Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children
- Conditions
- Pediatric Dentistry
- Interventions
- Other: aesthetic functional space maintainers
- Registration Number
- NCT06558968
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description polyetheretherketone aesthetic functional space maintainers 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 aesthetic functional space maintainers 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Ain Shams University
🇪🇬Cairo, Egypt