NCT05622448

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 5, 2025

Status Verified

November 1, 2022

Enrollment Period

2.7 years

First QC Date

July 18, 2019

Last Update Submit

February 1, 2025

Conditions

Patient Satisfaction

Keywords

peek frameworkco-cr frameworkremovable partial denture

Outcome Measures

Primary Outcomes (2)

  • 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)

    From enrollment to the last follow up

  • Oral Health Related quality of life

    From enrollment to the last follow up

Secondary Outcomes (1)

  • Marginal bone changes.

    2 years

Study Arms (2)

RPD with metallic framework

ACTIVE COMPARATOR

removable partial denture with cobalt chromium framework

Other: RPD with PEEK frameworkOther: RPD with metallic framework

RPD with PEEK framework

EXPERIMENTAL

removable partial denture with poly ether ether ketone framework

Other: RPD with PEEK frameworkOther: RPD with metallic framework

Interventions

RPD with PEEK frameworkOTHER

removable partial denture with CAD designed PEEK framework

RPD with PEEK frameworkRPD with metallic framework
RPD with metallic frameworkOTHER

removable partial denture with cobalt chromium framework

RPD with PEEK frameworkRPD with metallic framework

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, 1234, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

July 18, 2019

First Posted

November 18, 2022

Study Start

October 1, 2019

Primary Completion

June 1, 2022

Study Completion

December 30, 2023

Last Updated

February 5, 2025

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)