Supplementary Implants Supporting Conventional Removable Dental Prosthesis (RDPs) in Kennedy Class I

NCT ID: NCT04276246

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-06

Study Completion Date

2026-02-28

Brief Summary

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In this study the additional effect of supplementary implants in patients with Kennedy Class I in terms of patient-reported outcome measures (PROMs) and cost-benefit-analyses comparing costs of maintenance care will be investigated

Detailed Description

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Conditions

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Partial Edentulism Kennedy Class 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental

All included participants receive each side 1 posterior implant in the edentulous areas bilaterally in Kennedy class I. Participants are provided with a conventional clasp retained removable partial denture (RPD) worn for 3 months. When implant osseointegration is ensured (3 months healing period), patients are assigned to retentive components (Group A, Test) which are connected to the implants to retain the RPD

Group Type EXPERIMENTAL

dental implants and retentive implant components

Intervention Type DEVICE

retentive components (Group A Test), which are connected to the implants to retain the RPD

Control

All included participants receive each side 1 posterior implant in the edentulous areas bilaterally in Kennedy class I. Participants are provided with a conventional clasp retained removable partial denture (RPD) worn for 3 months. When implant osseointegration is ensured (3 months healing period), patients are assigned to supportive components (Group B, Control), which are connected to the implants to support the RPD

Group Type EXPERIMENTAL

dental implants and supportive implant components

Intervention Type DEVICE

supportive components (Group B Control), which are connected to the implants to support the RPD

Interventions

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dental implants and retentive implant components

retentive components (Group A Test), which are connected to the implants to retain the RPD

Intervention Type DEVICE

dental implants and supportive implant components

supportive components (Group B Control), which are connected to the implants to support the RPD

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects must have voluntarily signed the informed consent before any study action, are willing and able to attend scheduled follow-up visits, and agree that the encoded data will be collected and analyzed
* Males and females with at least 18 years of age
* intraoral situation with bilateral edentulous areas located posterior to the remaining natural teeth (Kennedy class I) in the upper or lower jaw
* remaining dentition includes a first premolar, canine or incisor as the most posterior tooth

Exclusion Criteria

* Uncontrolled systemic disease that would interfere with dental implant therapy;
* Patients who smoke \> 10 cigarettes per day or tobacco equivalents;
* Patients with alcohol and/or drug abuse;
* Patients with chronic pain;
* Patients with untreated periodontitis and / or inadequate oral hygiene (Plaque Index \< 30%);
* Medical conditions requiring chronic high dose steroid therapy or anti-resorptive treatment;
* Conditions or circumstances, in the opinion of the investigators, which would prevent completion of study participation or interfere with analysis of study results such as history of non-compliance or unreliability.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ITI International Team for Implantology, Switzerland

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Reconstructive Dentistry, University Center for Dental Medicine Basel UZB, University of Basel

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Nicola Zitzmann, Prof. Dr.

Role: CONTACT

+41 61 267 26 31

Tim Joda, Prof. Dr.

Role: CONTACT

+41 61 267 26 31

Facility Contacts

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Nicola Zitzmann, Prof. Dr.

Role: primary

+41 61 267 26 31

Tim Joda, Prof. Dr.

Role: backup

+41 61 267 26 31

Other Identifiers

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2019-02167; ex19Joda2

Identifier Type: -

Identifier Source: org_study_id

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