Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImplantology Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adults with an indication for full-arch screw-retained implant-supported rehabilitation (FASISR) of the maxilla and/or mandible, in generally good systemic health and without contraindications to implant therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Full Arch Implant Surgery
Procedure/SurgeryA 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
DeviceThis 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 groupGroup A: Full-Arch Immediate Implant-Supported Rehabilitation2 interventions
Trial outcomes
Primary outcomes
1
Change in Oral Health-Related Quality of Life measured by the Oral Health Impact Profile-14 Portuguese version
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.
Time frame
[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 placemeSecondary outcomes
1
Change in psychosocial impact of dental aesthetics measured by the Psychosocial Impact of Dental Aesthetics Questionnaire - Portuguese version (PIDAQ-PT)
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.
Time frame
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).2
Patient satisfaction measured by a Global Satisfaction Questionnaire
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.
Time frame
T0 - baseline before surgery; T4 - 1 month after definitive prosthesis placement (approximately 4 to 7 months from baseline).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov