Mandibular mini-implants supporting new overdentures or existing complete dentures: a randomized controlled clinical study.

Mandibular mini-implants supporting new overdentures or existing complete dentures: a randomized controlled clinical study. - Mini-implant overdentures

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025025

Enrollment

Registered

2021-07-16

Start date

2022-03-01

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous mandible with an insufficient complete denture

Interventions

Group 1: Test group: new overdenture supported by 4 mini-implants Group 2: Control group: conversion of an existing complete denture in a mini-implant-supported overdenture

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Signed informed consent form - Edentulous mandible with an insufficient complete denture (patient’s point of view) - Edentulism in the mandible since at least 6 months - Existing complete dentures (mandible at least 6 months old) - Sufficient complete denture in the maxilla (patient’s point of view) - Presence of an adequate

Exclusion criteria

Exclusion criteria: - Expected treatment need in the maxilla - Known or suspected non-compliance, drug or alcohol abuse - Medical history in which any elective oral surgical intervention would be contraindicated - Heavy smoking (>10 cigarettes/day) - Women who are pregnant or breast feeding at date of inclusion

Design outcomes

Primary

Measure	Time frame
Oral Health-Related Quality of Life (OHRQoL) 5 years after insertion of the final prosthesis, using a questionnaire	—

Secondary

Measure	Time frame
Secondary endpoints will be assessed at insertion of the final prosthesis as well as at each follow-up visit (6 months, 1- / 3- and 5-years): - Technical outcomes - Biological outcomes and complications - Radiographic outcomes - Esthetic outcomes - Patient related outcome measures (PROMS) - Need for maintenance, total cost of the treatment - Masticatory efficiency	—

Countries

Chile, Switzerland

Contacts

Public ContactRiccardo Kraus

Universität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin

riccardo.kraus@zzm.uzh.ch+41 44 634 04 04

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026