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

University Hospital Basel

Status: Enrolling

Conditions: Partial Edentulism Kennedy Class 1

Treatments: Device: dental implants and supportive implant components; Device: dental implants and retentive implant components

Study type: Interventional

Funder types: Other

Identifiers

NCT04276246

2019-02167 ex19Joda2;

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Experimental

Experimental group

Description:

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

Treatment:

Device: dental implants and retentive implant components

Control

Experimental group

Description:

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

Treatment:

Device: dental implants and supportive implant components