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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KLOX BioPhotonic OraLum Gel + SRP | Experimental | Split-mouth design:the half-mouth randomly selected will be treated with KLOX BioPhotonic OraLum gel (with a LED curing lamp) as an adjunct to SRP. |
|
| Scaling and Root Planing (SRP) | Other | The second half-mouth will be treated with SRP alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLOX BioPhotonic OraLum Gel | Device | Klox BioPhotonic OraLum Gel will be used with a LED curing lamp as an adjunct to conventional non-surgical periodontal treatment (SRP). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, Serious adverse events and incidents | Number of patients with adverse events, serious adverse events and incidents | 3 weeks |
| Ease of performing SRP and time required to perform SRP | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on tissues (Visual examination of tissues) | Visual examination of tissues | 3 weeks |
| Impact on bleeding (Use of Bleeding on Probing (BOP) results) | Use of Bleeding on Probing (BOP) results |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory endpoint: patient's preference questionnaire | 2 weeks |
Inclusion Criteria:
Signed and dated written informed consent form;
Male or female patients aged 18 years old and above;
Good general health, free of systemic diseases such as diabetes, arthritis, HIV infection or genetic disorder that could influence the outcome of the treatment;
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);
Patient has had no periodontal treatment for the last year prior to the study;
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):
Patient demonstrates sufficient plaque control as indicated by a plaque score < 30% after hygiene period;
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:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Seminara, DDM | Dr. Anthony Seminara Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Anthony Seminara Inc. | Montreal | Quebec | H4X 2E9 | Canada |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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| Scaling and Root Planing (SRP) | Procedure | Scaling and Root Planing (SRP) is the conventional non-surgical treatment of chronic periodontitis. |
|
| 2 weeks |
| Impact on Plaque Index (PI) | 2 weeks |
| Impact on Gingival index (GI) | 2 weeks |
| Pain (Visual Analog Scale) | 2 weeks |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |