Evaluation of the KLOX BioPhotonic OraLum Gel With a LED Curing Lamp in Moderate to Severe Chronic Periodontitis

Moderate to Severe Chronic Periodontitis Clinical Trial

Official title:

The Evaluation of the Clinical Effects of the KLOX BioPhotonic OraLum Gel With a LED Curing Lamp as an Adjunct to the Non-Surgical Treatment of Moderate to Severe Chronic Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325570
• Other study ID #: CL-K1004-P001
• Status: Completed
• Phase: N/A
• First received: December 17, 2014
• Last updated: February 22, 2016
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: KLOX Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Multicenter, prospective, interventional open case series study using a randomized split-mouth design in moderate to severe chronic periodontitis patients having half-mouth treated with the KLOX BioPhotonic OraLum gel with a LED curing lamp as an adjunct to conventional non-surgical periodontal treatment (SRP) versus SRP alone in the second (control) half-mouth.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed and dated written informed consent form;

2. Male or female patients aged 18 years old and above;

3. Good general health, free of systemic diseases such as diabetes, arthritis, HIV infection or genetic disorder that could influence the outcome of the treatment;

4. Patient with clinically confirmed signs and symptoms of generalized moderate to severe chronic periodontitis (as defined according to International Classification of Periodontal Diseases, Armitage 1999);

5. Patient has had no periodontal treatment for the last year prior to the study;

6. Females of childbearing potential must not be pregnant nor lactating at study entry and agree to use an adequate contraceptive method during the study.

Inclusion Criteria Post Oral Hygiene Instructions (OHI):

7. Patient demonstrates sufficient plaque control as indicated by a plaque score < 30% after hygiene period;

8. Patient has at least two sites in each quadrant with probing pocket depth (PPD) equal or more than 5 mm or equal or less than 7 mm.

Exclusion Criteria:

1. Patient with an existing aggressive periodontitis;

2. Presence of oral local mechanical factor(s) that could, in the opinion of the investigator, influence the outcome of the study;

3. Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed;

4. Soft or hard tissue tumours of the oral cavity;

5. Systemic antibiotic therapy or anti-inflammatory drugs or any other medication(s) that might interfere with periodontal healing within the last three months prior to study entry and throughout the study duration;

6. Patient has participated in any other clinical study within 30 days prior to study entry and throughout the study duration;

7. Use of anticoagulants such as warfarin, clopidogrel, enoxaparin or high doses of aspirin (162 mg daily);

8. Regular use of chlorhexidine oral rinses / mouthwashes (Non-medicated, over the counter, mouthwashes are acceptable);

9. Patient with current alcohol abuse or actively consuming drugs (addiction); as it may interfere with patient's ability to comply with study procedures

10. Periodontal surgery planned during the study;

11. Female patient pregnant, nursing or planning to become pregnant within the next 12 months;

12. Patient is a current smoker or had been smoking or using nicotine product(s) in the last six months;

13. Concurrent disease (such as porphyria) or drug(s) (such as methotrexate or chloroquine) known to induce severe photosensitivity of the skin;

14. Patient has ongoing malignant disease of any type, or any significant chronic disease which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or would result in non-compliance with the study protocol;

15. Patients with known hypersensitivity to peroxide;

16. Patients with known photosensitivity or who take drugs to treat photosensitivity.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Moderate to Severe Chronic Periodontitis
• Periodontitis

Intervention

Device:
• KLOX BioPhotonic OraLum Gel
Klox BioPhotonic OraLum Gel will be used with a LED curing lamp as an adjunct to conventional non-surgical periodontal treatment (SRP).

Procedure:
• Scaling and Root Planing (SRP)
Scaling and Root Planing (SRP) is the conventional non-surgical treatment of chronic periodontitis.

Locations

Country	Name	City	State
Canada	Dr. Anthony Seminara Inc.	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
KLOX Technologies Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory endpoint: patient's preference questionnaire		2 weeks	No
Primary	Adverse events, Serious adverse events and incidents	Number of patients with adverse events, serious adverse events and incidents	3 weeks	No
Primary	Ease of performing SRP and time required to perform SRP		2 weeks	No
Secondary	Impact on tissues (Visual examination of tissues)	Visual examination of tissues	3 weeks	No
Secondary	Impact on bleeding (Use of Bleeding on Probing (BOP) results)	Use of Bleeding on Probing (BOP) results	2 weeks	No
Secondary	Impact on Plaque Index (PI)		2 weeks	No
Secondary	Impact on Gingival index (GI)		2 weeks	No
Secondary	Pain (Visual Analog Scale)		2 weeks	No