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Compare two band and loop space maintainers made from two tooth colored materials; Polyetherethherketone (PEEK) and monolithic Zirconia (BruxZir) as regards to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| polyetheretherketone | Active Comparator | PEEK 'Polyetheretherketone' Victrex® is a type of polymer with suitable mechanical and physical properties. It is a resilient material with high flexural strength and resistance to deformation. Therefore, it can be used in fixed prosthesis and space maintainers |
|
| monolithic zirconia | Active Comparator | BruxZir® is a type of monolithic zirconia with higher flexural strength and fracture toughness than the classic zirconia and can withstand the changes in temperature in the oral cavity. Therefore it can be used as a space maintainer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aesthetic functional space maintainers | Other | evaluate the use of Polyetheretherketone 'PEEK' and monolithic zirconia 'Bruxzir' as esthetic functional band and loop space maintainers. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance | regarding debonding or fracture of the appliance. if debonding or fracture occur then this means failure. | 1 year |
| Gingival health | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Wear of the opposing tooth | 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 | 1 year |
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Inclusion Criteria:
Clinical inclusion criteria:
Radiographic inclusion criteria:
Exclusion Criteria:
Carious abutment teeth requiring pulp therapy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hagar Abozeid, PhD | Contact | 0201110611169 | Hagar_abozeid_22@hotmail.com | |
| Mariem Wassel, Professor | Contact | 01064871416 |
| Name | Affiliation | Role |
|---|---|---|
| Nagwa Khattab, Professor | Ainshams U | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | Egypt |
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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.