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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Tooth Loss; Edentulous Mouth; Oral Health Quality of Life (OHQoL) Was Assessed
• Intervention / Treatment: Procedure: Full Arch Implant Surgery; Device: Full arch prosthesis

Detailed Description

The aim of this prospective observational cohort study is to evaluate changes in oral health-related quality of life (OHRQoL) during the course of full-arch implant-supported rehabilitation. The study also aims to analyze whether the type of edentulous arch (maxilla or mandible) and the type of prosthetic rehabilitation (e.g. provisional vs definitive, and different prosthetic materials) influence the evolution of OHRQoL and patient satisfaction.

Eligible patients will undergo immediate full-arch implant-supported treatment using 4, 6, or 8 implants per arch, depending on the anatomical and clinical indications. Immediate loading will be achieved through screw-retained acrylic provisional prostheses. After a healing period of 3 to 6 months, a definitive screw-retained prosthesis (monolithic zirconia, veneered zirconia, or hybrid prosthesis) will be delivered.

Patient-reported outcomes will be assessed using three validated instruments:

Oral Health Impact Profile (OHIP-14 PT)

• Assesses perceived oral health-related quality of life.
• Administered at five time points:

T0: Baseline (before surgery)

T1: Day of surgery (calibration)

T2: One month after surgery and provisional prosthesis placement

T3: Prior to definitive prosthesis delivery

T4: One month after definitive prosthesis placement

Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ-PT)

• Evaluates patients' self-perception and psychosocial impact of dental aesthetics.
• Administered at:

T0: Baseline

T2: One month after surgery and provisional prosthesis placement

T4: One month after definitive prosthesis placement

Global Satisfaction Questionnaire

- Custom-made questionnaire with six items assessing patient satisfaction in the following domains:

General condition

Phonetics

Chewing comfort

Prosthesis stability

Ease of cleaning (cleanability)

Aesthetics - Each item is rated using a 4-point Likert scale:

"Very satisfied",

"Mostly satisfied",

"Less satisfied",

"Not at all satisfied".

- Administered at T4 only.

Quantitative data collected from these instruments will be used to analyze the progression of OHRQoL throughout the rehabilitation process and to explore correlations between patient profiles (sociodemographic and clinical variables) and perceived outcomes.

All questionnaires will be administered in Portuguese using secure digital platforms (Google Forms), ensuring patient confidentiality and data integrity.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Artur Filipe Simões; Phone Number: +351962555077; Email: filipesimoesmd@gmail.com

Study Locations

• Portugal
  • Lisbon District
    • Lisbon, Lisbon District, Portugal, 1070-061
      • Recruiting
      • Instituto de Implantologia
      • Contact: Artur Simões

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Device: Full 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Implantology Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: dental implant; oral health; OHIP-14; oral quality of life; outcome studies; Implant-supported prosthesis
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Tooth Loss; Mouth, Edentulous
• Other Study ID Numbers: II2022-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No