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

• Sponsor: Cairo University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05622448
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Patient Satisfaction	Other: RPD with PEEK framework; Other: RPD with metallic framework	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RPD with metallic framework removable partial denture with cobalt chromium framework	Other: RPD with PEEK framework; removable partial denture with CAD designed PEEK framework; Other: RPD with metallic framework; removable partial denture with cobalt chromium framework
Experimental: RPD with PEEK framework removable partial denture with poly ether ether ketone framework	Other: RPD with PEEK framework; removable partial denture with CAD designed PEEK framework; Other: RPD with metallic framework; removable partial denture with cobalt chromium framework

Outcome Measures

Primary Outcome Measures

1. patient satisfaction [3 months]

   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)

Secondary Outcome Measures

1. Marginal bone changes. [6 months]

   Radiographic follow up will be performed for marginal bone changes.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	Cairo		Egypt	1234

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arwa Sedky Abd El-lateef, doctor, Cairo University
• ClinicalTrials.gov Identifier: NCT05622448
• Other Study ID Numbers: patient satisfaction and RPD
• First Posted: Nov 18, 2022
• Last Update Posted: Nov 18, 2022
• Last Verified: Nov 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Arwa Sedky Abd El-lateef, doctor, Cairo University: peek framework; co-cr framework; removable partial denture

Study Results

No Results Posted as of Nov 18, 2022