Edentulism CompleteNCT07892014
Quality of Life, Nutritional Status and Aesthetics in Patients Rehabilitated With FP1 Full-Arch Reconstructions
An observational study of Edentulism Complete and Dental Implant, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Edentulism Complete, Dental Implant
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2025to 15 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in good health with an edentulous arch requiring full-arch implant rehabilitation.
Who may be able to join
- Patients in good health;
- Patients requiring full-arch implant-prosthetic rehabilitation;
- Patients who agree to the study protocol by signing the informed consent form.
Who cannot join
- Patients with contraindications to implant rehabilitation;
- Patients with a specific dietary regimen (e.g., vegetarian diet);
- Patients with depression and social anxiety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Perceived Oral Health and Dietary Changes in Patients Rehabilitated With Full-arch Immediate-loading Implants.
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.
Read more
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health Impact Profile - 14
Quality of oral health percepition by patient
Measured: 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
Percentages regarding the consistency of consumed foods.
Measured: 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
Percentages regarding the quality of food consumed.
Measured: 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
Index regarding the aesthetics of the implant-supported prosthesis in relation to the soft tissues adjacent to the restoration
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start7 Jan 2025
- Primary completion30 Apr 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulism CompleteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacopo Lanzetti, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892014
- Sponsor's protocol ID
- 0034197
- Status last verified
- Mar 2026
- First submitted
- 9 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Perceived Oral Health and Dietary Changes in Patients Rehabilitated With Full-arch Immediate-loading Implants.
- ClinicalTrials.gov ID
- NCT07892014
- Acronym / sponsor ID
- 0034197
- Conditions
- Edentulism Complete, Dental Implant
- Keywords
- Quality of life, Nutritional status, FP1 Prosthesis, Edentulism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in good health with an edentulous arch requiring full-arch implant rehabilitation.
Key inclusion criteria (3 listed)
- Patients in good health;
- Patients requiring full-arch implant-prosthetic rehabilitation;
- Patients who agree to the study protocol by signing the informed consent form.
Key exclusion criteria (3 listed)
- Patients with contraindications to implant rehabilitation;
- Patients with a specific dietary regimen (e.g., vegetarian diet);
- Patients with depression and social anxiety.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral Health Impact Profile - 14
Time frame: 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 oral health percepition by patient
3 secondary outcomes
Nutritional Status
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Edentulism Complete
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Recruiting
Accuracy of Complete-Arch Implant Scans Using Non Calibrated Splinting Scanbodies
Edentulism Complete
Active, not recruiting
Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis.
Complete Edentulism
Not yet recruiting
Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures
Edentulism
Recruiting
Nutritional Intervention for Older Adults With Complete Dentures
Edentulism Complete, Denture, Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulism Complete and Dental Implant, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Health Impact Profile - 14 (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.