Within-subject comparison of fixed and removable locator prostheses in the edentulous maxilla: A crossover randomized clinical trial

Within-subject comparison of fixed and removable locator prostheses in the edentulous maxilla: A crossover randomized clinical trial - Locator fixed study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039451

Enrollment

Registered

2026-02-25

Start date

2026-05-01

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

K08.1

Interventions

Group 1: Rehabilitation of the edentulous maxilla with four implants and implant-supported prostheses in two variants. Sequence (Arm 1): fixed restoration ? after 3 months switch to removable ? after

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Willingness to participate Ability to comply with the study protocol Signed informed consent Edentulous maxilla

Exclusion criteria

Exclusion criteria: Systemic/local contraindications to implant treatment Medications that affect bone metabolism Oromaxillofacial radiotherapy > 50 Gy (within the last 5 years) Severe bruxism/teeth grinding Smoking (> 10 cigarettes/day) Pregnancy/breastfeeding Non-compliance with treatment instructions; drug/alcohol abuse Removable mandibular complete denture

Design outcomes

Primary

Measure	Time frame
Oral health–related quality of life, measured with the OHIP 14 questionnaire at 12 months.	—

Secondary

Measure	Time frame
Assessment of satisfaction using a VAS-based questionnaire after 3 months of wearing each type of restoration. Masticatory efficiency and bite force (bite force measurement with the T-Scan Novus and a two-colour chewing gum test); decision for the restorative variant (removable vs fixed). Complications. Costs of the restoration. Long-term outcomes over a five-year follow-up: Implant survival (clinical examination and routine follow-up radiographs). Implant success. Frequency of complications. Costs of complication management.	—

Measure

Time frame

Assessment of satisfaction using a VAS-based questionnaire after 3 months of wearing each type of restoration. Masticatory efficiency and bite force (bite force measurement with the T-Scan Novus and a two-colour chewing gum test); decision for the restorative variant (removable vs fixed). Complications. Costs of the restoration. Long-term outcomes over a five-year follow-up: Implant survival (clinical examination and routine follow-up radiographs). Implant success. Frequency of complications. Costs of complication management.

—

Countries

Brazil, Germany

Contacts

Public ContactStefan Wentaschek

Klinik für Zahnärztliche Prothetik und Werkstoffkunde

wentasch@uni-mainz.de+49 6131 17-2211

Outcome results

None listed

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