Clinical trial NCT06700733: PEEK Vs Titanium for All-on-4 Prosthesis
Official title: Polyetheretherketone (PEEK) Versus Titanium Frameworks for All-on-4 Implant Full-arch Prosthesis: Within-patient Evaluation of Patient Satisfaction, Oral Health-related Quality of Life (OHRQoL), Chewing Efficiency and Maximum Bite Force
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction, Patient
Bite Force
Keywords: PEEK
Titanium
All-on-4
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 18
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All selected patients will receive maxillary complete dentures and mandibular screw-retained prosthesis either from PEEK or Titanium framework in a crossover design.
Primary purpose: TREATMENT

Brief summary: This crossover clinical study will examine the impact of the framework material of implant-supported prostheses on patient satisfaction and Oral Health-Related Quality of Life (OHRQoL) with mandibular All-on-4 implant distribution. The trial will investigate subject satisfaction, OHRQoL as the primary outcome, and chewing efficiency and maximum bite force as secondary outcomes for different framework materials used in implant-supported screw-retained restorations. The first null hypothesis states no significant difference in patient satisfaction and OHRQoL between the tested prostheses. Additionally, the second null hypothesis states no significant difference in chewing efficiency and maximum bite force between the tested prostheses.

Detailed description: Prosthetic steps

1. For each patient, an abutment-level impression will be made, and the resultant cast will be 3D scanned for CAD/CAM construction of a PEEK superstructure with abutments.
2. A verification jig will be constructed to ensure the accuracy of the cast.
3. The final prosthesis will be virtually planned by using the Exo-Cad software.
4. The final prosthesis will be milled in Duralay polymerized resin disk, and the prosthesis resin pattern will be tried intra-orally for passive fit using a screw test.
5. For the PP, The PEEK framework will be constructed, the fit of the PEEK framework will be verified intraorally, and the final screw-retained prosthesis will be constructed of PMMA teeth and a visiolign pink composite estimating the gingival tissue.
6. For the TP, the framework will be milled from Ti blocks according to the virtual design of the final prosthesis framework. PMMA teeth then will be cemented, and the final prosthesis will be screwed.

Evaluation

1. Patient satisfaction (VAS) Patient satisfaction will be evaluated using a questionnaire based on a visual analog scale (VAS).(21) Patients will be asked to mark their answer (amount of satisfaction) on a 100-mm line (with zero referring to not satisfied at all and 100 referring to completely satisfied). The mean of the answers (length of the lines from zero to the marks in mm) for each question was subjected to statistical analysis.
2. Oral health-related quality of life (OHIP-14) The oral health impact profile (OHIP-14) questionnaire was used to measure OHRQoL. The full OHIP questionnaire consisted of 49 items covering seven main domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, and social disability. The OHIP-14 questionnaires were translated into Arabic by linguistic professionals who worked in collaboration with the authors to prepare the final version.
3. Evaluation of masticatory efficiency: Chewing efficiency will be evaluated using the color mixing ability test.
4. Evaluation of maximum bite force (BF): A digital BF transducer will be used to evaluate maximum BF in Newton (N).

Eligibility criteria: Inclusion Criteria:

The inclusion criteria include

* healthy male patients free from systemic diseases that may affect bone health, such as uncontrolled diabetes mellitus and osteoporosis.
* implants placed with the All-on-4 concept in the mandible.

Exclusion Criteria:

* The exclusion criteria: the patients with a history of parafunctional habits (bruxism and clenching), smoking, and alcoholism

Primary outcomes:
measure: patient satisfaction
timeFrame: 3 month
measure: chewing efficiency
timeFrame: 3 month
Secondary outcomes:
measure: Oral health-related quality of life (OHRQoL)
timeFrame: 3 month
measure: maximum bite force (BF)
timeFrame: 3 month
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Khloud Ezzat
Study officials:
affiliation: Lecturer
name: Khloud Ezzat, PhD
role: PRINCIPAL_INVESTIGATOR
References: