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

NCT07568249 | Recruiting

• 1 other identifier: II2022-10
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

dental implant; oral health; outcome studies; oral quality of life; OHIP-14; Implant-supported prosthesis

Outcome Measures

Primary Outcomes (1)

• 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)

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

Study Arms (1)

Full-Arch Immediate Implant-Supported Rehabilitation

Participants will receive a full-arch immediate implant-supported prosthesis over 4, 6 or 8 implants, depending on individual anatomy and clinical indication. Some maxillary cases may require a sinus lift procedure. Immediate loading is performed with a screw-retained provisional prosthesis. After 3-6 months, a definitive prosthesis is delivered Maxillary or/and mandibular screw retained acrylic provisional prostheses supported by at least 4 implants; Maxillary or/and mandibular screw retained hybrid prostheses supported by at least 4 implants; Maxillary or/and mandibular screw retained zirconia monolithic prostheses supported by at least 4 implants

Procedure: Full Arch Implant Surgery; Device: Full arch prosthesis

Interventions

Full Arch Implant Surgery PROCEDURE

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 Immediate Implant-Supported Rehabilitation

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.

Full-Arch Immediate Implant-Supported Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Implantology Institute: lead

Study Sites (2)

Instituto de Implantologia

Lisbon, Lisbon District, 1070-061, Portugal

RECRUITING

Instituto de Implantologia

Lisbon, Lisbon District, 1070-061, Portugal

RECRUITING

MeSH Terms

Conditions

Mouth, Edentulous; Tooth Loss

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Periodontal Diseases

Central Study Contacts

Artur Filipe Simões

CONTACT

+351962555077; filipesimoesmd@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

PT (2)