Anti-infective Effect of Non-surgical Treatment With and Without Photodynamic Therapy on Initial Peri-implantitis

Phase 3

Completed

• Conditions: Peri-implantitis
• Interventions: Procedure: Mechanical debridement; Device: Photodynamic therapy; Drug: Irrigation

• Registration Number: NCT02848482
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary

Photodynamic therapy (PDT), also known as photoradiation therapy, phototherapy, or photochemotherapy, involves the use of a photoactive dye (photosensitizer) that is activated by exposure to light of a specific wavelength in the presence of oxygen. In recent years, PDT has been introduced as an important novel disinfection therapy in the field of implant dentistry. The inactivation of microorganisms using PDT has been defined as antimicrobial PDT. PDT has the potential to be an alternative of antibiotics, especially for the treatment of localized infections and oral biofilm. PDT is unlikely to cause bacterial-resistance and is equally effective against antibiotic-resistance and antibiotic-susceptible bacteria.

Inconsistent results have been reported regarding the potential role of PDT as an adjunct to mechanical debridement in the management of peri-implant infection. Thus, the aim of the present trial is to investigate the treatment effect of non-surgical treatment with and without photodynamic therapy on initial peri-implantitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-28
• Study Start: 2017-05-01
• Status Verified: 2019-05
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Male and female subjects, ages over 18.
2. Subjects with at least one implant with initial peri-implantitis: PPD of 4-6mm combined with BOP+, bone loss of 0.5-2mm on peri-apical radiographs compared to the time point of restoration placement.
3. Availability for the 12 month duration of the study.
4. Good general health (ASA classification I-II).
5. Signed Informed Consent Form.

Exclusion Criteria

1. Medically compromised subjects (ASA classification III-V)
2. Pregnant or lactating females.
3. Peri-implant mucositis defined as the absence of radiographic marginal bone loss between restoration placement and pre-screening review.
4. Subjects treated for >2 weeks with any medication known to affect soft tissue condition (e.g. phenytoin, calcium antagonists, cyclosporin, Coumadin and non-steroidal anti-inflammatory drugs) within 1 month of the baseline examination.
5. Unwilling to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Mechanical debridement	Plastic curette will be used to perform the mechanical debridement. Then, irrigation (2% chlorhexidine) will be performed at contaminated sites.
Control group	Irrigation	Plastic curette will be used to perform the mechanical debridement. Then, irrigation (2% chlorhexidine) will be performed at contaminated sites.
Test group	Photodynamic therapy	Plastic curette will be used to perform the mechanical debridement. Then, the addition photodynamic therapy (PDT) will be performed. This will be performed with a set-up for PDT (HELBO Photodynamic Systems, German).
Test group	Mechanical debridement	Plastic curette will be used to perform the mechanical debridement. Then, the addition photodynamic therapy (PDT) will be performed. This will be performed with a set-up for PDT (HELBO Photodynamic Systems, German).

Primary Outcome Measures

Name	Time	Method
Change of percentage of bleeding on probing sites	From baseline to 12 months after treatment	A PQW Williams probe (Hu-Friedy, Chicago Ill, USA)will be used to detect the peri-implant pocket. the percentage of bleeding on probing sites (BOP) will be recorded.

Secondary Outcome Measures

Name	Time	Method
Mucosa recession	From baseline to 12 months after treatment	The distance from mucosa margin to the implant shoulder will be recorded using a PQW Williams probe (Hu-Friedy, Chicago Ill, USA). The alteration of the distance between baseline and follow-up visit will be defined as the mucosa recession.
Change of Probing Pocket Depth	From baseline to 12 months after treatment	Probing Pocket Depth at every site will be assessed as the distance from the gingival margin to the apical end of the pocket using a PQW Williams probe (Hu-Friedy, Chicago Ill, USA).
Change of modified plaque index	From baseline to 12 months after treatment	Modified plaque index 0= No detection of plaque.; 1. Plaque only recognized by running a probe across the smooth marginal surface of the implant. Implants covered by titanium spray in this area always score 1.; 2. Plaque can be seen by the naked eye.; 3. Abundance of soft matter.
Change of clinical attachment level	From baseline to 12 months after treatment
Marginal bone loss	From baseline to 12 months after treatment	Periapical radiographs will be taken at baseline, 3, 6, 9 and 12 month examination. The distance from implant shoulder to the most coronal level of implant-bone contact at the mesial and distal site will be recorded. The alteration of the distance between baseline and follow-up visit will be defined as marginal bone loss.

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, China