NCT06789627

Brief Summary

The aim of this study was to compare CAD Poly ether ether ketone (PEEK) RPD to CAD metallic RPD in treating partial edentulism in terms of Oral health related quality of life

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 2021

Typical duration 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

Study Start

First participant enrolled

October 10, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
Last Updated

January 27, 2025

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

January 17, 2025

Last Update Submit

January 23, 2025

Conditions

Partial EdentulismOral Health-Related Quality of Life

Keywords

CAD/CAMDigital metallic RPDpatient centered outcomes3D printingPEEKOHIP-14

Outcome Measures

Primary Outcomes (1)

  • Oral Health Related Quality of Life (OHRQoL)

    measured by Oral Health Impact Profile- 14 Minimum score 0 , Maximum score 56 higher scores indicate worse OHRQoL

    2 years

Study Arms (2)

RPD with metallic framework

ACTIVE COMPARATOR

Indirectly CAD/CAM produced Metallic framework

Other: RPD with metallic framework

RPD with PEEK framework

EXPERIMENTAL

Indirectly CAD/CAM produced PEEK framework

Other: RPD with PEEK framework

Interventions

RPD with PEEK frameworkOTHER

Indirectly CAD/CAM produced PEEK framework

RPD with PEEK framework
RPD with metallic frameworkOTHER

Indirectly CAD/CAM produced metallic RPD

RPD with metallic framework

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with bilateral free end saddles in the mandible (Kennedy class I) with the last standing abutment second premolar
  • Opposing dentition is fully intact or restored to be intact
  • Adequate inter-arch space of at least 7mm
  • Angle's class I maxilla-mandibular relationship
  • Patients with no periodontal disease and good oral hygiene
  • Cooperative patients showing motivation to follow-up

You may not qualify if:

  • Periodontal affection of the abutment teeth
  • Skeletal mal-relationship
  • Unmotivated patients to maintain adequate oral hygiene and to follow up---- ---- Patients with neuro-mascular disorders
  • Systemic disease affecting periodontal health like uncontrolled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Cairo University

Cairo, Giza Governorate, 0, Egypt

Location

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
Prinicipal investigator

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

October 10, 2021

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

January 27, 2025

Record last verified: 2021-03

Locations

EG(1)