Space Maintenance
Conditions
Keywords
Nance/transpalatal arch, Nance space maintainer, Space maintainer, Space maintenance
Brief summary
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
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.
Interventions
DEVICENance/Transpalatal arch space maintainer
A combined design of both Nance and Transpalatal arch space maintainers as a space maintainer for the maxillary arch in mixed dentition
DEVICENance space maintainer
Conventional space maintainer for the maxillary arch used in mixed dentition
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized parallel controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
8 Years to 9 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy in maintaining arch dimensions | 9 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient acceptance by modified faces pain scale | 9 months | 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 |
Countries
Egypt
Outcome results
None listed