NCT07849972

Brief Summary

This study evaluates and compares the clinical performance, retention, and patient satisfaction between Polyetheretherketone (PEEK) and Cobalt-Chromium (Co-Cr) digital telescopic mandibular removable partial dentures. Patients requiring mandibular telescopic removable partial dentures receive digitally fabricated prostheses to assess retention, abutment tooth preservation, periodontal indices, and patient satisfaction over a 12-month follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

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

December 28, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

2.5 years

First QC Date

September 24, 2026

Last Update Submit

September 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prosthetic Retention

    Retention force of PEEK vs Co-Cr telescopic dentures measured using a digital force gauge in Newtons.

    Baseline, 6 months, and 12 months

Study Arms (2)

PEEK Telescopic RPD

EXPERIMENTAL

Patients receiving digitally fabricated Polyetheretherketone (PEEK) telescopic mandibular

Device: PEEK Telescopic Removable Partial DentureDevice: Co-Cr Telescopic Partial Denture

Co-Cr Telescopic RPD

ACTIVE COMPARATOR

Patients receiving digitally fabricated Cobalt-Chromium (Co-Cr) telescopic mandibular removable partial dentures.

Device: PEEK Telescopic Removable Partial DentureDevice: Co-Cr Telescopic Partial Denture

Interventions

Digitally fabricated Cobalt-Chromium (Co-Cr) telescopic mandibular removable partial denture.

Co-Cr Telescopic RPDPEEK Telescopic RPD

Polyetheretherketone (PEEK) telescopic mandibular removable partial denture.

Co-Cr Telescopic RPDPEEK Telescopic RPD

Eligibility Criteria

Age40 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mandibular Kennedy Class I partially edentulous arches. Terminal abutment is bilateral mandibular second premolar. Maxillary arch dentulous or with fixed prostheses. Age 40-50 years. Good oral hygiene and healthy periodontal condition. Healthy mucosa without inflammation or flabby tissues. Teeth free from mobility. Free from systemic, metabolic, or bone diseases.

You may not qualify if:

  • Parafunctional habits (bruxism/clenching). Xerostomia or excessive salivation. Temporomandibular joint disorders. Insufficient interarch space. Uncooperative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine, Al-Azhar University

Cairo, Cairo Governorate, 11884, Egypt

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist at Medical Administration Al-Azhar University

Study Record Dates

First Submitted

September 24, 2026

First Posted

September 30, 2026

Study Start

December 28, 2023

Primary Completion

June 21, 2026

Study Completion

June 21, 2026

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations