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

Primary Purpose

Space Maintenance

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nance/Transpalatal arch space maintainer
Nance space maintainer
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Space Maintenance focused on measuring Nance/transpalatal arch, Nance space maintainer, Space maintainer, Space maintenance

Eligibility Criteria

8 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Faculty of dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nance space maintainer

Nance/Transpalatal arch space maintainer

Arm Description

Conventional space maintainer for the maxillary arch as control

New design of a space maintainer for the maxillary arch

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2022
Last Updated
August 22, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05514145
Brief Title
The Effectiveness of Combined Design Nance/Transpalatal Arch Appliance in Maintaining Arch Dimensions After Premature Extraction of Primary Molars
Official Title
The Effectiveness of Combined Design Nance/Transpalatal Arch Appliance in Maintaining Arch Dimensions After Premature Extraction of Primary Molars (Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Space Maintenance
Keywords
Nance/transpalatal arch, Nance space maintainer, Space maintainer, Space maintenance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized parallel controlled clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nance space maintainer
Arm Type
Active Comparator
Arm Description
Conventional space maintainer for the maxillary arch as control
Arm Title
Nance/Transpalatal arch space maintainer
Arm Type
Experimental
Arm Description
New design of a space maintainer for the maxillary arch
Intervention Type
Device
Intervention Name(s)
Nance/Transpalatal arch space maintainer
Intervention Description
A combined design of both Nance and Transpalatal arch space maintainers as a space maintainer for the maxillary arch in mixed dentition
Intervention Type
Device
Intervention Name(s)
Nance space maintainer
Intervention Description
Conventional space maintainer for the maxillary arch used in mixed dentition
Primary Outcome Measure Information:
Title
Efficacy in maintaining arch dimensions
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Patient acceptance by modified faces pain scale
Description
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
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Faculty of dentistry, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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