Premature Tooth ExfoliationNCT06558812
Evaluation of the Success Rate of Prefabricated Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars
A study testing prefabricated space maintainer and conventional space maintainer in people with Premature Tooth Exfoliation, run by Cairo University.
Trial summary
To assess the clinical efficacy of prefabricated space maintainers compared to conventional ones, focusing on preserving the integrity of each component of bands and loops, avoidance of soft tissue impingement as well as preservation of arch dimensions. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Tooth Exfoliation
- What is being tested?
- prefabricated space maintainer and conventional space maintainer
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to Oct 2025
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical criteria Medically free children.
- Patient and parent showing cooperation and compliance.
- Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.
- Freshly extracted single molars unilaterally or bilaterally
- Unilateral or bilateral loss of primary molars before or after the eruption of the first permanent molar
- Caries free or restored the mandibular second primary molars and deciduous canines in the side of the extraction maintained throughout the entire follow-up period.
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- Radiographic criteria
- Presence of succedaneous tooth bud.
- Presence of at least 1 mm bone overlying the succedaneous tooth germ
- 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.
- 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.
Dr.Sherif Bahgat El Tawil El Tawil, professor contact
About this study
Official title: Evaluation of the Success Rate of Prefabricated Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars A Randomized Clinical Trial
To assess the clinical efficacy of prefabricated space maintainers compared to conventional ones, focusing on preserving the integrity of each component of bands and loops, avoidance of soft tissue impingement as well as preservation of arch dimensions.
Read the detailed description
Management of the developing occlusion lies firmly within the scope of pediatric dentistry, therefore protection of dental arch integrity and inter-arch relations in the premature loss of teeth can be guaranteed by placing space maintainers. Conventional appliances are used successfully as space maintainers, although they have some disadvantages.The need for at least two visits to delivery, therefore cannot be planned in patients under general anesthesia. Fabrication of conventional and loop requires an alginate impression and laboratory work.
Prefabricated band and loop devices have been introduced to dentistry in recent times. They can possibly overcome most of the previously mentioned limitations of conventional space maintainers. The prefabricated band and loop space maintainer is adjusted and applied in one visit and therefore can be planned in patients under general anesthesia. Other advantages include less time, more patient and parent satisfaction, and no laboratory work
- Conditions
- Premature Tooth Exfoliation
- Being tested
- prefabricated space maintainer, conventional space maintainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prefabricated space maintainerDevice
Also called chair side space maintainer
- Prefabricated band will be selected for the abutment tooth by measuring the mesiodistal diameter of the abutment tooth with a caliper and will be adjusted with the internal diameter of the prefabricated band. ii. The loop will be selected based on the available mesiodistal space and buccolingual width of the abutment tooth, excessive length with be cut by cutting plier and will then place inside the band's tube by using a HOWE pliers. iii. Cotton roll isolation will use, then will be cemented with glass ionomer,
conventional space maintainerDevice
- A full arch Impressions will be taken with alginate material. ii. Impressions will be poured up using dental stone within 30 min of the impression taking. iii. The children will be given an appointment for space maintainer insertion. iv. In the second visit , Cotton roll isolation will use, cementation will be performed with glass ionomer .
| Study group | Role | What they receive |
|---|---|---|
| conventional space maintainer | Other | Conventional band and loops have been widely used with a high rate of success as the most practical way of space maintenance, as reported in numerous articles . Band and loop space maintainer is used to maintain space for successors of early lost primary molars. This is due to the ease and practicality of fabrication, adjustments and repairs of this space maintainer, as well as its ability to continue to function until the eruption of the permanent successor without interfering with their eruption The need for at least two visits to delivery, therefore cannot be planned in patients under general anesthesia. Fabrication of conventional and loop requires an alginate impression and laboratory work. Receives: Device: conventional space maintainer |
| prefabricated space maintainer | Other | Prefabricated band and loop devices have been introduced to dentistry in recent times. They can possibly overcome most of the previously mentioned limitations of conventional space maintainers. The prefabricated band and loop space maintainer is adjusted and applied in one visit and therefore can be planned in patients under general anesthesia. Other advantages include less time, more patient and parent satisfaction, and no laboratory work Receives: Device: prefabricated space maintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
appliance success
evaluation of clinical success criteria ( • Integrity of each component of band and loop - solder breakdown - decementation - abutment fracture - Soft tissue impingement ) Clinical examination by operator ( binary yes or no )
Measured: 0-3-9 month
Secondary outcomes (4)
Space loss between the abutment teeth.
- Change in distance measured on digital cast between the mesial midpoint of the second deciduous molar and the distal midpoint of the primary canine in mm
Measured: 0-9 month
arch dimension
measured each of
- Arch perimeter by measured on a digital cast as a sum of the incisor, canine and molar segment width in mm
- Inter canine width = Measured on a digital cast from cusp tip of canine on one side to cusp tip of canine on the other side in mm
- Intermolar width = Measured on a digital cast from central fossa of the second primary molar on one side to central fossa of the second primary molar on the other side in mm
Measured: 0-9 month
• Patient satisfaction
Patient-reported using 5-point Likert-type scale from 1-5 face scale
Measured: during insertion of appliance
• Cost effectiveness
Manually by incremental effectiveness cost ratio ,measuring unit is financial units per result
Measured: through study completion , an average of 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Dec 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature Tooth ExfoliationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled clinical trial, parallel group, allocation ratio 1:1 Framework superiority
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, amal fathy mahmoud mohammed elsayed saker, Cairo University
- Investigators
- Dina Yousry El Kharadly, Lecturer, Study director, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558812
- Sponsor's protocol ID
- Prefabricated space maintainer
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tahririan D, Safaripour M, Eshghi A, Bonyadian AH. Comparison of the longevity of prefabricated and conventional band and loops in children's primary teeth. Dent Res J (Isfahan). 2019 Nov 12;16(6):428-434. eCollection 2019 Nov-Dec.
PubMed 31803390Tyagi M, Rana V, Srivastava N, Kaushik N, Moirangthem E, Gaur V. Comparison of the Conventional Band and Loop Space Maintainers with Modified Space Maintainers: A Split-mouth Randomized Clinical Trial. Int J Clin Pediatr Dent. 2021;14(Suppl 1):S63-S68. doi: 10.5005/jp-journals-10005-2046.
PubMed 35082470
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Success Rate of Prefabricated Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06558812
- Acronym / sponsor ID
- Prefabricated space maintainer
- Conditions
- Premature Tooth Exfoliation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Aug 2024 (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.
To assess the clinical efficacy of prefabricated space maintainers compared to conventional ones, focusing on preserving the integrity of each component of bands and loops, avoidance of soft tissue impingement as well as preservation of arch dimensions.
Detailed description
Management of the developing occlusion lies firmly within the scope of pediatric dentistry, therefore protection of dental arch integrity and inter-arch relations in the premature loss of teeth can be guaranteed by placing space maintainers. Conventional appliances are used successfully as space maintainers, although they have some disadvantages.The need for at least two visits to delivery, therefore cannot be planned in patients under general anesthesia. Fabrication of conventional and loop requires an alginate impression and laboratory work.
Prefabricated band and loop devices have been introduced to dentistry in recent times. They can possibly overcome most of the previously mentioned limitations of conventional space maintainers. The prefabricated band and loop space maintainer is adjusted and applied in one visit and therefore can be planned in patients under general anesthesia. Other advantages include less time, more patient and parent satisfaction, and no laboratory work
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled clinical trial, parallel group, allocation ratio 1:1 Framework superiority
| Arm | Type | Receives |
|---|---|---|
| conventional space maintainer | Other | Device: conventional space maintainerConventional band and loops have been widely used with a high rate of success as the most practical way of space maintenance, as reported in numerous articles . Band and loop space maintainer is used to maintain space for successors of early lost primary molars. This is due to the ease and practicality of fabrication, adjustments and repairs of this space maintainer, as well as its ability to continue to function until the eruption of the permanent successor without interfering with their eruption The need for at least two visits to delivery, therefore cannot be planned in patients under general anesthesia. Fabrication of conventional and loop requires an alginate impression and laboratory work. |
| prefabricated space maintainer | Other | Device: prefabricated space maintainerPrefabricated band and loop devices have been introduced to dentistry in recent times. They can possibly overcome most of the previously mentioned limitations of conventional space maintainers. The prefabricated band and loop space maintainer is adjusted and applied in one visit and therefore can be planned in patients under general anesthesia. Other advantages include less time, more patient and parent satisfaction, and no laboratory work |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Clinical criteria Medically free children.
- Radiographic criteria
- Presence of succedaneous tooth bud.
- Presence of at least 1 mm bone overlying the succedaneous tooth germ
- 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 (3 listed)
- • Children with any parafunctional habits.
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 |
|---|---|---|
| prefabricated space maintainerAlso: chair side space maintaineri. Prefabricated band will be selected for the abutment tooth by measuring the mesiodistal diameter of the abutment tooth with a caliper and will be adjusted with the internal diameter of the prefabricated band. ii. The loop will be selected based on the available mesiodistal space and buccolingual width of the abutment tooth, excessive length with be cut by cutting plier and will then place inside the band's tube by using a HOWE pliers. iii. Cotton roll isolation will use, then will be cemented with glass ionomer, | Device | prefabricated space maintainer |
| conventional space maintaineri. A full arch Impressions will be taken with alginate material. ii. Impressions will be poured up using dental stone within 30 min of the impression taking. iii. The children will be given an appointment for space maintainer insertion. iv. In the second visit , Cotton roll isolation will use, cementation will be performed with glass ionomer . | Device | conventional space maintainer |
Primary outcome
appliance success
Time frame: 0-3-9 month
evaluation of clinical success criteria ( • Integrity of each component of band and loop - solder breakdown - decementation - abutment fracture - Soft tissue impingement ) Clinical examination by operator ( binary yes or no )
4 secondary outcomes
Space loss between the abutment teeth.
Time frame: 0-9 month
arch dimension
Time frame: 0-9 month
• Patient satisfaction
Time frame: during insertion of appliance
• Cost effectiveness
Time frame: through study completion , an average of 9 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Background: PubMed 31803390Tahririan D, Safaripour M, Eshghi A, Bonyadian AH. Comparison of the longevity of prefabricated and conventional band and loops in children's primary teeth. Dent Res J (Isfahan). 2019 Nov 12;16(6):428-434. eCollection 2019 Nov-Dec.
- Background: PubMed 35082470Tyagi M, Rana V, Srivastava N, Kaushik N, Moirangthem E, Gaur V. Comparison of the Conventional Band and Loop Space Maintainers with Modified Space Maintainers: A Split-mouth Randomized Clinical Trial. Int J Clin Pediatr Dent. 2021;14(Suppl 1):S63-S68. doi: 10.5005/jp-journals-10005-2046.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Premature Tooth Exfoliation
Active, not recruiting
Comparative Evaluation of Pediatric Patient Comfort, Time, and Preference Between Digital Scans and Rubber Base Impressions. Crossover Study Randomized Controlled Trial
Pediatric Patient With Early Loss of Primary Teeth
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.
Dr.Sherif Bahgat El Tawil El Tawil, professor contact
Dina Yousry El Kharadly, Lecturer study director
October 6 University
Questions about this trial
What is this clinical trial studying?
A study testing prefabricated space maintainer and conventional space maintainer in people with Premature Tooth Exfoliation, 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 10 inclusion and 3 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 19 Aug 2024. 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 amal fathi mahmoud sakr sakr (02001060718817, amal.fathy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
appliance success (time frame: 0-3-9 month). 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 NCT06558812, which also lists 2 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 19 Aug 2024.