The Effectiveness of Combined Design Nance/Transpalatal Arch Appliance in Maintaining Arch Dimensions After Premature Extraction of Primary Molars

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effectiveness of Combined Design Nance/Transpalatal Arch Appliance in Maintaining Arch Dimensions After Premature Extraction of Primary Molars (Randomized Controlled Clinical Trial)

Conditions
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Space Maintenance

Intervention / Treatment
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* Device: Nance/Transpalatal arch space maintainer
* Device: Nance space maintainer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fully erupted maxillary permanent first molars. Angle's class I occlusion.(31) Adequate space for premolar eruption according to Moyer's arch length analysis.(31) Fair to good oral hygiene according to Silness and Loe plaque index.(32) No history of allergy to polymethyl methacrylate. Exclusion Criteria: Children with congenitally absent permanent successors. Children with successors not covered by bone with 2/3 of the root formed.(33)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized parallel controlled clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nance space maintainer<br>Conventional space maintainer for the maxillary arch as control | Device: Nance space maintainer<br>* Conventional space maintainer for the maxillary arch used in mixed dentition<br>|
| Experimental: Nance/Transpalatal arch space maintainer<br>New design of a space maintainer for the maxillary arch | Device: Nance/Transpalatal arch space maintainer<br>* A combined design of both Nance and Transpalatal arch space maintainers as a space maintainer for the maxillary arch in mixed dentition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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): Changes in arch circumference after insertion of both Nance and Nance/transpalatal arch (N-TPA) appliances after 3, 6- and 9-months follow-up. Changes in intermolar width after insertion of both Nance and Nance/transpalatal arch (N-TPA) appliances after 3, 6- and 9-months follow-up. Changes in arch depth after insertion of both Nance and Nance/transpalatal arch (N-TPA) appliances after 3, 6- and 9-months follow-up. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nance/transpalatal arch, Nance space maintainer, Space maintainer, Space maintenance