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This study will evaluate the effectiveness of N-TPA appliance compared to Nance SM in maintaining the arch dimensions after bilateral premature extraction of primary molars in children.
In this randomized controlled clinical trial, 30 healthy children, 8-9 years of age with premature extraction of bilateral maxillary primary molars will be selected. Children will be randomly allocated into two equal groups of 15 children each according to the type of the appliance that will be used. Group I will receive a a Nance SM, and Group II a combined N-TPA appliance . Panoramic X-rays and study casts will be made, and baseline measurements will be recorded including arch circumference, intermolar width and arch depth. The appliances will be fabricated and cemented intra-orally.
The patients will be followed up at 3, 6 and 9 months for re-evaluation of arch circumference, intermolar width, arch depth, and patient acceptance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nance space maintainer | Active Comparator | Conventional space maintainer for the maxillary arch as control |
|
| Nance/Transpalatal arch space maintainer | Experimental | New design of a space maintainer for the maxillary arch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nance/Transpalatal arch space maintainer | Device | A combined design of both Nance and Transpalatal arch space maintainers as a space maintainer for the maxillary arch in mixed dentition |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy in maintaining arch dimensions | All arch dimensions are measured with a 0.5 mm stainless steel wire on the study casts which was then measured with a digital caliper in millimeters (accuracy up to 0.02mm):
| 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient acceptance by modified faces pain scale | Patient acceptance are measured by the modified faces pain scale of both Nance and N-TPA appliances after 3, 6- and 9-months follow-up. Patient acceptance is measured as : (a) Satisfied (b) Indifferent (c) Dissatisfied | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry, Alexandria University | Alexandria | Egypt |
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Randomized parallel controlled clinical trial
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| Nance space maintainer | Device | Conventional space maintainer for the maxillary arch used in mixed dentition |
|