RecruitingNCT07568249

Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment: A Prospective Study

Sponsor

Implantology Institute

Enrollment

100 participants

Start Date

Nov 1, 2025

Study Type

OBSERVATIONAL

Conditions

Quality of Life Tooth-loss Edentulous Mouth Oral Health Quality of Life (OHQoL) Was Assessed

Summary

Full arch implant-supported fixed dental prosthesis is widely accepted as a treatment modality for edentulous patients, presenting high long-term implant survival rates, although further research is necessary to evaluate patient satisfaction on a longer term and the psycho-social impact of this treatment on the daily life and functioning of patients. Patient-related outcome measures evaluated through oral health-related quality of life (OHRQol) parameters, patient satisfaction and patient preference allows to evaluate the impact of the prosthodontic needs.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

Systemically good health and absence of contraindications for implant therapy, with indication to be rehabilitated with at least one FASISR - maxilla or mandible.

Exclusion Criteria1

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Interventions

PROCEDUREFull Arch Implant Surgery

A surgical and prosthetic treatment involving the placement of 4, 6 or 8 dental implants in the edentulous maxilla or mandible, potentially preceded by sinus augmentation if needed.

DEVICEFull arch prosthesis

This intervention includes the full surgical and prosthetic treatment for edentulous patients undergoing full-arch implant-supported rehabilitation. The treatment consists of two main phases: Immediate implant placement with provisional prosthesis: A surgical procedure is performed for the placement of 4, 6, or 8 implants per arch (maxilla or mandible), with or without sinus augmentation depending on the case. On the same day, a screw-retained acrylic provisional prosthesis is delivered, allowing immediate functional and aesthetic rehabilitation. Definitive prosthesis delivery: After a healing period of approximately 3 to 6 months, once osseointegration and soft tissue stabilization are confirmed, a definitive screw-retained prosthesis is fabricated and delivered. Definitive prostheses may be manufactured from monolithic zirconia, veneered zirconia, or hybrid materials depending on the case. Both prosthetic phases are part of a standardized treatment protocol performed under control.