Pediatric Dentistry
Conditions
Brief summary
Compare two band and loop space maintainers made from two tooth colored materials; Polyetherethherketone (PEEK) and monolithic Zirconia (BruxZir) as regards to: * Clinical performance of space maintainers in terms of frequency of debonding or fracture of the appliance and health of adjacent gingiva during a one-year follow up. * Wear of the opposing teeth.
Detailed description
After extraction of the mandibular first primary molars in both mandibular quadrants, impressions will be taken with intraoral scanner. Then, it will be sent to the CAD/CAM laboratory to construct functional band and loop space maintainers using PEEK and monolithic zirconia 'BruxZir' blocks with proper shades. After the fabrication of the space maintainers of both sides, they will be cemented with resin luting cement containing MDP monomer. Photographs will be taken after cementation for the space maintainers and the patient will be informed and educated about the oral hygiene measures. The parents will also be inquired to call if any discomfort, debonding or fracture of the appliances happens.
Interventions
OTHERaesthetic functional space maintainers
evaluate the use of Polyetheretherketone 'PEEK' and monolithic zirconia 'Bruxzir' as esthetic functional band and loop space maintainers.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
articipants will be blinded to the type of intervention. Teeth treated will be assigned codes so that outcome evaluators at the follow up appointments are blinded. On the other hand, the operator/ primary investigator cannot be blinded, as she is already familiar with the nature of the materials used. For statistical analysis, codes will also assure blinding and confidentiality. For the patient, both types of space maintainers will have the same color and design.
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical inclusion criteria: * Children requiring bilateral extraction of mandibular first primary molars or those with previously extracted molars no more than 6 months prior to intervention (11) . * Existence of teeth on the mesial and distal side of edentulous area. * Angle's Class I molar relationship and/or flush terminal/mesial step primary molar occlusion Radiographic inclusion criteria: * No periapical and/ or furcural pathological condition related to abutment teeth. * Presence of tooth germ of the succeeding tooth (mandibular first premolars). * Presence of more than 1 mm of bone overlying the successor tooth germ
Exclusion criteria
* Carious abutment teeth requiring pulp therapy. * Carious abutment primary teeth requiring a full coverage restoration. * Patients with history of bruxism or/and clenching. * Patients with medical, intellectual or physical disabilities. * Patients with abnormalities as posterior cross-bite, open bite, and deep bite
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance | 1 year | regarding debonding or fracture of the appliance. if debonding or fracture occur then this means failure. |
| Gingival health | 1 year | Gingival Index of Loe and Silness. where score 0 indicates normal gingiva, score 1 mild inflammation (slight change in color, slight edema but no bleeding on probing. score 2 indicates moderate inflammation (redness, edema, bleeding on probing and score 3 refers to severe inflammation (marked redness, edema, ulceration with sponatnoeus bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wear of the opposing tooth | 1 year | using CAD/CAM software Cerec software (Cerec 4.2, DentsplySirona, Bensheim, Germany)volumetric loss on the surfaces were calculated in the last follow up visit after 1 year |
Countries
Egypt
Contacts
Primary ContactHagar Abozeid, PhD
Backup ContactMariem Wassel, Professor
Outcome results
None listed