Clinical trial NCT05622448: Patient Centered Outcomes and Marginal Bone Changes in CAD/CAM Metallic and (PEEK) Partial Denture Frameworks
Official title: Patient Centered Outcomes and Marginal Bone Changes in CAD/CAM Metallic and Poly Ether Ether Ketone (PEEK) Partial Denture Frameworks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Keywords: peek framework
co-cr framework
removable partial denture
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare PEEK to metallic partial denture frameworks in restoring mandibular Kennedy class I regarding patient satisfaction.

Detailed description: The traditional RPDs with cobalt chromium frameworks and clasps have been proven to be inexpensive, accurate, durable and resistant to distortion .2 On the other hand, they have; unesthetic display of metallic clasps, increased weight, and may provoke an allergic reaction. Because of those drawbacks new metal-free materials have been reported as a replacement of metal alloys in manufacturing RPDs, including; high performance polymers such as polyethylene glycol, polyetherketonketon (PEKK), polyaryletherketone (PAEK) and Polyetheretherketon (PEEK).

Using PEEK and modified PEEK (BioHPP) frameworks were claimed to reduce the distal torqueing and stresses on the abutments in kennedy class I PPDs which is thought to be beneficial for periodontal health of the abutments.10 One of the factors for the dissatisfaction related to the dentures may be attributed to the level of oral perception of each patient. The satisfaction level of the patient is influenced by several factors, including the dentures quality and the plated area, the quality of interaction in the patient-dentist relationship, past experiences with full dentures, and the psychological personality6. In harmony, such factors may promote the improvement of the mastication, the speech, and the aesthetics of the teeth, besides producing less discomfort and pain sensitivity, favoring the comminution of harder food7. However, there are no clinical trials evaluating the effect of PEEK on patient satisfaction and the marginal bone loss around the abutments.

Eligibility criteria: Inclusion Criteria:

1. Patients with bilateral free end saddles in the mandible (kennedy class I) with last standing abutment premolar.
2. Opposing dentition is fully intact or restored.
3. Sufficient inter-arch space.
4. Angle's class I maxilla-mandibular relationship.

Exclusion Criteria:

1. Periodontal affection of the abutment teeth.
2. Skeletal mal-relation.
3. Unmotivated patients to maintain adequate oral hygiene to follow up.
4. Patients with neuromuscular and Psychiatric disorders.
5. Systematic disease affecting bone and periodontal health.
6. Insufficient inter-arch space.
7. Patients with physical reasons that could affect follow up.

Primary outcomes:
measure: patient satisfaction
timeFrame: From enrollment to the last follow up
measure: Oral Health Related quality of life
timeFrame: From enrollment to the last follow up
Secondary outcomes:
measure: Marginal bone changes.
timeFrame: 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References: