Premature Tooth Exfoliation
Conditions
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
Interventions
DEVICEprefabricated 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,
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 .
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding will not be feasible neither for the operator nor the patient. As there are some differences in the clinical steps, the form of the appliances and number of needed visits. Outcome assessor and Statistician will be blinded from the intervention and control not knowing which group represents which procedure.
Intervention model description
A randomized controlled clinical trial, parallel group, allocation ratio 1:1 Framework superiority
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Contacts
Primary Contactamal fathi mahmoud sakr sakr
Backup ContactDr.Sherif Bahgat El Tawil El Tawil, professor
Outcome results
None listed