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

Official title

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

Overview

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

• 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, allowi

Primary outcome measures

• Change in Oral Health-Related Quality of Life measured by the Oral Health Impact Profile-14 Portuguese version [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 placeme]

Secondary outcome measures (2)

• Change in psychosocial impact of dental aesthetics measured by the Psychosocial Impact of Dental Aesthetics Questionnaire - Portuguese version (PIDAQ-PT) [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).]
• Patient satisfaction measured by a Global Satisfaction Questionnaire [Time frame: T0 - baseline before surgery; T4 - 1 month after definitive prosthesis placement (approximately 4 to 7 months from baseline).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Portugal · 1 center

• Instituto de Implantologia — Lisbon

Publications

• 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/sci
• 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- PMID 20685078
• 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. PMID 36011570
• 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. PMID 9332805
• Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11. PMID 8193981

Identifiers

NCT: NCT07568249 · II2022-10

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗