Actively Recruiting
Evaluation of Polyetheretherketone and Monolithic Zirconia as Esthetic Functional Space Maintainers in Children (A Randomized Clinical Trial)
Led by Ain Shams University · Updated on 2024-08-19
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on children aged 6 to 11 who need space maintainers after the removal of their lower first primary molars. It compares two types of tooth-colored band and loop space maintainers made from Polyetheretherketone (PEEK) and monolithic Zirconia (BruxZir). The study aims to assess how well these space maintainers perform clinically, including how often they come loose or break, the health of the gums nearby, and the wear on the opposing teeth over one year. After both lower first primary molars are extracted, dental impressions will be taken using an intraoral scanner. These impressions are sent to a CAD/CAM lab where two space maintainers will be made—one from PEEK and one from monolithic zirconia. Once fabricated, both appliances will be cemented in place with a special resin cement. Photos will be taken after placement, and participants and their parents will be informed about oral hygiene and asked to report any issues such as discomfort or damage. Participants will be monitored over a one-year period to evaluate the clinical performance of the space maintainers and the health of the gums next to them. The study team will also assess wear on the teeth opposing the space maintainers. Parents will be asked to notify the team if there are any problems with the appliances. Overall, the trial will help understand how these materials perform for children's dental care needs.
CONDITIONS
Brief Title
Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 11 years
- Require bilateral extraction of mandibular first primary molars or had them extracted within the last 6 months
- Teeth present on both sides of the missing molars
- Angle's Class I molar relationship or flush terminal/mesial step primary molar occlusion
- No periapical or furcal pathology related to abutment teeth on X-ray
- Presence of the tooth germ of the next permanent tooth (mandibular first premolars)
- More than 1 mm of bone above the successor tooth germ
You will not qualify if you...
- Carious abutment teeth needing pulp therapy
- Carious abutment primary teeth needing full coverage restoration
- History of teeth grinding or clenching (bruxism)
- Medical, intellectual, or physical disabilities
- Dental abnormalities such as posterior cross-bite, open bite, or deep bite
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 year
Participants receive esthetic functional space maintainers made from either PEEK or monolithic zirconia after extraction of the mandibular first primary molars. Impressions are taken with an intraoral scanner and the space maintainers are fabricated and cemented with resin luting cement.
1 visit for impression and cementation; parents monitor and report any issues such as discomfort, debonding, or fracture
Trial Site Locations
Total: 1 location
1
Ain Shams University
Cairo, Egypt
Actively Recruiting
Research Team
H
Hagar Abozeid, PhD
M
Mariem Wassel, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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