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

NCT07191522 | Recruiting

• 2 other identifiers: aPDT MAAResearch Grant
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri Implantitis

Keywords

Peri-implantitis; Antimicrobial Photodynamic Therapy

Outcome Measures

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.

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (5)

• Clinical attachment level

  From enrollment to the end of treatment at 3 months.

• Bleeding on Probing

  From enrollment to the end of treatment at 3 months.

• Suppuration

  From enrollment to the end of treatment at 3 months.

• Radiographic bone level

  From enrollment to the end of treatment at 3 months.

• Microbiology outcome

  From enrollment to the end of treatment at 3 months.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Mechanical debridment with titanium curettes and ultrasounds

Procedure: Mechanical debridment with titanium curettes and ultrasounds

Study Group

EXPERIMENTAL

Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy)

Procedure: Mechanical debridment with titanium curettes and ultrasounds + aPDT (antimicrobial photodynamic therapy)

Interventions

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

Control Group

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

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead

Study Sites (1)

Egas Moniz School of Health and Science

Almada, Monte Da Caparica, 2829-511, Portugal

RECRUITING

Related Links

• LED website

MeSH Terms

Conditions

Peri-Implantitis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Ricardo Alves, PhD

  Egas Moniz School of Health and Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana A Assunção, Master

CONTACT

+351919970304; massuncao@egasmoniz.edu.pt

Inês Gomes, PhD

CONTACT

212946748; inesgomes.ciiem@egasmoniz.edu.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 25, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)