Peri ImplantitisPeriimpMAANCT07191522
Efficacy of Photodynamic Therapy in the Non-Surgical Treatment of Peri-Implantitis
A study testing Mechanical debridment with titanium curettes and ultrasounds and Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy) in people with Peri Implantitis, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial summary
Peri-implantitis is a growing public health problem that can lead to several complications and sequelae, with a serious impact on the health and quality of life of patients and a high cost for healthcare systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri Implantitis
- What is being tested?
- Mechanical debridment with titanium curettes and ultrasounds and Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 14 May 2025to 30 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years of age;
- patients with one or more implants diagnosed with peri-implantitis rehabilitated for at least one year;
- PI and GI < 25%.
Who cannot join
- smoking patients;
- patients with uncontrolled periodontitis;
- systemic diseases that influence the study (diabetes);
- inadequate prosthetic rehabilitation that cannot be modified or that prevents access for physical decontamination;
- implants rehabilitated with cemented crowns;
- pregnant and lactating women;
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- previous surgical intervention at the same site;
- therapy with non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics or immunosuppressants in the last 3 months;
- patients previously undergoing chemotherapy or radiotherapy;
- PI and IG > 25%;
- uncooperative patients.
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
Egas Moniz School of Health and Science
Almada, Monte Da Caparica, 2829-511
Inês Gomes, PhD, 212946748 ext. 00351, rso.ciiem@egasmonizpt.onmicrosoft.com
Mariana Assunção, Master, 919970304 ext. 00351, massuncao@egasmoniz.edu.pt
About this study
Peri-implantitis is a growing public health problem that can lead to several complications and sequelae, with a serious impact on the health and quality of life of patients and a high cost for healthcare systems.
Bacterial plaque that accumulates around dental implants leads to peri-implant tissue inflammation that ultimately can result in the loss of the implant, significant bone destruction and infection that can reach other regions. Successful implant decontamination is necessary to preserve the implant and several strategies have been suggested for this purpose, however, there is still no fully effective treatment modality and failures and recurrence are relatively frequent.
To better understand this problem and develop more effective treatment strategies, investigators will first conduct an epidemiological study to understand the factors associated with the development of this pathology. Although there is data at an international level, the incidence of this problem in Portugal has not yet been properly studied. Later investigators will conduct a randomized clinical trial to evaluate the 6-week clinical outcomes of patients treated with a photodynamic therapy as an adjuvant versus the use of conventional titanium implant curettes for implant surface decontamination in the non-surgical treatment. Sixty patients/implants with peri-implantitis and within the established criteria, will undergo non-surgical treatment with one of the two protocols being studied. Various clinical and radiographic parameters will be evaluated, such as probing depth, insertion loss, recession, bleeding on probing, suppuration, peri-implant crevicular fluid volume, alveolar bone loss and peri-implantitis microbiome will be evaluated before surgery and 6 weeks after surgery.
- Conditions
- Peri Implantitis
- Being tested
- Mechanical debridment with titanium curettes and ultrasounds, Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy)
- Keywords
- Peri-implantitis, Antimicrobial Photodynamic Therapy
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical debridment with titanium curettes and ultrasoundsProcedure or surgery
Removal of deposits above and below the gum line using hand or ultrasonic tools to reduce the inflammatory parameters
Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy)Procedure or surgery
Non-invasive treatment that uses a combination of a light-sensitive compound (photosensitizer), specific light and oxygen to generate reactive oxygen species (ROS) that kill bacteria
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Mechanical debridment with titanium curettes and ultrasounds Receives: Procedure: Mechanical debridment with titanium curettes and ultrasounds |
| Study Group | Experimental | Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy) Receives: Procedure: Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
Measuring in milimeters the distance from the gingival margin to the base of a sulcus or peri-implant pocket, using a periodontal probe.
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (5)
Clinical attachment level
Measured with a periodontal probe as the distance from a fixed reference point (usually the implant shoulder or gingival margin) to the base of the peri-implant pocket.
Measured: From enrollment to the end of treatment at 3 months.
Bleeding on Probing
Assessed during gentle probing; bleeding indicates a positive site.
Measured: From enrollment to the end of treatment at 3 months.
Suppuration
Detected by probing or gentle pressure, with purulent exudate confirming presence.
Measured: From enrollment to the end of treatment at 3 months.
Radiographic bone level
Assessed on standardized periapical radiographs, measuring the distance from a fixed reference point (implant shoulder or platform) to the most coronal bone-to-implant contact.
Measured: From enrollment to the end of treatment at 3 months.
Microbiology outcome
Changes in the microbiome collected from peri-implant pockets sequencing 16S ribosomal RNA gene
Measured: From enrollment to the end of treatment at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start14 May 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Alves, PhD, Principal investigator, Egas Moniz School of Health and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191522
- Sponsor's protocol ID
- aPDT MAA
- Other IDs
- Research Grant
- Acronym
- PeriimpMAA
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 25 Sep 2025
- 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Photodynamic Therapy in the Non-Surgical Treatment of Peri-Implantitis
- ClinicalTrials.gov ID
- NCT07191522
- Acronym / sponsor ID
- PeriimpMAA / aPDT MAA
- Conditions
- Peri Implantitis
- Keywords
- Peri-implantitis, Antimicrobial Photodynamic Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 25 Sep 2025 (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.
Peri-implantitis is a growing public health problem that can lead to several complications and sequelae, with a serious impact on the health and quality of life of patients and a high cost for healthcare systems.
Bacterial plaque that accumulates around dental implants leads to peri-implant tissue inflammation that ultimately can result in the loss of the implant, significant bone destruction and infection that can reach other regions. Successful implant decontamination is necessary to preserve the implant and several strategies have been suggested for this purpose, however, there is still no fully effective treatment modality and failures and recurrence are relatively frequent.
To better understand this problem and develop more effective treatment strategies, investigators will first conduct an epidemiological study to understand the factors associated with the development of this pathology. Although there is data at an international level, the incidence of this problem in Portugal has not yet been properly studied. Later investigators will conduct a randomized clinical trial to evaluate the 6-week clinical outcomes of patients treated with a photodynamic therapy as an adjuvant versus the use of conventional titanium implant curettes for implant surface decontamination in the non-surgical treatment. Sixty patients/implants with peri-implantitis and within the established criteria, will undergo non-surgical treatment with one of the two protocols being studied. Various clinical and radiographic parameters will be evaluated, such as probing depth, insertion loss, recession, bleeding on probing, suppuration, peri-implant crevicular fluid volume, alveolar bone loss and peri-implantitis microbiome will be evaluated before surgery and 6 weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Mechanical debridment with titanium curettes and ultrasoundsMechanical debridment with titanium curettes and ultrasounds |
| Study Group | Experimental | Procedure: Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy)Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients over 18 years of age;
- patients with one or more implants diagnosed with peri-implantitis rehabilitated for at least one year;
- PI and GI < 25%.
Key exclusion criteria (11 listed)
- smoking patients;
- patients with uncontrolled periodontitis;
- systemic diseases that influence the study (diabetes);
- inadequate prosthetic rehabilitation that cannot be modified or that prevents access for physical decontamination;
- implants rehabilitated with cemented crowns;
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 |
|---|---|---|
| Mechanical debridment with titanium curettes and ultrasoundsRemoval of deposits above and below the gum line using hand or ultrasonic tools to reduce the inflammatory parameters | Procedure or surgery | Control Group |
| Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy)Non-invasive treatment that uses a combination of a light-sensitive compound (photosensitizer), specific light and oxygen to generate reactive oxygen species (ROS) that kill bacteria | Procedure or surgery | Study Group |
Primary outcome
Probing Depth
Time frame: From enrollment to the end of treatment at 3 months
Measuring in milimeters the distance from the gingival margin to the base of a sulcus or peri-implant pocket, using a periodontal probe.
5 secondary outcomes
Clinical attachment level
Time frame: From enrollment to the end of treatment at 3 months.
Bleeding on Probing
Time frame: From enrollment to the end of treatment at 3 months.
Suppuration
Time frame: From enrollment to the end of treatment at 3 months.
Radiographic bone level
Time frame: From enrollment to the end of treatment at 3 months.
Microbiology outcome
Time frame: From enrollment to the end of treatment at 3 months.
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 25 Sep 2025.
- LED websiteLink provided by the sponsor.
- 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.
Ricardo Alves, PhD principal investigator
Egas Moniz School of Health and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical debridment with titanium curettes and ultrasounds and Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy) in people with Peri Implantitis, run by Egas Moniz - Cooperativa de Ensino Superior, CRL 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 11 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 25 Sep 2025. 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 Mariana A Assunção, Master (+351919970304 ext. 00351, massuncao@egasmoniz.edu.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Depth (time frame: From enrollment to the end of treatment at 3 months). 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 25 Sep 2025.