Patient Satisfaction and Marginal Bone Changes in CAD Metallic and (PEEK) Partial Denture Frameworks

Patient Satisfaction Clinical Trial

Official title:

Patient Satisfaction and Marginal Bone Changes in CAD Metallic and Poly Ether Ether Ketone (PEEK) Partial Denture Frameworks in Mandibular Kennedy Class I Patients: A Randomized Clinical Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05622448
• Other study ID #: patient satisfaction and RPD
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 30, 2022
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Patient Satisfaction

Intervention

Other:
• RPD with PEEK framework
removable partial denture with CAD designed PEEK framework
• RPD with metallic framework
removable partial denture with cobalt chromium framework

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient satisfaction	Patient satisfaction will be measured using a valid and reliable questionnaire which is Patient satisfaction with lower removable denture questionnaire SLRD-Q.; likert scale ranges from very good (1) to good (2), neither good nor bad (3), bad (4), and extremely bad (5)	3 months
Secondary	Marginal bone changes.	Radiographic follow up will be performed for marginal bone changes.	6 months