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

Sponsor

University of Manitoba (Other)

Overall Status

Unknown status

CT.gov ID

NCT03757260

Collaborator

(none)

Enrollment

Location

Arms

18.8

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Device: Antimicrobial photodynamic therapy Device: Placebo of photodynamic therapy	N/A

Detailed Description

A single-center, randomized, double-blind, longitudinal study will take place over 12 months. Twenty-eight systemically healthy patients (i.e. absence of uncontrolled diabetes mellitus, cancer, HIV, bone metabolic diseases, or disorders that compromise wound healing) enrolled in a supportive periodontal therapy program and patients at the University of Manitoba Graduate Periodontics Clinic, with at least one surgically treated site with a residual pocket probing depth of ≥ 5mm and bleeding upon probing and having signed the informed consent will be accepted into the study. PPD, CAL, BOP, and PI will be evaluated at these sites. A selected participant will have a full mouth periodontal charting completed prior to baseline measurements as part of their maintenance program.

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 entire dentition including the selected tooth or 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). At 12 months, a full mouth re-evaluation will be completed by the examiner as part of the patient's maintenance program.

In the first visit, the examiner records the pocket probing depth, clinical attachment level, presence of bleeding on probing, and plaque index at six sites on involved teeth. Thorough scaling and root planing is performed under local anesthesia using periodontal curettes (Gracey, Hu-Friedy, USA) and an ultrasonic device (Piezo, Ultradent, USA). Once complete, the operator takes over. The patients are then randomly assigned to test or control groups by a computer-generated table. The protocol may be: A, the laser is activated during treatments with methylene blue; B, the laser is never activated during treatments with saline solution.

Antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system (Ondine Biomedical Inc, Vancouver, Canada). 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). The control treatment consists of the same procedure, except that the photosensitizer is replaced with saline solution and the light-diffusing tip is kept in the pocket for 60 seconds without activating the laser. The patient is sent home with a home care package and oral hygiene instructions.

The second session is scheduled after 1 week. The operator applies the photosensitizer and activates the laser according to protocol A or B. The examiner maintains the patients on a 3-month hygiene schedule and reassesses the participants 3, 6, and 12 months after the treatment as well as reinforces oral hygiene instruction. Medical history, concomitant medication, and all adverse events are recorded. Clinical parameters are measured the same way as at baseline. All measurements will be calibrated.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

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)

Primary Purpose:

Treatment

Official Title:

The Efficacy of Adjunctive Antimicrobial Photodynamic Therapy for Residual Pockets in Previously Surgically Treated Teeth: a Randomized Clinical Trial.

Actual Study Start Date :

Jan 8, 2019

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group Antimicrobial photodynamic therapy with methylene blue applied to test site after mechanical debridement.	Device: Antimicrobial photodynamic therapy 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). Other Names: "Periowave" trade name
Placebo Comparator: Placebo Group Photodynamic therapy laser is not activated with saline water in the test site after mechanical debridement.	Device: Placebo of photodynamic therapy 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). Other Names: Placebo of "Periowave" trade name

Arm

Intervention/Treatment

Experimental: Treatment Group

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

Device: Antimicrobial photodynamic therapy

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).

Other Names:

"Periowave" trade name

Placebo Comparator: Placebo Group

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

Device: Placebo of photodynamic therapy

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).

Other Names:

Placebo of "Periowave" trade name

Outcome Measures

Primary Outcome Measures

Change in bleeding on probing (BOP) [Initial, 3 months, 6 months, 12 months.]
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.

Secondary Outcome Measures

Change in pocket probing depth (PPD) [Initial, 3 months, 6 months, 12 months.]
Change of the distance from the gingival margin to the tip of the periodontal probe at the bottom of the gingival pocket at 3 months, 6 months, and 12 months compared to the initial measure.
Change of clinical attachment level (CAL) [Initial, 3 months, 6 months, 12 months.]
Change of the distance from the cemento-enamel junction to the tip of the periodontal probe at the bottom of the gingival pocket at 3 months, 6 months, and 12 months compared to the initial measure.
Change of plaque index (PI) [Initial, 3 months, 6 months, 12 months.]
Change in the presence of plaque on individual tooth surfaces at 3 months, 6 months, and 12 months compared to the initial measure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Manitoba	Winnipeg	Manitoba	Canada	R3E 0W3

Sponsors and Collaborators

University of Manitoba

Investigators

Study Director: Anastasia Cholakis, M Dent, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Javier Cabrales, Principal Investigator, University of Manitoba

ClinicalTrials.gov Identifier:

NCT03757260

Other Study ID Numbers:

B2018:012

First Posted:

Nov 28, 2018

Last Update Posted:

Oct 1, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Anti-Infective Agents

Anti-Bacterial Agents

Study Results

No Results Posted as of Oct 1, 2019