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

ConditionsEdentulous Mouth Quality of Life Tooth Loss Oral Health Quality of Life (OHQoL) Was Assessed

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorImplantology Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Full Arch Implant Surgery
Procedure/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.
Full arch prosthesis
Device
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.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Full-Arch Immediate Implant-Supported Rehabilitation2 interventions

Trial outcomes

Primary outcomes

Oral Quality of Life

People's perceptions of the social impact of oral disorders on their well-being: oral health quality of life (OHIP-14)

Time frame

From enrollment to the end of the treatment - final rehabilitation placed - 1 month after

Sponsors and contacts

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Implantology Institute

Lead sponsor

Source ClinicalTrials.gov

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