Masticatory Efficiency, Bite Force, and Patient-Reported Outcomes in Patients Rehabilitated With Complete and Partial Dentures Supported by Teeth, Mini-Implants, or Conventional Implants

NCT07639112 | Active Not Recruiting DMC

• 2 other identifiers: SFZG-PROS-IMPL2026SFZG-06-2025 (INOVA-Dent-KPI)
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate masticatory efficiency, bite force, and patient-reported outcomes in edentulous and partially edentulous patients rehabilitated with different removable prosthodontic treatment modalities. The study includes both cross-sectional and longitudinal components. The cross-sectional component will compare patients wearing conventional complete dentures, conventional removable partial dentures, mini-implant-retained overdentures, conventional implant-retained overdentures, and implant-assisted removable partial dentures. The longitudinal component will assess changes in masticatory performance, bite force, and patient-reported outcomes following prosthodontic rehabilitation and adaptation over time. The study seeks to determine whether implant-assisted treatment options provide superior functional outcomes, oral health-related quality of life, and patient satisfaction compared with conventional removable prostheses.

Conditions

Edentulism; Edentulism Complete; Mini Dental Implants; Masticatory Function; Partial Edentulism; Complete Dentures; Removable Partial Denture; Implant Supported Overdenture; Implant- Asissted Removable Partial Denture; Mastication; Prosthodontics; Oral Health Quality of Life (OHQoL) Was Assessed; Bite Force; Patients Reported Outcomes; OHIP

Keywords

mini dental implants; Masticatory Efficiency; Bite Force; OHIP; Chewing Function Questionnaire; Patient-Reported Outcomes; Oral Health-Related Quality of Life; Complete Denture; Removable Partial Denture; Implant-Retained Overdenture; Implant-Assisted Removable Partial Denture; Implant overdenture; Edentulous Patients; Partially Edentulous Patients; Prosthodontic Rehabilitation; Chewing Ability; Orofacial Esthetics

Outcome Measures

Primary Outcomes (1)

• Masticatory Efficiency

  Assessment of masticatory efficiency using a standardized two-color chewing-gum mixing ability test. The degree of color mixing will be quantified using digital image analysis.

  Cross-sectional component: at study enrollment. Longitudinal component: baseline (before treatment), prosthesis delivery, 3 months, and 12 months after treatment.

Secondary Outcomes (6)

• Maximum Bite Force

  At study enrollment; baseline, prosthesis delivery, 3 months, and 12 months after treatment.

• Oral Health-Related Quality of Life (OHIP)

  At study enrollment; baseline, 3 months, and 12 months after treatment.

• Self-Perceived Chewing Function (CFQ)

  At study enrollment; baseline, 3 months, and 12 months after treatment.

• Orofacial Esthetics (OES)

  At study enrollment; baseline, 3 months, and 12 months after treatment.

• Residual Ridge Morphology

  At study enrollment and baseline before treatment.

Study Arms (6)

Conventional Complete Dentures (CD)

Edentulous participants rehabilitated with conventional maxillary and mandibular complete dentures.

Two Standard Implant Overdentures (2-IOD)

Edentulous participants rehabilitated with mandibular overdentures retained by two conventional dental implants and opposed by maxillary complete dentures.

Four Mini-Implant Overdentures (4-MDI-OD)

Edentulous participants rehabilitated with mandibular overdentures retained by four mini dental implants and opposed by maxillary complete dentures.

Conventional Removable Partial Dentures (RPD)

Partially edentulous participants rehabilitated with conventional removable partial dentures.

Mini-Implant-Assisted RPD (MDI-RPD)

Partially edentulous participants rehabilitated with removable partial dentures assisted by mini dental implants.

Implant-Assisted RPD (IARPD)

Partially edentulous participants rehabilitated with removable partial dentures assisted by conventional dental implants.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise edentulous and partially edentulous adult patients treated at the Department of Prosthodontics, University of Zagreb School of Dental Medicine. Participants will include wearers of conventional complete dentures, conventional removable partial dentures, mini-implant-retained overdentures, conventional implant-retained overdentures, mini-implant-assisted removable partial dentures, and implant-assisted removable partial dentures. Additional participants undergoing prosthodontic rehabilitation will be prospectively recruited for the longitudinal component of the study.

You may qualify if:

• Age 18 years or older.
• Ability to understand the study procedures and provide written informed consent.
• Wearing the respective prosthodontic restoration for at least 6 months (cross-sectional component).
• Planned rehabilitation with one of the investigated prosthodontic treatment modalities (longitudinal component).
• Ability to perform masticatory tests and complete questionnaires.

You may not qualify if:

• Severe cognitive impairment or inability to complete questionnaires.
• Neurological or muscular disorders affecting mastication.
• Acute oral infections or untreated oral pathology.
• Severe temporomandibular disorders causing pain or functional limitation.
• Implant or prosthesis failure requiring immediate treatment.
• Any medical condition that, in the opinion of the investigators, could affect study participation or outcome assessment.

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (2)

School of Dental Medicine, University of Zagreb

Zagreb, City of Zagreb, 10000, Croatia

Location

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

Location

Study Officials

• Sanja Persic Kirsic, Phd, Associate Professor

  School of Dental Medicine University of Zagreb

  PRINCIPAL INVESTIGATOR

• Sanja Persic Kirsic

  School of Dental Medicine University of Zagreb

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: June 14, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CR (2)