Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Changes in Oral Health-related Quality of Life ( OHRQoL) Full Arch Implant Treatment: A Prospective Study
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Artur F Simões
- Telefonnummer: +351962555077
- E-post: filipesimoesmd@gmail.com
Studieorter
-
-
Lisbon District
-
Lisbon, Lisbon District, Portugal, 1070-061
- Rekrytering
- Instituto de Implantologia
-
Huvudutredare:
- Duarte Marques, Phd
-
Kontakt:
- Artur F Simões
-
Huvudutredare:
- Artur F Simões, Msc
-
Huvudutredare:
- João M Caramês, Phd
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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 |
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.
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Oral Health-Related Quality of Life measured by the Oral Health Impact Profile-14 Portuguese version
Tidsram: [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. |
[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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in psychosocial impact of dental aesthetics measured by the Psychosocial Impact of Dental Aesthetics Questionnaire - Portuguese version (PIDAQ-PT)
Tidsram: 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.
|
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).
|
|
Patient satisfaction measured by a Global Satisfaction Questionnaire
Tidsram: 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.
|
T0 - baseline before surgery; T4 - 1 month after definitive prosthesis placement (approximately 4 to 7 months from baseline).
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Artur F Simões, Msc, Implantology Institute
- Studierektor: Duarte Marques, Phd, Implantology Institute
Publikationer och användbara länkar
Allmänna publikationer
- Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
- Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
- Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
- João Almeida Amaral, Duarte Marques, João Godinho, Filipe Barcelos, José Vaz Patto, António Mata, # 7. Validação de uma versão portuguesa do questionário Oral Health Impact Profile-14, Revista Portuguesa de Estomatologia, Medicina Dentária e Cirurgia Maxilofacial, Volume 55, Supplement 1, 2014, Page e4, ISSN 1646-2890, https://doi.org/10.1016/j.rpemd.2014.11.117. (https://www.sciencedirect.com/science/article/pii/S1646289014002039)
- Fidalgo J, Botelho J, Proenca L, Mendes JJ, Machado V, Delgado AS. Cross-Cultural Adaptation and Validation of the Portuguese Version of the Psychosocial Impact of Dental Aesthetics Questionnaire. Int J Environ Res Public Health. 2022 Aug 11;19(16):9931. doi: 10.3390/ijerph19169931.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- II2022-10
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .