Peri Implantitis
Conditions
Keywords
Peri-implantitis, Antimicrobial Photodynamic Therapy
Brief 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.
Interventions
PROCEDUREMechanical 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
PROCEDUREMechanical 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
Sponsors
Egas Moniz - Cooperativa de Ensino Superior, CRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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%.
Exclusion criteria
* 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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing Depth | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level | From enrollment to the end of treatment at 3 months. | 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. |
| Bleeding on Probing | From enrollment to the end of treatment at 3 months. | Assessed during gentle probing; bleeding indicates a positive site. |
| Suppuration | From enrollment to the end of treatment at 3 months. | Detected by probing or gentle pressure, with purulent exudate confirming presence. |
| Radiographic bone level | From enrollment to the end of treatment at 3 months. | 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. |
| Microbiology outcome | From enrollment to the end of treatment at 3 months. | Changes in the microbiome collected from peri-implant pockets sequencing 16S ribosomal RNA gene |
Countries
Portugal
Contacts
Primary ContactMariana A Assunção, Master
Backup ContactInês Gomes, PhD
Outcome results
None listed