NCT05670899

Brief Summary

comparing retention of CAD CAM metallic and Poly Ether Ether Ketone (PEEK) partial dentures in Kennedy class I casses

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

January 2, 2023

Last Update Submit

January 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • retention

    Measurements are performed for each RPD at the time of denture insertion, after one month and three months later. Measurements were carried out using digital force gauge which is an advanced type of force meter device, used to measure tension or compression up to 20 Kg

    3 months

Study Arms (2)

CAD PEEK frame-work

EXPERIMENTAL

Construction of PEEK framework will be done conventionally by lost wax technique using a vacuum press device. The wax pattern will be invested in a mold using special investment. Then it will be heated and melted to produce a mold into which PEEK will be vacuum pressed. The framework will be fitted on the master cast

Procedure: CAD PEEK frame-work

CAD metallic frame-work

ACTIVE COMPARATOR

A metallic framework will be obtained using the conventional lost wax technique and casting. After de-investing, finishing and polishing, the framework will be fitted on the master cast. Intraoral try in of the framework will be done followed by bite registration record. The next step will be teeth setting and try in. Heat cured acrylic resin denture base will be processed, finished and polished conventionally. The finished removable partial denture will then be checked intraorally for any needed modifications and finally delivered.

Procedure: CAD PEEK frame-work

Interventions

Construction of PEEK framework will be done conventionally by lost wax technique using a vacuum press device. The wax pattern will be invested in a mold using special investment. Then it will be heated and melted to produce a mold into which PEEK will be vacuum pressed. The framework will be fitted on the master cast

CAD PEEK frame-workCAD metallic frame-work

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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. 3- Sufficient inter-arch space. 4- 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, Manial, 11555, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 4, 2023

Study Start

March 20, 2023

Primary Completion

April 20, 2023

Study Completion

August 20, 2023

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations