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

Peri-implantitis Clinical Trial

Official title:

Anti-infective Effect of Non-surgical Treatment With and Without Photodynamic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848482
• Other study ID #: 1036_2016
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2019
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peri-implantitis

Intervention

Device:
• Photodynamic therapy
Photodynamic therapy (HELBO Photodynaimc Systems GmbH, Wels, Austria)

Procedure:
• Mechanical debridement
Plastic scalers (Have implantrecallset, Kerr, Italy) will be used to curette the contaminated sites.

Drug:
• Irrigation
0.2% chlorhexidine digluconate solution (Bioworld, Madision, US) will be irrigated at contaminated sites for 1 minute.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of percentage of bleeding on probing sites	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.	From baseline to 12 months after treatment
Secondary	Change of Probing Pocket Depth	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).	From baseline to 12 months after treatment
Secondary	Change of modified plaque index	Modified plaque index 0= No detection of plaque.; 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.; Plaque can be seen by the naked eye.; Abundance of soft matter.	From baseline to 12 months after treatment
Secondary	Change of clinical attachment level		From baseline to 12 months after treatment
Secondary	Marginal bone loss	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.	From baseline to 12 months after treatment
Secondary	Mucosa recession	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.	From baseline to 12 months after treatment