Trials / Recruiting
RecruitingNCT07191522
Efficacy of Photodynamic Therapy in the Non-Surgical Treatment of Peri-Implantitis
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Mechanical debridment with titanium curettes and ultrasounds | Removal of deposits above and below the gum line using hand or ultrasonic tools to reduce the inflammatory parameters |
| PROCEDURE | 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 |
Timeline
- Start date
- 2025-05-14
- Primary completion
- 2026-07-30
- Completion
- 2027-07-30
- First posted
- 2025-09-25
- Last updated
- 2025-09-25
Locations
1 site across 1 country: Portugal
Source: ClinicalTrials.gov record NCT07191522. Inclusion in this directory is not an endorsement.