Edentulous Mouth, Oral Health Quality of Life (OHQoL) Was Assessed, Quality of Life, Tooth Loss
Conditions
Keywords
dental implant, oral health, outcome studies, oral quality of life, OHIP-14, Implant-supported prosthesis, quality of life, oral health quality of life, PIDAQ-PT
Brief summary
Full-arch implant-supported fixed dental prostheses are a widely accepted treatment for edentulous patients, with high long-term implant survival rates. However, further research is needed on longer-term patient satisfaction and on the psychosocial impact of this treatment on patients' daily life and functioning. Assessing patient-reported outcomes - oral health-related quality of life (OHRQoL) and patient satisfaction - allows the impact of full-arch rehabilitation on patients to be evaluated.
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 instruments (two validated questionnaires - OHIP-14 PT and PIDAQ-PT - and one custom-made Global Satisfaction Questionnaire): 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 - Global Satisfaction Questionnaire \[…\] - Administered at two time points: T0: Baseline (before surgery) T4: One month after definitive prosthesis placement 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.
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.
Sponsors
Implantology Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or older. Patients requiring full-arch implant-supported rehabilitation of the maxilla and/or mandible. Patients with indication for immediate full-arch implant-supported rehabilitation using 4, 6, or 8 implants per arch, according to anatomical and clinical conditions. Patients able to understand the study procedures and complete patient-reported outcome questionnaires Patients willing to provide written informed consent.
Exclusion criteria
Patients with medical contraindications for implant surgery. Patients unable to provide informed consent. Patients unable to complete the study questionnaires Patients with uncontrolled systemic conditions that may contraindicate implant therapy. Patients unable or unwilling to attend the planned follow-up visits. Patients receiving partial-arch implant rehabilitation only.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Health-Related Quality of Life measured by the Oral Health Impact Profile-14 Portuguese version | [Time Frame: T0 - baseline before surgery; T1 - day of surgery; T2 - 1 month after surgery and provisional prosthesis placement; T3 - prior to definitive prosthesis delivery (approximately 3 to 6 months); T4 - 1 month after definitive prosthesis placeme | People's perceptions of the social impact of oral disorders on their well-being: oral health quality of life (OHIP-14). Oral health-related quality of life will be assessed using the Portuguese validated version of the Oral Health Impact Profile-14 (OHIP-14). The OHIP-14 includes 14 items, each scored from 0 to 4, generating a total score ranging from 0 to 56. Higher scores indicate poorer oral health-related quality of life and greater negative impact of oral conditions on daily life. The primary outcome will be the change in total OHIP-14 score during full-arch implant-supported rehabilitation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in psychosocial impact of dental aesthetics measured by the Psychosocial Impact of Dental Aesthetics Questionnaire - Portuguese version (PIDAQ-PT) | Time Frame: T0 - baseline before surgery; T2 - 1 month after surgery and provisional prosthesis placement; T4 - 1 month after definitive prosthesis placement (approximately 4 to 7 months from baseline). | The psychosocial impact of dental aesthetics will be assessed using the Portuguese validated version of the PIDAQ (PIDAQ-PT). The PIDAQ-PT comprises 23 items across four subscales (dental self-confidence, social impact, psychological impact, and aesthetic concern), each scored on a 5-point Likert scale (0 to 4). Dental self-confidence items are reverse-scored so that higher total scores indicate a greater negative psychosocial impact of dental aesthetics. The outcome is the change in PIDAQ-PT total and subscale scores during full-arch implant-supported rehabilitation. |
| Patient satisfaction measured by a Global Satisfaction Questionnaire | T0 - baseline before surgery; T4 - 1 month after definitive prosthesis placement (approximately 4 to 7 months from baseline). | Patient satisfaction will be assessed using a custom-made six-item Global Satisfaction Questionnaire covering general condition, phonetics, chewing comfort, prosthesis stability, ease of cleaning (cleanability), and aesthetics. Each item is rated on a 4-point Likert scale ("Very satisfied", "Mostly satisfied", "Less satisfied", "Not at all satisfied"). The outcome is the change in patient satisfaction scores from baseline to after delivery of the definitive prosthesis. |
Countries
Portugal
Contacts
CONTACTArtur F Simões
PRINCIPAL_INVESTIGATORArtur F Simões, Msc
Implantology Institute
STUDY_DIRECTORDuarte Marques, Phd
Implantology Institute
Outcome results
None listed