Tooth LossNCT05087147
Clinical Evaluation of Bonded Versus Banded Space Maintainers
A study testing 0.7 mm stainless steel orthodontic wire and Banded space maintainer in people with Tooth Loss, run by Omar Sherif Ahmed Abo El Abbas.
Trial summary
Comparing bonded space maintainers to banded space maintainers Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- 0.7 mm stainless steel orthodontic wire and Banded space maintainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Sep 2023
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient and parent showing cooperation and compliance. Medically free children. Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.
- Having all first permanent molars erupted and in Class I molar relation. According to space analysis available space is less than or equal to needed space.
- Having all their mandibular incisors erupted. With deciduous canines and second deciduous molars in the side of the extraction maintained throughout the entire follow-up period. Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines. 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars.
Who cannot join
- Children with any parafunctional habits. Children with previous allergies to stainless steel. Crowned abutment teeth. Permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of Bonded Versus Banded Space Maintainers in Children With Prematurely Lost First Primary Molars: A Randomized Controlled Clinical Trial
Comparing bonded space maintainers to banded space maintainers
Read the detailed description
Comparing bonded space maintainers to banded ones regarding clinical success in maintaining the space for the prematurely lost primary molar and radiographic space loss in both banded and bonded space maintainers. Finally, patient satisfaction regarding both treatments.
- Conditions
- Tooth Loss
- Being tested
- 0.7 mm stainless steel orthodontic wire, Banded space maintainer
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.7 mm stainless steel orthodontic wireDevice
0.7 mm stainless steel orthodontic wire
Banded space maintainerDevice
band and loop space maintainer
| Study group | Role | What they receive |
|---|---|---|
| Bonded space maintainer | Experimental | Wire bonded with composite to abutment teeth Receives: Device: 0.7 mm stainless steel orthodontic wire |
| Banded space maintainer | Active comparator | Band and loop space maintainer Receives: Device: Banded space maintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
appliance failure
Patient reported
Measured: up to 12 months
Secondary outcomes (1)
Radiographic space loss
in millimeters
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Jul 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omar Sherif Ahmed Abo El Abbas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Sherif Ahmed Abo El Abbas, Cairo University
- Investigators
- Omar S Abo El Abbas, Principal investigator, Cairo U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087147
- Sponsor's protocol ID
- space maintainer
- Status last verified
- May 2022
- First submitted
- 27 Sep 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Bonded Versus Banded Space Maintainers in Children With Prematurely Lost First Primary Molars: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05087147
- Acronym / sponsor ID
- space maintainer
- Conditions
- Tooth Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Omar Sherif Ahmed Abo El AbbasUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 21 Oct 2021 (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.
Comparing bonded space maintainers to banded space maintainers
Detailed description
Comparing bonded space maintainers to banded ones regarding clinical success in maintaining the space for the prematurely lost primary molar and radiographic space loss in both banded and bonded space maintainers. Finally, patient satisfaction regarding both treatments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bonded space maintainer | Experimental | Device: 0.7 mm stainless steel orthodontic wireWire bonded with composite to abutment teeth |
| Banded space maintainer | Active comparator | Device: Banded space maintainerBand and loop space maintainer |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient and parent showing cooperation and compliance. Medically free children. Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.
- Having all first permanent molars erupted and in Class I molar relation. According to space analysis available space is less than or equal to needed space.
- Having all their mandibular incisors erupted. With deciduous canines and second deciduous molars in the side of the extraction maintained throughout the entire follow-up period. Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines. 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars.
Key exclusion criteria (1 listed)
- Children with any parafunctional habits. Children with previous allergies to stainless steel. Crowned abutment teeth. Permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer.
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 |
|---|---|---|
| 0.7 mm stainless steel orthodontic wire0.7 mm stainless steel orthodontic wire | Device | Bonded space maintainer |
| Banded space maintainerband and loop space maintainer | Device | Banded space maintainer |
Primary outcome
appliance failure
Time frame: up to 12 months
Patient reported
1 secondary outcome
Radiographic space loss
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- 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.
Omar S Abo El Abbas principal investigator
Cairo U
Questions about this trial
What is this clinical trial studying?
A study testing 0.7 mm stainless steel orthodontic wire and Banded space maintainer in people with Tooth Loss, run by Omar Sherif Ahmed Abo El Abbas.
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 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: status not confirmed, as of the sponsor's last update on 17 May 2022. 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 Omar S Abo El Abbas (0225196520 ext. Manial, omar_aboelabbas0107@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
appliance failure (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2022.