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

Browse trials for

• Mouth, Edentulous 244
• Tooth Loss 222

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

Study population

Groups and cohorts

• 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

• ProcedureFull 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.

• DeviceFull 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, 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.

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 placeme

Secondary 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).

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/science/article/pii/S1646289014002039)
• 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. PubMed 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. PubMed 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. PubMed 9332805 ↗
• Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11. PubMed 8193981 ↗

Individual participant data

Plan to share: Undecided