Efficacy of Photodynamic Therapy in the Non-Surgical Treatment of Peri-Implantitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mechanical debridment with titanium curettes and ultrasounds, Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy).
- Who it may be relevant to
- Registry conditions: Peri Implantitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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
Primary outcome measures
- Probing Depth [Time frame: From enrollment to the end of treatment at 3 months]
Secondary outcome measures (5)
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Portugal · 1 center
- Egas Moniz School of Health and Science — Almada
Identifiers
NCT: NCT07191522 · aPDT MAA · Research Grant