Peri-implantitisNCT07391202
Crown Removal in Non-Surgical Peri-Implantitis Therapy: A Randomized Trial
A study testing Non-Surgical Peri-Implant Therapy without Crown and Non-Surgical Peri-Implant Therapy with Crown in people with Peri-implantitis, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
The aim of this single-blind, randomized controlled clinical trial is to evaluate whether removal of the prosthetic crown influences the clinical effectiveness of non-surgical mechanical therapy in implants affected by peri-implantitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Non-Surgical Peri-Implant Therapy without Crown and Non-Surgical Peri-Implant Therapy with Crown
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2026to 31 Jul 2027
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with at least one implant diagnosed with peri-implantitis (Berglundh et al., 2018);
- Patients with a crown on the implant affected by peri-implantitis that is removable;
- Patients who have not received non-surgical peri-implant therapy in the previous 6 months;
- Patients who have not taken systemic antibiotic therapy in the previous 3 months.
Who cannot join
- Full-Mouth Plaque Score (FMPS) > 30% at the time of non-surgical therapy;
- Pregnant or breastfeeding women;
- Relevant medical history, in the opinion of the examining clinician, that could affect the outcome of non-surgical peri-implant therapy;
- Smoking patients consuming > 10 cigarettes/day.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Dental Clinic, Department of Innovative Technologies in Medicine and Dentistry, 'G. D'Annunzio' University of Chieti-Pescara
Chieti, Chieti, 66100
Matteo Serroni, DDS, 08713554158, serronimatteo@gmail.com
About this study
Official title: Effectiveness of Non-Surgical Mechanical Therapy of Peri-Implantitis With or Without Prosthetic Crown Removal: A Randomized Controlled Trial
The aim of this single-blind, randomized controlled clinical trial is to evaluate whether removal of the prosthetic crown influences the clinical effectiveness of non-surgical mechanical therapy in implants affected by peri-implantitis.
The study is designed to compare changes in several clinical and radiographic parameters between baseline and follow-up examinations at 3, 6, and 12 months. The primary outcome measure will be the mean peri-implant probing depth (PIPD). Secondary outcomes will include changes in gingival recession (REC), radiographic marginal bone level (MBL), modified bleeding index (mBI), and additional patient-related variables.
- Conditions
- Peri-implantitis
- Being tested
- Non-Surgical Peri-Implant Therapy without Crown, Non-Surgical Peri-Implant Therapy with Crown
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Peri-Implant Therapy without CrownProcedure or surgery
In this group, the prosthetic crown will be temporarily removed before treatment to allow direct and complete access to the peri-implant tissues and implant surface. After local anesthesia, a thorough mechanical debridement will be performed up to the bottom of the peri-implant pocket using sonic scalers, piezoelectric/ultrasonic devices with dedicated thin tips, and Gracey curettes. The absence of the crown enables improved visualization, more effective instrumentation, and more accurate disruption of the submucosal biofilm. At the end of the procedure, the prosthetic crown will be repositioned. Standardized oral hygiene instructions and motivation will be provided. This intervention aims to maximize cleaning efficacy by eliminating prosthetic-related access limitations.
Non-Surgical Peri-Implant Therapy with CrownProcedure or surgery
In this group, non-surgical mechanical therapy will be carried out with the prosthetic crown left in place. After local anesthesia, debridement of the peri-implant pocket will be performed using the same instruments and protocol as in the test group, including sonic scalers, ultrasonic devices with thin tips, and Gracey curettes. The presence of the crown limits access to some peri-implant areas and reflects routine clinical practice. Patients will receive standardized oral hygiene instructions and reinforcement. This intervention represents the conventional non-surgical management of peri-implantitis without removal of the restoration
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical therapy with prosthetic crown removal | Experimental | Implants allocated to this group will receive non-surgical peri-implant therapy after temporary removal of the prosthetic crown. The crown will be unscrewed before treatment to allow direct access and full visibility of the implant surface and peri-implant tissues. Mechanical debridement will then be performed under local anesthesia using sonic and ultrasonic devices with dedicated thin tips and Gracey curettes, according to the EFP S3-level clinical practice guidelines. After completion of debridement and biofilm removal, the prosthetic crown will be reinstalled. Patients will receive oral hygiene instructions and reinforcement. Receives: Procedure: Non-Surgical Peri-Implant Therapy without Crown |
| Non-surgical therapy without prosthetic crown removal | Active comparator | Implants allocated to this group will receive non-surgical peri-implant therapy with the prosthetic crown left in place. Mechanical debridement will be performed under local anesthesia using the same instruments and protocol as in the test group (sonic scaler, ultrasonic devices, and Gracey curettes), but with access limited by the presence of the restoration. Professional oral hygiene instructions and reinforcement will also be provided. Receives: Procedure: Non-Surgical Peri-Implant Therapy with Crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant probing depth (PIPD)
Change in mean peri-implant probing depth (PIPD) at the implant level (measured at 6 sites per implant) from baseline to 3, 6, and 12 months after crown removal.
Measured: From enrollment to the end of treatment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start20 Apr 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Paolantonio, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391202
- Sponsor's protocol ID
- 29012026
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 7 May 2026
- Results posted
- No
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-Surgical Mechanical Therapy of Peri-Implantitis With or Without Prosthetic Crown Removal: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07391202
- Acronym / sponsor ID
- 29012026
- Conditions
- Peri-implantitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 5 Feb 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 aim of this single-blind, randomized controlled clinical trial is to evaluate whether removal of the prosthetic crown influences the clinical effectiveness of non-surgical mechanical therapy in implants affected by peri-implantitis.
The study is designed to compare changes in several clinical and radiographic parameters between baseline and follow-up examinations at 3, 6, and 12 months. The primary outcome measure will be the mean peri-implant probing depth (PIPD). Secondary outcomes will include changes in gingival recession (REC), radiographic marginal bone level (MBL), modified bleeding index (mBI), and additional patient-related variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-surgical therapy with prosthetic crown removal | Experimental | Procedure: Non-Surgical Peri-Implant Therapy without CrownImplants allocated to this group will receive non-surgical peri-implant therapy after temporary removal of the prosthetic crown. The crown will be unscrewed before treatment to allow direct access and full visibility of the implant surface and peri-implant tissues. Mechanical debridement will then be performed under local anesthesia using sonic and ultrasonic devices with dedicated thin tips and Gracey curettes, according to the EFP S3-level clinical practice guidelines. After completion of debridement and biofilm removal, the prosthetic crown will be reinstalled. Patients will receive oral hygiene instructions and reinforcement. |
| Non-surgical therapy without prosthetic crown removal | Active comparator | Procedure: Non-Surgical Peri-Implant Therapy with CrownImplants allocated to this group will receive non-surgical peri-implant therapy with the prosthetic crown left in place. Mechanical debridement will be performed under local anesthesia using the same instruments and protocol as in the test group (sonic scaler, ultrasonic devices, and Gracey curettes), but with access limited by the presence of the restoration. Professional oral hygiene instructions and reinforcement will also be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with at least one implant diagnosed with peri-implantitis (Berglundh et al., 2018);
- Patients with a crown on the implant affected by peri-implantitis that is removable;
- Patients who have not received non-surgical peri-implant therapy in the previous 6 months;
- Patients who have not taken systemic antibiotic therapy in the previous 3 months.
Key exclusion criteria (4 listed)
- Full-Mouth Plaque Score (FMPS) > 30% at the time of non-surgical therapy;
- Pregnant or breastfeeding women;
- Relevant medical history, in the opinion of the examining clinician, that could affect the outcome of non-surgical peri-implant therapy;
- Smoking patients consuming > 10 cigarettes/day.
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 |
|---|---|---|
| Non-Surgical Peri-Implant Therapy without CrownIn this group, the prosthetic crown will be temporarily removed before treatment to allow direct and complete access to the peri-implant tissues and implant surface. After local anesthesia, a thorough mechanical debridement will be performed up to the bottom of the peri-implant pocket using sonic scalers, piezoelectric/ultrasonic devices with dedicated thin tips, and Gracey curettes. The absence of the crown enables improved visualization, more effective instrumentation, and more accurate disruption of the submucosal biofilm. At the end of the procedure, the prosthetic crown will be repositioned. Standardized oral hygiene instructions and motivation will be provided. This intervention aims to maximize cleaning efficacy by eliminating prosthetic-related access limitations. | Procedure or surgery | Non-surgical therapy with prosthetic crown removal |
| Non-Surgical Peri-Implant Therapy with CrownIn this group, non-surgical mechanical therapy will be carried out with the prosthetic crown left in place. After local anesthesia, debridement of the peri-implant pocket will be performed using the same instruments and protocol as in the test group, including sonic scalers, ultrasonic devices with thin tips, and Gracey curettes. The presence of the crown limits access to some peri-implant areas and reflects routine clinical practice. Patients will receive standardized oral hygiene instructions and reinforcement. This intervention represents the conventional non-surgical management of peri-implantitis without removal of the restoration | Procedure or surgery | Non-surgical therapy without prosthetic crown removal |
Primary outcome
Peri-implant probing depth (PIPD)
Time frame: From enrollment to the end of treatment at 1 year
Change in mean peri-implant probing depth (PIPD) at the implant level (measured at 6 sites per implant) from baseline to 3, 6, and 12 months after crown removal.
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 7 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Peri-Implant Therapy without Crown and Non-Surgical Peri-Implant Therapy with Crown in people with Peri-implantitis, run by G. d'Annunzio University 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 4 inclusion and 4 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 7 May 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?
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 Michele Paolantonio, DDS, MD (+3908713554158, michelapolantonio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant probing depth (PIPD) (time frame: From enrollment to the end of treatment at 1 year). 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 7 May 2026.