Edentulous MouthNCT07568249
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
An observational study of Edentulous Mouth and Quality of Life, run by Implantology Institute at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Mouth, Quality of Life, Tooth Loss
- What is being tested?
- Full Arch Implant Surgery and Full arch prosthesis
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Nov 2025to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Instituto de Implantologia
Lisbon, Lisbon District, 1070-061
Artur F Simões
Artur F Simões, Msc
About this study
Official title: Changes in Oral Health-related Quality of Life ( OHRQoL) Full Arch Implant Treatment: A Prospective Study
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.
Read the 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.
- Conditions
- Edentulous Mouth, Quality of Life, Tooth Loss, Oral Health Quality of Life (OHQoL) Was Assessed
- Being tested
- Full Arch Implant Surgery, Full arch prosthesis
- 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
- Medical subject headings
- Mouth, Edentulous, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Arch Implant SurgeryProcedure or 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.
Full arch prosthesisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Full Arch Implant Surgery; Device: Full arch prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [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)
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.
Measured: 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
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.
Measured: T0 - baseline before surgery; T4 - 1 month after definitive prosthesis placement (approximately 4 to 7 months from baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 Nov 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Edentulous MouthStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Artur F Simões, Msc, Principal investigator, Implantology InstituteDuarte Marques, Phd, Study director, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568249
- Sponsor's protocol ID
- II2025-01
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 20685078Fidalgo 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 36011570Slade 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 9332805Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
PubMed 8193981
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Oral Health-related Quality of Life ( OHRQoL) Full Arch Implant Treatment: A Prospective Study
- ClinicalTrials.gov ID
- NCT07568249
- Acronym / sponsor ID
- II2025-01
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 5 May 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full-Arch Immediate Implant-Supported Rehabilitation | – | Procedure: Full Arch Implant Surgery, Device: Full arch prosthesisParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Arch Implant SurgeryA 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. | Procedure or surgery | Full-Arch Immediate Implant-Supported Rehabilitation |
| Full arch prosthesisThis 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. | Device | Full-Arch Immediate Implant-Supported Rehabilitation |
Primary outcome
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
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.
2 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- BackgroundJoão 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: PubMed 20685078Cella 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.
- Background: PubMed 36011570Fidalgo 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.
- Background: PubMed 9332805Slade 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.
- Background: PubMed 8193981Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
- Individual participant dataSharing planned: Undecided
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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.
Artur F Simões, Msc principal investigator
Implantology Institute
Duarte Marques, Phd study director
Implantology Institute
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 Edentulous Mouth and Quality of Life, run by Implantology Institute at 1 site in Portugal.
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 2 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: looking for participants now, as of the sponsor's last update on 27 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Artur F Simões (+351962555077, filipesimoesmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07568249, which also lists 5 linked publications.
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 27 Oct 2026.