Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prefabricated band and loop, Conventional Band and loop.
- Who it may be relevant to
- Registry conditions: Premature Tooth Exfoliation. Basic parameters: 4 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Longevity of Prefabricated Band and Loop Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars
Overview
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.
Interventions
- Device Prefabricated 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. - Device Conventional Band and loop
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.
Primary outcome measures
- Gingival Health [Time frame: 3 month and 9 month]
- Cement integrity [Time frame: 3 month and 9 month]
Secondary outcome measures (2)
- Space loss between the abutment teeth. [Time frame: 0 month and 9 month]
- Change in arch dimension: [Time frame: 0 month and 9 month]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Cairo university — Cairo
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. PMID 35082473
- 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. PMID 31803390
- Padma 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. PMID 16823234
- Thakur 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. PMID 38890410
- Zhao 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. PMID 37380944
Identifiers
NCT: NCT06573463 · Conventional vs prefabricated