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| ID | Type | Description | Link |
|---|---|---|---|
| Research Grant | Other Identifier | Egas Moniz School of Health and Science |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Mechanical debridment with titanium curettes and ultrasounds |
|
| Study Group | Experimental | Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical debridment with titanium curettes and ultrasounds | Procedure | Removal of deposits above and below the gum line using hand or ultrasonic tools to reduce the inflammatory parameters |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 3 months. |
| Bleeding on Probing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariana A Assunção, Master | Contact | +351919970304 | 00351 | massuncao@egasmoniz.edu.pt |
| Inês Gomes, PhD | Contact | 212946748 | 00351 | inesgomes.ciiem@egasmoniz.edu.pt |
| Name | Affiliation | Role |
|---|---|---|
| Ricardo Alves, PhD | Egas Moniz School of Health and Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Egas Moniz School of Health and Science | Recruiting | Almada | Monte Da Caparica | 2829-511 | Portugal |
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| Label | URL |
|---|---|
| LED website | View source |
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| Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy) | Procedure | 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 |
|
Assessed during gentle probing; bleeding indicates a positive site. |
| From enrollment to the end of treatment at 3 months. |
| Suppuration | Detected by probing or gentle pressure, with purulent exudate confirming presence. | 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. | 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 | From enrollment to the end of treatment at 3 months. |
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
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