- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07568249
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment: A Prospective Study
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Artur Filipe Simões
- Telefonnummer: +351962555077
- E-Mail: filipesimoesmd@gmail.com
Studienorte
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Lisbon District
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Lisbon, Lisbon District, Portugal, 1070-061
- Rekrutierung
- Instituto de Implantologia
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Kontakt:
- Artur Simões
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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:
-
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Oral Quality of Life
Zeitfenster: From enrollment to the end of the treatment - final rehabilitation placed - 1 month after
|
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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- II2022-10
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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