An interventional study of prefabricated space maintainer and conventional space maintainer in Premature Tooth Exfoliation, sponsored by Cairo University. Not yet recruiting. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Clinical criteria Medically free children.
Radiographic criteria
Exclusion Criteria:
Children with any parafunctional habits.
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.
Device: conventional 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
Device: prefabricated space maintainer
i. 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,
Also known as: chair side space maintainer
i. 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 .
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 )
Time frame: 0-3-9 month
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
Time frame: 0-9 month
arch dimension
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
Time frame: 0-9 month
• Patient satisfaction
Patient-reported using 5-point Likert-type scale from 1-5 face scale
Time frame: during insertion of appliance
• Cost effectiveness
Manually by incremental effectiveness cost ratio ,measuring unit is financial units per result
Time frame: through study completion , an average of 9 month
No study locations are listed for this record.
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Cairo University