Moderate to Severe Chronic PeriodontitisNCT02325570
Evaluation of the KLOX BioPhotonic OraLum Gel With a LED Curing Lamp in Moderate to Severe Chronic Periodontitis
A study testing KLOX BioPhotonic OraLum Gel and Scaling and Root Planing (SRP) in people with Moderate to Severe Chronic Periodontitis, run by KLOX Technologies Inc. at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Chronic Periodontitis
- What is being tested?
- KLOX BioPhotonic OraLum Gel and Scaling and Root Planing (SRP)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- Patient with an existing aggressive periodontitis;
- Presence of oral local mechanical factor(s) that could, in the opinion of the investigator, influence the outcome of the study;
- Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed;
- Soft or hard tissue tumours of the oral cavity;
- 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;
- Patient has participated in any other clinical study within 30 days prior to study entry and throughout the study duration;
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- Use of anticoagulants such as warfarin, clopidogrel, enoxaparin or high doses of aspirin (162 mg daily);
- Regular use of chlorhexidine oral rinses / mouthwashes (Non-medicated, over the counter, mouthwashes are acceptable);
- Patient with current alcohol abuse or actively consuming drugs (addiction); as it may interfere with patient's ability to comply with study procedures
- Periodontal surgery planned during the study;
- Female patient pregnant, nursing or planning to become pregnant within the next 12 months;
- Patient is a current smoker or had been smoking or using nicotine product(s) in the last six months;
- Concurrent disease (such as porphyria) or drug(s) (such as methotrexate or chloroquine) known to induce severe photosensitivity of the skin;
- 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;
- Patients with known hypersensitivity to peroxide;
- Patients with known photosensitivity or who take drugs to treat photosensitivity.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Moderate to Severe Chronic Periodontitis
- Being tested
- KLOX BioPhotonic OraLum Gel, Scaling and Root Planing (SRP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLOX BioPhotonic OraLum GelDevice
Klox BioPhotonic OraLum Gel will be used with a LED curing lamp as an adjunct to conventional non-surgical periodontal treatment (SRP).
Scaling and Root Planing (SRP)Procedure or surgery
Scaling and Root Planing (SRP) is the conventional non-surgical treatment of chronic periodontitis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: KLOX BioPhotonic OraLum Gel; Procedure: Scaling and Root Planing (SRP) |
| Scaling and Root Planing (SRP) | Other | The second half-mouth will be treated with SRP alone. Receives: Procedure: Scaling and Root Planing (SRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, Serious adverse events and incidents
Number of patients with adverse events, serious adverse events and incidents
Measured: 3 weeks
Ease of performing SRP and time required to perform SRP
Measured: 2 weeks
Secondary outcomes (5)
Impact on tissues (Visual examination of tissues)
Visual examination of tissues
Measured: 3 weeks
Impact on bleeding (Use of Bleeding on Probing (BOP) results)
Use of Bleeding on Probing (BOP) results
Measured: 2 weeks
Impact on Plaque Index (PI)
Measured: 2 weeks
Impact on Gingival index (GI)
Measured: 2 weeks
Pain (Visual Analog Scale)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- KLOX Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Seminara, DDM, Principal investigator, Dr. Anthony Seminara Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325570
- Sponsor's protocol ID
- CL-K1004-P001
- Status last verified
- Feb 2016
- First submitted
- 17 Dec 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02325570
- Acronym / sponsor ID
- CL-K1004-P001
- Conditions
- Moderate to Severe Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- KLOX Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KLOX BioPhotonic OraLum Gel + SRP | Experimental | Device: KLOX BioPhotonic OraLum Gel, Procedure: Scaling and Root Planing (SRP)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 | Procedure: Scaling and Root Planing (SRP)The second half-mouth will be treated with SRP alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (16 listed)
- Patient with an existing aggressive periodontitis;
- Presence of oral local mechanical factor(s) that could, in the opinion of the investigator, influence the outcome of the study;
- Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed;
- Soft or hard tissue tumours of the oral cavity;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KLOX BioPhotonic OraLum GelKlox BioPhotonic OraLum Gel will be used with a LED curing lamp as an adjunct to conventional non-surgical periodontal treatment (SRP). | Device | KLOX BioPhotonic OraLum Gel + SRP |
| Scaling and Root Planing (SRP)Scaling and Root Planing (SRP) is the conventional non-surgical treatment of chronic periodontitis. | Procedure or surgery | KLOX BioPhotonic OraLum Gel + SRP, Scaling and Root Planing (SRP) |
Primary outcome
Adverse events, Serious adverse events and incidents
Time frame: 3 weeks
Number of patients with adverse events, serious adverse events and incidents
Ease of performing SRP and time required to perform SRP
Time frame: 2 weeks
5 secondary outcomes
Impact on tissues (Visual examination of tissues)
Time frame: 3 weeks
Impact on bleeding (Use of Bleeding on Probing (BOP) results)
Time frame: 2 weeks
Impact on Plaque Index (PI)
Time frame: 2 weeks
Impact on Gingival index (GI)
Time frame: 2 weeks
Pain (Visual Analog Scale)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Seminara, DDM principal investigator
Dr. Anthony Seminara Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KLOX BioPhotonic OraLum Gel and Scaling and Root Planing (SRP) in people with Moderate to Severe Chronic Periodontitis, run by KLOX Technologies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events, Serious adverse events and incidents (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.