Premature Tooth ExfoliationNCT06573463
Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers
A study testing Prefabricated band and loop and Conventional Band and loop in people with Premature Tooth Exfoliation, run by Cairo University at 1 site in Egypt.
Trial summary
To assess the longevity of prefabricated versus conventional band and loop space maintainers in children with prematurely lost first primary molars. A Randomized Clinical Trial 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 band and loop and Conventional Band and loop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- 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
- Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.
- Caries free, or restored mandibular second primary molars and deciduous canines on the side of the extraction maintained throughout the entire follow-up period.
- Children are classified as cooperative or potentially cooperative according to Wright's classification of child behavior.
- According to space analysis, available space is less than or equal to the needed space
- 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars
- Children are mentally capable of communication.
- Children aged 4-6 years
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.
- Parental refusal of participation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo university
Cairo
Lamis A Badawi, 01221184776, lamis.abdelkale@dentistry.cu.edu.eg
About this study
Official title: Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars
To assess the longevity of prefabricated versus conventional band and loop space maintainers in children with prematurely lost first primary molars.
A Randomized Clinical Trial
Read the detailed description
When considering gingival health and cement dissolution, does the longevity of the prefabricated band and loop differ from the conventional band and loop constructed following the premature loss of the lower first primary molars?
The concept of preserving space after premature tooth loss has been recognized for over a century. Conventional appliances are used successfully as space maintainers, but some disadvantages like the need for at least two visits to deliver the appliance due to laboratory work, will definitely affect its role during the general anesthesia.
The prefabricated space maintainer requires only one visit as it is fitted into the patient's mouth at the clinic without needing the dental lab. This provides a good impact on apprehensive children as it reduces the number of visits and chairside time. Prefabricated space maintainers could be a new alternative to the conventional fixed space maintainers used in pediatric dentistry.
- Conditions
- Premature Tooth Exfoliation
- Being tested
- Prefabricated band and loop, Conventional Band and loop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefabricated band and loopDevice
Also called Ready-made band and loop, Chairside band and loop
Prefabricated space maintainer requires only one visit as it fits into the patient's mouth at the clinic without needing the dental lab. It comes in a kit with different band sizes.
Conventional Band and loopDevice
Conventional band and loop is the most widely used space maintainer, It shows high success rate and good patient compliance, but needs more than one visit due to the laboratory work.
| Study group | Role | What they receive |
|---|---|---|
| Conventional band and loop | Active comparator | Conventional band and loop is the most widely used space maintainer, and the most effective. It shows high success rate and good patient compliance, but it needs more than one visit to be applied. Receives: Device: Conventional Band and loop |
| Prefabricated band and loop | Active comparator | Prefabricated space maintainer requires only one visit as it fits into the patient's mouth at the clinic without needing the dental lab. It comes in a kit with different band sizes. Receives: Device: Prefabricated band and loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Health
By using gingival index of Loe and Silness ,scores gingival inflammation from 0-3
0 = normal gingiva
- = mild inflammation: slight change in color, slight edema, no bleeding on probing
- = moderate inflammation: redness, edema, glazing, or bleeding on probing
- = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding
Measured: 3 month and 9 month
Cement integrity
Visual inspection of cement solution by using blunt periodontal explorer and mirror, Binary (Yes, No)
Measured: 3 month and 9 month
Secondary outcomes (2)
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 month and 9 month
Change in arch dimension:
- Arch perimeter: Measured on digital cast as a sum of the incisor, canine and molar segment widths in mm.
- Inter canine width : Measured on 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 month and 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 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 (5)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
- Prevention
- 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, Lamis Abdelkhalek Mohamed Badawi, Cairo University
- Investigators
- Dina Y El Kharadly, Lecturer, Study director, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573463
- Sponsor's protocol ID
- Conventional vs prefabricated
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamki H, Kalaskar R, Balasubramanian S, Badhe H, Kalaskar A. Clinical Effectiveness of Fiber-reinforced Composite Space Maintainer and Band and Loop Space Maintainer in a Pediatric Patient: A Systematic Review and Meta-analysis. Int J Clin Pediatr Dent. 2021;14(Suppl 1):S82-S93. doi: 10.5005/jp-journals-10005-2044.
PubMed 35082473Tahririan 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 31803390Padma Kumari B, Retnakumari N. Loss of space and changes in the dental arch after premature loss of the lower primary molar: a longitudinal study. J Indian Soc Pedod Prev Dent. 2006 Jun;24(2):90-6. doi: 10.4103/0970-4388.26023.
PubMed 16823234Thakur B, Bhardwaj A, Luke AM, Wahjuningrum DA. Effectiveness of traditional band and loop space maintainer vs 3D-printed space maintainer following the loss of primary teeth: a randomized clinical trial. Sci Rep. 2024 Jun 18;14(1):14081. doi: 10.1038/s41598-024-61743-7.
PubMed 38890410Zhao J, Jin H, Li X, Qin X. Dental arch spatial changes after premature loss of first primary molars: a systematic review and meta-analysis of split-mouth studies. BMC Oral Health. 2023 Jun 28;23(1):430. doi: 10.1186/s12903-023-03111-x.
PubMed 37380944
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars
- ClinicalTrials.gov ID
- NCT06573463
- Acronym / sponsor ID
- Conventional vs prefabricated
- 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
- 27 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 longevity of prefabricated versus conventional band and loop space maintainers in children with prematurely lost first primary molars.
A Randomized Clinical Trial
Detailed description
When considering gingival health and cement dissolution, does the longevity of the prefabricated band and loop differ from the conventional band and loop constructed following the premature loss of the lower first primary molars?
The concept of preserving space after premature tooth loss has been recognized for over a century. Conventional appliances are used successfully as space maintainers, but some disadvantages like the need for at least two visits to deliver the appliance due to laboratory work, will definitely affect its role during the general anesthesia.
The prefabricated space maintainer requires only one visit as it is fitted into the patient's mouth at the clinic without needing the dental lab. This provides a good impact on apprehensive children as it reduces the number of visits and chairside time. Prefabricated space maintainers could be a new alternative to the conventional fixed space maintainers used in pediatric dentistry.
Study design
- Primary purpose
- Prevention
- 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 band and loop | Active comparator | Device: Conventional Band and loopConventional band and loop is the most widely used space maintainer, and the most effective. It shows high success rate and good patient compliance, but it needs more than one visit to be applied. |
| Prefabricated band and loop | Active comparator | Device: Prefabricated band and loopPrefabricated space maintainer requires only one visit as it fits into the patient's mouth at the clinic without needing the dental lab. It comes in a kit with different band sizes. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.
- Caries free, or restored mandibular second primary molars and deciduous canines on the side of the extraction maintained throughout the entire follow-up period.
- Children are classified as cooperative or potentially cooperative according to Wright's classification of child behavior.
- According to space analysis, available space is less than or equal to the needed space
- 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 (4 listed)
- 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.
- Parental refusal of participation.
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 band and loopAlso: Ready-made band and loop, Chairside band and loopPrefabricated space maintainer requires only one visit as it fits into the patient's mouth at the clinic without needing the dental lab. It comes in a kit with different band sizes. | Device | Prefabricated band and loop |
| Conventional Band and loopConventional band and loop is the most widely used space maintainer, It shows high success rate and good patient compliance, but needs more than one visit due to the laboratory work. | Device | Conventional band and loop |
Primary outcome
Gingival Health
Time frame: 3 month and 9 month
By using gingival index of Loe and Silness ,scores gingival inflammation from 0-3 0 = normal gingiva 1. = mild inflammation: slight change in color, slight edema, no bleeding on probing 2. = moderate inflammation: redness, edema, glazing, or bleeding on probing 3. = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding
Cement integrity
Time frame: 3 month and 9 month
Visual inspection of cement solution by using blunt periodontal explorer and mirror, Binary (Yes, No)
2 secondary outcomes
Space loss between the abutment teeth.
Time frame: 0 month and 9 month
Change in arch dimension:
Time frame: 0 month and 9 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Background: PubMed 35082473Kamki H, Kalaskar R, Balasubramanian S, Badhe H, Kalaskar A. Clinical Effectiveness of Fiber-reinforced Composite Space Maintainer and Band and Loop Space Maintainer in a Pediatric Patient: A Systematic Review and Meta-analysis. Int J Clin Pediatr Dent. 2021;14(Suppl 1):S82-S93. doi: 10.5005/jp-journals-10005-2044.
- 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 16823234Padma Kumari B, Retnakumari N. Loss of space and changes in the dental arch after premature loss of the lower primary molar: a longitudinal study. J Indian Soc Pedod Prev Dent. 2006 Jun;24(2):90-6. doi: 10.4103/0970-4388.26023.
- Background: PubMed 38890410Thakur B, Bhardwaj A, Luke AM, Wahjuningrum DA. Effectiveness of traditional band and loop space maintainer vs 3D-printed space maintainer following the loss of primary teeth: a randomized clinical trial. Sci Rep. 2024 Jun 18;14(1):14081. doi: 10.1038/s41598-024-61743-7.
- Background: PubMed 37380944Zhao J, Jin H, Li X, Qin X. Dental arch spatial changes after premature loss of first primary molars: a systematic review and meta-analysis of split-mouth studies. BMC Oral Health. 2023 Jun 28;23(1):430. doi: 10.1186/s12903-023-03111-x.
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.
Dina Y El Kharadly, Lecturer study director
October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prefabricated band and loop and Conventional Band and loop in people with Premature Tooth Exfoliation, run by Cairo 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 7 inclusion and 4 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 28 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lamis A Badawi (02001221184776, lamis.abdelkhale@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Health (time frame: 3 month and 9 month). The study lists 2 primary outcomes in all. 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 NCT06573463, which also lists 5 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 28 Aug 2024.