Quality of Life, Nutritional Status and Aesthetics in Patients Rehabilitated With FP1 Full-Arch Reconstructions

NCT07892014 | Completed DMC

• 1 other identifier: 0034197
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The World Health Organization defines quality of life as "a state of physical, mental, and social well-being"; therefore, it is important to consider the patient holistically, taking into account social function and the ability to meet basic needs, such as the ability to eat and pain control. In this context, oral health plays a key role in patient well-being, as it is essential for communication, chewing, nutrition, and aesthetics. The loss of teeth-whether extracted due to periodontal disease or caries-can cause masticatory, phonetic, and aesthetic impairments, which are considered factors contributing to a decline in quality of life. The loss of natural teeth compromises masticatory function, making appropriate prosthetic rehabilitation essential to restore oral function and improve quality of life.

Conditions

Edentulism Complete; Dental Implant

Keywords

Quality of life; Nutritional status; FP1 Prosthesis; Edentulism

Outcome Measures

Primary Outcomes (1)

• Oral Health Impact Profile - 14

  Quality of oral health percepition by patient

  within 24 hours prior to the implant-prosthetic surgery (T0); on the day of the surgery, following the placement of the implants and the provisional prosthesis (T1); 3 months post-surgery (T2); 3 months after the delivery of the definitive prosthesis (T3

Secondary Outcomes (3)

• Nutritional Status

  within 24 hours prior to the implant-prosthetic surgery (T0); on the day of the surgery, following the placement of the implants and the provisional prosthesis (T1); 3 months post-surgery (T2); 3 months after the delivery of the definitive prosthesis (T3

• Quality of nutrition

  within 24 hours prior to the implant-prosthetic surgery (T0); on the day of the surgery, following the placement of the implants and the provisional prosthesis (T1); 3 months post-surgery (T2); 3 months after the delivery of the definitive prosthesis (T3

• Pink Esthetic Score

  within 24 hours prior to the implant-prosthetic surgery (T0); on the day of the surgery, following the placement of the implants and the provisional prosthesis (T1); 3 months post-surgery (T2); 3 months after the delivery of the definitive prosthesis (T3

Study Arms (1)

Edentulous patients requiring full-arch rehabilitation

Edentulous patients requiring full-arch rehabilitation. The patients are candidates for FP1-type implant-supported rehabilitation. Data regarding quality of life, nutritional status, and aesthetic quality are collected at the preoperative stage, during the prosthetic rehabilitation phases, and after completion of the prosthesis.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in good health with an edentulous arch requiring full-arch implant rehabilitation.

You may qualify if:

• Patients in good health;
• Patients requiring full-arch implant-prosthetic rehabilitation;
• Patients who agree to the study protocol by signing the informed consent form.

You may not qualify if:

• Patients with contraindications to implant rehabilitation;
• Patients with a specific dietary regimen (e.g., vegetarian diet);
• Patients with depression and social anxiety.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

AOU Città della Salute e della Scienza

Torino, Italy, 10126, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dental Hygienist

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 23, 2026
• Study Start: January 7, 2025
• Primary Completion: April 30, 2026
• Study Completion: September 15, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-03

Locations

IT (1)