Evaluation of the Success Rate of Prefabricated Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars
- Conditions
- Premature Tooth Exfoliation
- Interventions
- Device: conventional space maintainerDevice: prefabricated space maintainer
- Registration Number
- NCT06558812
- Lead Sponsor
- Cairo University
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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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.
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.
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• 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description conventional space maintainer conventional space maintainer 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. prefabricated space maintainer prefabricated space maintainer 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
- Primary Outcome Measures
Name Time Method appliance success 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 )
- Secondary Outcome Measures
Name Time Method arch dimension 0-9 month measured each of
1. Arch perimeter by measured on a digital cast as a sum of the incisor, canine and molar segment width in mm
2. 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
3. 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• Patient satisfaction during insertion of appliance Patient-reported using 5-point Likert-type scale from 1-5 face scale
• Cost effectiveness through study completion , an average of 9 month Manually by incremental effectiveness cost ratio ,measuring unit is financial units per result
Space loss between the abutment teeth. 0-9 month • 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