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

NCT04276246 | Recruiting

• 1 other identifier: 2019-02167; ex19Joda2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Partial Edentulism Kennedy Class 1

Keywords

Partial Edentulism; Kennedy Class 1; Removable partial dentures (RPDs); Supplementary implants

Outcome Measures

Primary Outcomes (2)

• Changes in patient-reported outcome measures (PROM)

  Assessment of patient's perception of function and oral health comparing conventional RPDs to implant-supported RPDs with and without retentive components in posterior sites of Kennedy Class I. PROMs are evaluated using the Oral Health Impact Profile (OHIP 14), i.e. the short form of OHIP with 14 items measuring oral health-related quality of life (OHQoL). The frequency of impairment in different areas (functional limitation, physical discomfort or disability, psychological discomfort or disability, social disability, and handicap) are indicated on a multi-level scale ("never"=0, "hardly"=1, "sometimes"=2, "often"=3, "very often"=4)

  assessment before implant placement, -1 week and 3 months after RPD insertion, 1 week and 3 months after connecting the implant components, 1 to 5 years after implant placement (5-year study period)

• Changes in chewing efficiency

  Assessment of the chewing Efficiency by masticating standardized fruit gum with three varying degree of hardness. A complete chewing function test comprises 9 chewing sequences: the different hardness of the model food is chewed once on the right, then on the left and finally on both sides. The study participants have 30 seconds for each chewing sequence and 30 seconds between each chewing sequence. Only one fruit gum is chewed per chewing sequence. The samples are placed on a defined area, photographed in standardized manner and analyzed with a computer program. The mean size and amounts of the chewed particles are calculated and determines the chewing efficiency

  assessment before implant placement, -1 week and 3 months after RPD insertion, 1 week and 3 months after connecting the implant components, 1 to 5 years after implant placement (5-year study period)

Secondary Outcomes (3)

• prosthetic and implant survival rates

  during follow-ups, 1 of 5 years after implant placement

• cost-benefit-analyses

  during follow-ups, 1 of 5 years after implant placement

• Evaluation of success of entire treatment

  during follow-ups, 1 of 5 years after implant placement

Study Arms (2)

Experimental

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

Device: dental implants and retentive implant components

Control

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

Device: dental implants and supportive implant components

Interventions

dental implants and retentive implant components DEVICE

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

Experimental

dental implants and supportive implant components DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

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

Basel, 4058, Switzerland

RECRUITING

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Nicola Zitzmann, Prof. Dr.

CONTACT

+41 61 267 26 31; n.zitzmann@unibas.ch

Tim Joda, Prof. Dr.

CONTACT

+41 61 267 26 31; tim.joda@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 19, 2020
• Study Start: February 6, 2020
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

CH (1)