Efficacy of Adjunctive Antimicrobial Photodynamic Therapy for Residual Pockets in Previously Surgically Treated Teeth

NCT03757260 | Unknown

• 1 other identifier: B2018:012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Traditionally, periodontal gum surgery has been used as a method to gain access to inflamed periodontal pockets around teeth. The outcome of these surgeries, however, is not always successful as there can be recurrence of inflammation and disease. The objective of this study is to assess the effectiveness of antimicrobial photodynamic therapy as an adjunct to mechanical debridement of residual periodontal pockets in patients having undergone periodontal surgery. Pocket probing depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) will be evaluated at all sites as measures of inflammation and disease resolution.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in bleeding on probing (BOP)

  Change in the presence of bleeding upon probing on individual tooth surfaces at 3 months, 6 months, and 12 months compared to the initial measure.

  Initial, 3 months, 6 months, 12 months.

Secondary Outcomes (3)

• Change in pocket probing depth (PPD)

  Initial, 3 months, 6 months, 12 months.

• Change of clinical attachment level (CAL)

  Initial, 3 months, 6 months, 12 months.

• Change of plaque index (PI)

  Initial, 3 months, 6 months, 12 months.

Study Arms (2)

Treatment Group

EXPERIMENTAL

Antimicrobial photodynamic therapy with methylene blue applied to test site after mechanical debridement.

Device: Antimicrobial photodynamic therapy

Placebo Group

PLACEBO COMPARATOR

Photodynamic therapy laser is not activated with saline water in the test site after mechanical debridement.

Device: Placebo of photodynamic therapy

Interventions

Antimicrobial photodynamic therapy DEVICE

Antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system. The photosensitizing agent is methylene blue. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is illuminated for 60 seconds to activate the agent using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power).

Also known as: "Periowave" trade name

Treatment Group

Placebo of photodynamic therapy DEVICE

The placebo of the antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system. The photosensitizing agent is saline solution. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is not illuminated (falsely activated) for 60 seconds using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power).

Also known as: Placebo of "Periowave" trade name

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy
• Enrolled in a supportive periodontal therapy program and a patient at the University of Manitoba Graduate Periodontics Clinic
• At least one surgically treated periodontal site with a residual pocket probing depth of ≥ 5mm and bleeding upon probing
• Completed informed consent

You may not qualify if:

• Patients with uncontrolled diabetes mellitus
• Patients with cancer
• Patients with HIV
• Patients with bone metabolic diseases
• Patients with disorders that compromise wound healing
• Patients undergoing radiation or immunosuppressive therapy
• Pregnancy or lactation
• Have had antibiotics therapy within the last three months
• Confirmed or suspected intolerance to methylene blue
• Any physical limitations or restrictions that might preclude normal oral hygiene procedures

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0W3, Canada

Location

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MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Anastasia Cholakis, M Dent

  University of Manitoba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Once selected the patient will see two clinicians: the examiner (hygienist) and operator (resident). The examiner records the data (PPD, CAL, BOP, PI) of the teeth, and provides preliminary hygiene treatment; the operator delivers the test treatments. The treatment assignments are concealed to the patient and the examiner. The operator is unaware of previously recorded data except for pocket depth measurements and is not involved in the post-treatment evaluations (3,6,12 months)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 28, 2018
• Study Start: January 8, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After conclusion of the study up until 5 years after completion of the study.

Locations

CA (1)