Efficacy of Photodynamic Therapy in the Non-Surgical Treatment of Peri-Implantitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEgas Moniz - Cooperativa de Ensino Superior, CRL

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mechanical debridment with titanium curettes and ultrasounds

    Procedure/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/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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Study GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 3 months

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 3 months.
2

Bleeding on Probing

Assessed during gentle probing; bleeding indicates a positive site.

Time frame
From enrollment to the end of treatment at 3 months.
3

Suppuration

Detected by probing or gentle pressure, with purulent exudate confirming presence.

Time frame
From enrollment to the end of treatment at 3 months.
4

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.

Time frame
From enrollment to the end of treatment at 3 months.

Other outcomes

Sponsors and contacts

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