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

NCT07568249 | Recruiting

• 1 other identifier: II2022-10
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Mouth; Quality of Life; Tooth Loss; Oral Health Quality of Life (OHQoL) Was Assessed

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

Outcome Measures

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: 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 Outcomes (2)

• 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).

• 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).

Study Arms (1)

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

Procedure: Full Arch Implant Surgery; Device: Full arch prosthesis

Interventions

Full Arch Implant Surgery PROCEDURE

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.

Full-Arch Immediate Implant-Supported Rehabilitation

Full arch prosthesis DEVICE

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.

Full-Arch Immediate Implant-Supported Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Implantology Institute: lead

Study Sites (1)

Instituto de Implantologia

Lisbon, Lisbon District, 1070-061, Portugal

RECRUITING

Related Publications (5)

• 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)

  BACKGROUND

• 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.

  PMID: 20685078 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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

  PMID: 8193981 BACKGROUND

MeSH Terms

Conditions

Mouth, Edentulous; Tooth Loss

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Periodontal Diseases

Study Officials

• Artur F Simões, Msc

  Implantology Institute

  PRINCIPAL INVESTIGATOR

• Duarte Marques, Phd

  Implantology Institute

  STUDY DIRECTOR

Central Study Contacts

Artur F Simões

CONTACT

+351962555077; filipesimoesmd@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

PT (1)