Implant ComplicationIDRNCT06528587
Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants
An observational study of Implant Complication, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The scientific literature does not provide scientific evidence on how to manage patients suffering from monoedentulism with ridges having a reduced bone thickness or a reduced mesio-distal space. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Complication
- What is being tested?
- narrow diameter implant
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 15 Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged >18 years, in good general health, who have undergone implant rehabilitation of single edentulism in the anterior region will be selected.
Who may be able to join
- Patients who have undergone implant surgery to perform implant rehabilitation of single edentulism in the anterior region to insert a reduced diameter implant;
- ASA I and ASA II patients;
- Age > 18yr;
- Non-smokers or smokers ≤ 5 cig/day;
- Achievement of FMPS and FMBS ≤ 15%;
- Signing of the written informed consent to participate in the study.
Who cannot join
- Severe general medical pathologies;
- Immunodeficiency states;
- Radiotherapy in the head and neck region;
- Uncontrolled diabetes or hypertension;
- Smokers >5 cigs/day;
- Impossibility to carry out homogeneous and continuous follow-up;
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- Documented allergy to the biomaterials used;
- Pregnancy or breastfeeding;
- Inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Roma, 00168
About this study
Official title: Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants With Computer Guided Implant Insertion: a Prospective Study
The scientific literature does not provide scientific evidence on how to manage patients suffering from monoedentulism with ridges having a reduced bone thickness or a reduced mesio-distal space. Narrow diameter implants could be a solution to rehabilitate patients suffering from these clinical conditions while avoiding longer, more complex and sometimes even multidisciplinary therapies. However, there is a lack of clinical studies analyzing the outcomes of rehabilitation with narrow diameter implants.
Read the detailed description
Dental implants are considered a predictable rehabilitation option in the event of tooth extraction or missing tooth. In some cases, the inevitable resorption of the alveolar ridge after tooth extraction can make the insertion of dental implants difficult or even impossible without the use of more advanced bone regeneration procedures. Narrow diameter implants represent an alternative treatment option in areas with limited ridge width. Narrow alveolar ridges and limited interdental or inter-implant spaces continue to pose a challenge to the clinician. In the case of a narrow ridge, two options are available: the first option is to insert a standard diameter implant following bone augmentation procedures; the second option is to use an implant with a narrow diameter. Regarding the mesio-distal gap, an adequate distance between teeth and implants is necessary to reduce subsequent bone resorption and recession of the papillae. Difficult clinical situations with limited mesio-distal space or reduced ridge width can be overcome by using narrow diameter implants. Correct three-dimensional implant positioning is the key factor to obtain, in addition to good integration, favorable prosthetic results and a good long-term aesthetic result. To optimize the insertion of the implants, reducing the intrinsic imprecision of the conventional free-hand technique, computer-guided static surgery protocols can be used to plan the angulation, position and depth of the implant with a digital software. Narrow diameter implants therefore have their own indication for the replacement of lateral incisors of the maxilla and for the incisors of the mandible.
- Conditions
- Implant Complication
- Being tested
- narrow diameter implant
- Keywords
- narrow diameter implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
narrow diameter implantProcedure or surgery
Rehabilitation of single edentulism in the anterior region with narrow diameter implants and computer guided surgery.
| Study group | Role | What they receive |
|---|---|---|
| narrow diameter implant | Patients who have performed computer-guided implant surgery for the rehabilitation of single edentulism in the anterior region with lack of adequate bone thickness or mesio-distal space using implants with narrow diameter. Receives: Procedure: narrow diameter implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-implant marginal bone loss in millimeters
evaluation of the peri-implant marginal bone loss in millimeters
Measured: 12 months from implant placement
Secondary outcomes (4)
soft tissue evaluation in millimeters
evaluation of marginal soft tissues levels in millimeters
Measured: 12 months from implant placement
biological complication rate in percentage
evaluation of biological complications in percentage
Measured: 12 months from implant placement
esthetics
evaluation of the esthetics using the PES score
Measured: 12 months from implant placement
mechanical complication rate in percentage
evaluation of mechanical complications in percentage
Measured: 12 months from implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Sep 2024
- Primary completion15 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies 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
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Francesco Manicone, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528587
- Sponsor's protocol ID
- 6683
- Acronym
- IDR
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants With Computer Guided Implant Insertion: a Prospective Study
- ClinicalTrials.gov ID
- NCT06528587
- Acronym / sponsor ID
- IDR / 6683
- Conditions
- Implant Complication
- Keywords
- narrow diameter implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 30 Jul 2024 (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 scientific literature does not provide scientific evidence on how to manage patients suffering from monoedentulism with ridges having a reduced bone thickness or a reduced mesio-distal space. Narrow diameter implants could be a solution to rehabilitate patients suffering from these clinical conditions while avoiding longer, more complex and sometimes even multidisciplinary therapies. However, there is a lack of clinical studies analyzing the outcomes of rehabilitation with narrow diameter implants.
Detailed description
Dental implants are considered a predictable rehabilitation option in the event of tooth extraction or missing tooth. In some cases, the inevitable resorption of the alveolar ridge after tooth extraction can make the insertion of dental implants difficult or even impossible without the use of more advanced bone regeneration procedures. Narrow diameter implants represent an alternative treatment option in areas with limited ridge width. Narrow alveolar ridges and limited interdental or inter-implant spaces continue to pose a challenge to the clinician. In the case of a narrow ridge, two options are available: the first option is to insert a standard diameter implant following bone augmentation procedures; the second option is to use an implant with a narrow diameter. Regarding the mesio-distal gap, an adequate distance between teeth and implants is necessary to reduce subsequent bone resorption and recession of the papillae. Difficult clinical situations with limited mesio-distal space or reduced ridge width can be overcome by using narrow diameter implants. Correct three-dimensional implant positioning is the key factor to obtain, in addition to good integration, favorable prosthetic results and a good long-term aesthetic result. To optimize the insertion of the implants, reducing the intrinsic imprecision of the conventional free-hand technique, computer-guided static surgery protocols can be used to plan the angulation, position and depth of the implant with a digital software. Narrow diameter implants therefore have their own indication for the replacement of lateral incisors of the maxilla and for the incisors of the mandible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| narrow diameter implant | – | Procedure: narrow diameter implantPatients who have performed computer-guided implant surgery for the rehabilitation of single edentulism in the anterior region with lack of adequate bone thickness or mesio-distal space using implants with narrow diameter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged >18 years, in good general health, who have undergone implant rehabilitation of single edentulism in the anterior region will be selected.
Key inclusion criteria (6 listed)
- Patients who have undergone implant surgery to perform implant rehabilitation of single edentulism in the anterior region to insert a reduced diameter implant;
Key exclusion criteria (9 listed)
- Severe general medical pathologies;
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 |
|---|---|---|
| narrow diameter implantRehabilitation of single edentulism in the anterior region with narrow diameter implants and computer guided surgery. | Procedure or surgery | narrow diameter implant |
Primary outcome
peri-implant marginal bone loss in millimeters
Time frame: 12 months from implant placement
evaluation of the peri-implant marginal bone loss in millimeters
4 secondary outcomes
soft tissue evaluation in millimeters
Time frame: 12 months from implant placement
biological complication rate in percentage
Time frame: 12 months from implant placement
esthetics
Time frame: 12 months from implant placement
mechanical complication rate in percentage
Time frame: 12 months from implant placement
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Paolo Francesco Manicone principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Implant Complication, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 6 inclusion and 9 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 16 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?
peri-implant marginal bone loss in millimeters (time frame: 12 months from implant placement). 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 16 Oct 2026.