Patients Requiring an Implant-supported RehabilitationNCT07332195
Implant Rehabilitations in a Hospital Setting
An observational study of Patients Requiring an Implant-supported Rehabilitation and Edentulous Patients Requiring an Implant-supported Rehabilitation, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Dental implants are considered a predictable rehabilitation option for tooth extraction or missing teeth. The use of dental implants has evolved into a viable prosthetic alternative to conventional tooth-supported fixed prostheses or removable dentures, with advantages in terms of patient satisfaction and quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Requiring an Implant-supported Rehabilitation, Edentulous Patients Requiring an Implant-supported Rehabilitation
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Dec 2030
- 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: Patients aged >18 years who require implant-supported rehabilitation
Who may be able to join
- Patients requiring implant surgery for edentulous rehabilitation;
- Age > 18;
- Achievement of FMPS and FMBS ≤ 15%;
- Signed written informed consent to participate in the study.
Who cannot join
- Uncontrolled diabetes or hypertension;
- Uncontrolled periodontal disease;
- Inability to perform consistent and continuous follow-up;
- Pregnancy or breastfeeding;
- Inability to provide written informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Radiographic Analysis of Implant Rehabilitations in a Hospital Setting: a Prospective Study
Dental implants are considered a predictable rehabilitation option for tooth extraction or missing teeth. The use of dental implants has evolved into a viable prosthetic alternative to conventional tooth-supported fixed prostheses or removable dentures, with advantages in terms of patient satisfaction and quality of life. Long-term studies have reported excellent success and survival rates for implants used in prosthetic rehabilitation. Benefits in terms of patient satisfaction and preservation of adjacent tooth structure are among the advantages of implant-supported restorations over prosthetic alternatives. However, dental implants can be subject to mechanical and biological complications. After the first year of function, marginal bone loss is minimal around most oral implants. Nevertheless, marginal bone loss or the onset of bacterial-related biological complications, such as mucositis and peri-implantitis, can occur. Despite the growing number of publications in the field of implant rehabilitation, to date only a few studies have investigated the outcomes of implant rehabilitation in a hospital setting characterized by patients with concomitant or previous systemic therapies and pathologies. The objective of this study is to evaluate the success of implant therapy, peri-implant marginal bone resorption (MBL), clinical parameters of peri-implant health, aesthetic parameters of rehabilitation, and patient-reported treatment outcomes in a sample of patients treated in a hospital setting.
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 |
|---|---|---|
| Implant-supported rehabilitation | Patients aged >18 years who require implant-supported rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant marginal bone loss
Measurements were performed in millimeters using intraoral radiographs.
Measured: From Implant placement to 5 year follow up.
Implant survival rate
Rate of dental implants remaining in situ, measured as a proportion.
Measured: From Implant placement to 5 year follow up.
Secondary outcomes (12)
Implant success rate
Absence of biological and technical complications, expressed as a proportion.
Measured: From Implant placement to 5 year follow up.
Prosthesis survival rate
Rate of prostheses remaining in situ, expressed as a proportion.
Measured: From Implant placement to 5 year follow up.
Prosthesis success rate
Absence of technical complications, expressed as a proportion.
Measured: From Implant placement to 5 year follow up.
Esthetic evaluation
Assessed using the PES/WES esthetic index. Scores range from 0 to 14 for the PES and from 0 to 10 for the WES, with higher scores indicating better esthetic outcomes.
Measured: From Implant placement to 5 year follow up.
Patient-Reported Outcome Measures
Recorded using a specifically designed questionnaire and measured with a visual analogue scale (VAS) ranging from 0 to 10, with higher scores indicating better outcomes.
Measured: From Implant placement to 5 year follow up.
Volumetric analysis
Assessed by superimposing the baseline volume with the volume recorded during follow-up using intraoral scans, measured in cubic millimeters.
Measured: From Implant placement to 5 year follow up.
Glycated hemoglobin level
Analysis of glycated hemoglobin levels recorded at baseline and during follow-up.
Measured: From Implant placement to 5 year follow up.
Diabetes
Analysis of the influence of diabetes during follow-up.
Measured: From Implant placement to 5 year follow up.
Influence of medications relevant to bone/tissue metabolism
Analysis of the influence of medications relevant to bone and tissue metabolism.
Measured: From Implant placement to 5 year follow up.
Osteoporosis
Analysis of influence of osteoporosis.
Measured: From Implant placement to 5 year follow up.
Cardiovascular disease
Analysis of influence of cardiovascuar disease.
Measured: From Implant placement to 5 year follow up.
Complete Blood Count
Analysis of the influence of complete blood count parameters.
Measured: From Implant placement to 5 year follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Patients Requiring an Implant-supported RehabilitationStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Lajolo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332195
- Sponsor's protocol ID
- ID 7698
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217.
PubMed 19885446Gelb DA. Immediate implant surgery: three-year retrospective evaluation of 50 consecutive cases. Int J Oral Maxillofac Implants. 1993;8(4):388-99.
PubMed 8270307Nir-Hadar O, Palmer M, Soskolne WA. Delayed immediate implants: alveolar bone changes during the healing period. Clin Oral Implants Res. 1998 Feb;9(1):26-33. doi: 10.1034/j.1600-0501.1998.090104.x.
PubMed 9590942Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4.
PubMed 68096633) Branemark PI. Introduction to osseointegration. In: BranemarkPI, Zarb GA, Albrektsson T, Rosen HM, eds. Tissue-IntegratedProstheses: Osseointegration in Clinical Dentistry. Chicago:Quintessence Publishing Company, Inc; 1985:11-76.
den Hartog L, Slater JJ, Vissink A, Meijer HJ, Raghoebar GM. Treatment outcome of immediate, early and conventional single-tooth implants in the aesthetic zone: a systematic review to survival, bone level, soft-tissue, aesthetics and patient satisfaction. J Clin Periodontol. 2008 Dec;35(12):1073-86. doi: 10.1111/j.1600-051X.2008.01330.x.
PubMed 19040585Siadat H, Alikhasi M, Beyabanaki E. Interim Prosthesis Options for Dental Implants. J Prosthodont. 2017 Jun;26(4):331-338. doi: 10.1111/jopr.12421. Epub 2016 Jan 24.
PubMed 26805651
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Analysis of Implant Rehabilitations in a Hospital Setting: a Prospective Study
- ClinicalTrials.gov ID
- NCT07332195
- Acronym / sponsor ID
- ID 7698
- Conditions
- Patients Requiring an Implant-supported Rehabilitation, Edentulous Patients Requiring an Implant-supported Rehabilitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 12 Jan 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.
Dental implants are considered a predictable rehabilitation option for tooth extraction or missing teeth. The use of dental implants has evolved into a viable prosthetic alternative to conventional tooth-supported fixed prostheses or removable dentures, with advantages in terms of patient satisfaction and quality of life. Long-term studies have reported excellent success and survival rates for implants used in prosthetic rehabilitation. Benefits in terms of patient satisfaction and preservation of adjacent tooth structure are among the advantages of implant-supported restorations over prosthetic alternatives. However, dental implants can be subject to mechanical and biological complications. After the first year of function, marginal bone loss is minimal around most oral implants. Nevertheless, marginal bone loss or the onset of bacterial-related biological complications, such as mucositis and peri-implantitis, can occur. Despite the growing number of publications in the field of implant rehabilitation, to date only a few studies have investigated the outcomes of implant rehabilitation in a hospital setting characterized by patients with concomitant or previous systemic therapies and pathologies. The objective of this study is to evaluate the success of implant therapy, peri-implant marginal bone resorption (MBL), clinical parameters of peri-implant health, aesthetic parameters of rehabilitation, and patient-reported treatment outcomes in a sample of patients treated in a hospital setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant-supported rehabilitation | – | –Patients aged >18 years who require implant-supported rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged >18 years who require implant-supported rehabilitation
Key inclusion criteria (4 listed)
- Patients requiring implant surgery for edentulous rehabilitation;
- Age > 18;
- Achievement of FMPS and FMBS ≤ 15%;
- Signed written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Uncontrolled diabetes or hypertension;
- Uncontrolled periodontal disease;
- Inability to perform consistent and continuous follow-up;
- Pregnancy or breastfeeding;
- Inability to provide written informed consent.
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
Peri-implant marginal bone loss
Time frame: From Implant placement to 5 year follow up.
Measurements were performed in millimeters using intraoral radiographs.
Implant survival rate
Time frame: From Implant placement to 5 year follow up.
Rate of dental implants remaining in situ, measured as a proportion.
12 secondary outcomes
Implant success rate
Time frame: From Implant placement to 5 year follow up.
Prosthesis survival rate
Time frame: From Implant placement to 5 year follow up.
Prosthesis success rate
Time frame: From Implant placement to 5 year follow up.
Esthetic evaluation
Time frame: From Implant placement to 5 year follow up.
Patient-Reported Outcome Measures
Time frame: From Implant placement to 5 year follow up.
Volumetric analysis
Time frame: From Implant placement to 5 year follow up.
Glycated hemoglobin level
Time frame: From Implant placement to 5 year follow up.
Diabetes
Time frame: From Implant placement to 5 year follow up.
Influence of medications relevant to bone/tissue metabolism
Time frame: From Implant placement to 5 year follow up.
Osteoporosis
Time frame: From Implant placement to 5 year follow up.
Cardiovascular disease
Time frame: From Implant placement to 5 year follow up.
Complete Blood Count
Time frame: From Implant placement to 5 year follow up.
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 6 Feb 2026.
- Background: PubMed 19885446Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217.
- Background: PubMed 8270307Gelb DA. Immediate implant surgery: three-year retrospective evaluation of 50 consecutive cases. Int J Oral Maxillofac Implants. 1993;8(4):388-99.
- Background: PubMed 9590942Nir-Hadar O, Palmer M, Soskolne WA. Delayed immediate implants: alveolar bone changes during the healing period. Clin Oral Implants Res. 1998 Feb;9(1):26-33. doi: 10.1034/j.1600-0501.1998.090104.x.
- Background: PubMed 6809663Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4.
- Background3) Branemark PI. Introduction to osseointegration. In: BranemarkPI, Zarb GA, Albrektsson T, Rosen HM, eds. Tissue-IntegratedProstheses: Osseointegration in Clinical Dentistry. Chicago:Quintessence Publishing Company, Inc; 1985:11-76.
- Background: PubMed 19040585den Hartog L, Slater JJ, Vissink A, Meijer HJ, Raghoebar GM. Treatment outcome of immediate, early and conventional single-tooth implants in the aesthetic zone: a systematic review to survival, bone level, soft-tissue, aesthetics and patient satisfaction. J Clin Periodontol. 2008 Dec;35(12):1073-86. doi: 10.1111/j.1600-051X.2008.01330.x.
- Background: PubMed 26805651Siadat H, Alikhasi M, Beyabanaki E. Interim Prosthesis Options for Dental Implants. J Prosthodont. 2017 Jun;26(4):331-338. doi: 10.1111/jopr.12421. Epub 2016 Jan 24.
- Individual participant dataSharing planned: No
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.
Carlo Lajolo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Requiring an Implant-supported Rehabilitation and Edentulous Patients Requiring an Implant-supported Rehabilitation, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Carlo Lajolo, MD, DDS (+390630154286, carlo.lajolo@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant marginal bone loss (time frame: From Implant placement to 5 year follow up.). The study lists 2 primary outcomes in all. 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 NCT07332195, which also lists 7 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 6 Feb 2026.