Clinical Trials Directory

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

TypeNameDescription
PROCEDUREMechanical debridment with titanium curettes and ultrasoundsRemoval 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

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.