars
NCT06558812
Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers
NCT06573463
Clinical Evaluation of Bonded Versus Banded Space Maintainers
NCT05087147
Effects of Fixed and Removable Space Maintainers on Periodontal Health and DMFT/Dft Values
NCT03608345
Measuring Rate of Anteriors Retraction With Two Different Techniques
NCT05542745
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group I (B&L)
13 Band and loop (B\&L) appliance were included in group one
Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Group II (Ssb&l)
13 Single-sided Band and loop (SsB\&L) appliance were included in group two
Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Group III (DBW)
13 Direct Bonded Wire (DBW) appliance were included in group three
Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Group IV(T&L)
13 Tube and Loop (T\&L) appliance were included in group four
Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Extraction of the first primary molar was not exceeding three months.
3. Angle's class 1 occlusion with normal deciduous molar relation
4. Child not complaining from any systemic disease.
5. The extraction space was of only one missing first deciduous molar with remaining teeth present on mesial and distal side of extraction space.
6. Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite.
7. 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.
8. Radiographically, presence of permanent successor.
9. Absence of any pathological evidence on the eruption track of the permanent tooth.
10. Ability to attend follow-up appointments as required.
Exclusion Criteria
2. Prescence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite
3. Extraction of the first primary molar was exceeding three months.
4. The extraction space resulted from more than one missing deciduous molar
5. Radiographically, absence of permanent successor.
4 Years
8 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mansoura University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ibrahem H Elkalla, Professor
Role: STUDY_DIRECTOR
Department of Pediatric Dentistry Department, Mansoura University, Mansoura, Egypt
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Pediatric Dentistry, Mansoura University
Al Mansurah, Dakahleya Governorate, Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Gulec 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.
Setia 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.
Srivastava 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A27080120
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.