Periodontitis Chronic Generalized ModerateNCT04027686
Clinical Evaluation of Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Gum Disease
A study testing Laser Therapy and Non-surgical Scaling and Root Planing in people with Periodontitis Chronic Generalized Moderate and Periodontitis Chronic Generalized Severe, run by University of California, Los Angeles.
Trial summary
The use of lasers to treat various problems in dentistry is growing as it has in medicine. One application is the use of lasers to treat periodontal disease. It has been suggested that the laser may reduce the need for surgical treatment by reducing pockets. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis Chronic Generalized Moderate, Periodontitis Chronic Generalized Severe
- What is being tested?
- Laser Therapy and Non-surgical Scaling and Root Planing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years old or older (male or female)
- Healthy without systemic diseases that may adversely effect healing
- Not pregnant and no current plans to become pregnant
- No periodontal treatment in the previous 12 months
- No systemic antibiotic therapy in the previous 6 months
- At least two quadrants with periodontitis (ideally opposite side same jaw)
- Each quadrant must have two or more sites with probing pocket depths ≥ 5mm
- Each quadrant should include interproximal intrabony defect(s)
Who cannot join
- Any systemic disease, medication, or habit known to adversely influence bone metabolism and/or wound healing:
- Poorly controlled diabetes (HbA1c > 7%)
- History of bisphosphonate medications
- History of radiation therapy affecting the proposed treatment site(s)
- History of immunosuppressive medications (e.g. corticosteroids)
- History of tobacco use (current or past tobacco use within the past 1 year)
Show all 10Show fewer
- Immune compromise caused by disease, treatment or other condition
- Recent history of periodontal surgery (within the previous 2 years)
- Recent history of scaling and root planing (within the previous 12 months)
- Any condition that contraindicates periodontal therapy including surgery
About this study
Official title: Clinical Evaluation of WaterLase (iPlus) Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Chronic Periodontitis: A Randomized, Controlled, Split-Mouth Clinical Study
The use of lasers to treat various problems in dentistry is growing as it has in medicine. One application is the use of lasers to treat periodontal disease. It has been suggested that the laser may reduce the need for surgical treatment by reducing pockets. The goal of this study is to evaluate the effectiveness of laser treatment for periodontal disease. Laser therapy will be used in addition to traditional non-surgical scaling and root planing (deep cleaning). The information obtained from this study will provide an objective assessment of adjunctive laser therapy compared to conventional periodontal therapy and will attempt to show the benefits, if any, lasers can provide in the treatment of chronic periodontal disease.
- Being tested
- Laser Therapy, Non-surgical Scaling and Root Planing
- Keywords
- Laser Therapy, Non-surgical periodontal therapy, Scaling and root planing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TherapyDevice
Adjunctive application of laser therapy in the periodontal pocket
Non-surgical Scaling and Root PlaningProcedure or surgery
Scaling to remove calculus deposits and root planing to smooth root surfaces
| Study group | Role | What they receive |
|---|---|---|
| SRP + Adjunctive Laser Therapy | Experimental | Laser therapy used as an adjunct to scaling and root planing Receives: Device: Laser Therapy; Procedure: Non-surgical Scaling and Root Planing |
| SRP alone | Active comparator | Scaling and root planing used as conventional non-surgical periodontal therapy Receives: Procedure: Non-surgical Scaling and Root Planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth
This is a measure from base of pocket to gingival margin.
Measured: 12 months
Sites That Bleed on Probing
Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement.
Measured: 12 months
Gingival Recession
Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction.
Measured: 12 months
Clinical Attachment Level
Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession).
Measured: 12 months
Secondary outcomes (2)
Periodontal Microbiome
Assess changes in periodontal microbiome using DNA sequencing
Measured: 12 months
Patient Reported Outcomes: VAS Questionnaire
Measure patient reported pain (0-100), comfort (0-100), sensitivity (0-100) and satisfaction (0-100) using VAS questionnaire, with lower values indicating better outcome for pain and sensitivity and higher values indicating better outcome for comfort and satisfaction.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study startJan 2017
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Periodontitis Chronic Generalized ModerateStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Randomized, Controlled, Split-mouth
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Biolase Inc
- Responsible party
- Principal investigator, Perry R Klokkevold, DDS, MS, University of California, Los Angeles
- Investigators
- Perry R Klokkevold, DDS, MS, Principal investigator, UCLA School of Dentistry, Section of Periodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027686
- Sponsor's protocol ID
- IRB#15-000519
- Status last verified
- Feb 2021
- First submitted
- 18 Jul 2019
- Last updated
- 5 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of WaterLase (iPlus) Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Chronic Periodontitis: A Randomized, Controlled, Split-Mouth Clinical Study
- ClinicalTrials.gov ID
- NCT04027686
- Acronym / sponsor ID
- IRB#15-000519
- Keywords
- Laser Therapy, Non-surgical periodontal therapy, Scaling and root planing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Biolase Inc
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Posted 5 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of lasers to treat various problems in dentistry is growing as it has in medicine. One application is the use of lasers to treat periodontal disease. It has been suggested that the laser may reduce the need for surgical treatment by reducing pockets. The goal of this study is to evaluate the effectiveness of laser treatment for periodontal disease. Laser therapy will be used in addition to traditional non-surgical scaling and root planing (deep cleaning). The information obtained from this study will provide an objective assessment of adjunctive laser therapy compared to conventional periodontal therapy and will attempt to show the benefits, if any, lasers can provide in the treatment of chronic periodontal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Controlled, Split-mouth
| Arm | Type | Receives |
|---|---|---|
| SRP + Adjunctive Laser Therapy | Experimental | Device: Laser Therapy, Procedure: Non-surgical Scaling and Root PlaningLaser therapy used as an adjunct to scaling and root planing |
| SRP alone | Active comparator | Procedure: Non-surgical Scaling and Root PlaningScaling and root planing used as conventional non-surgical periodontal therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years old or older (male or female)
- Healthy without systemic diseases that may adversely effect healing
- Not pregnant and no current plans to become pregnant
- No periodontal treatment in the previous 12 months
- No systemic antibiotic therapy in the previous 6 months
Key exclusion criteria (10 listed)
- Any systemic disease, medication, or habit known to adversely influence bone metabolism and/or wound healing:
- Poorly controlled diabetes (HbA1c > 7%)
- History of bisphosphonate medications
- History of radiation therapy affecting the proposed treatment site(s)
- History of immunosuppressive medications (e.g. corticosteroids)
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 |
|---|---|---|
| Laser TherapyAdjunctive application of laser therapy in the periodontal pocket | Device | SRP + Adjunctive Laser Therapy |
| Non-surgical Scaling and Root PlaningScaling to remove calculus deposits and root planing to smooth root surfaces | Procedure or surgery | SRP + Adjunctive Laser Therapy, SRP alone |
Primary outcome
Probing Pocket Depth
Time frame: 12 months
This is a measure from base of pocket to gingival margin.
Sites That Bleed on Probing
Time frame: 12 months
Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement.
Gingival Recession
Time frame: 12 months
Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction.
Clinical Attachment Level
Time frame: 12 months
Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession).
2 secondary outcomes
Periodontal Microbiome
Time frame: 12 months
Patient Reported Outcomes: VAS Questionnaire
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Periodontitis Chronic Generalized Moderate
RecruitingPhase 2
3-Month Clinical Trial of Liquid S-PRF in Periodontal Debridement for Periodontitis Stages II-IV
Periodontitis Stage II, Periodontitis Stage III
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.
Perry R Klokkevold, DDS, MS principal investigator
UCLA School of Dentistry, Section of Periodontics
Questions about this trial
What is this clinical trial studying?
A study testing Laser Therapy and Non-surgical Scaling and Root Planing in people with Periodontitis Chronic Generalized Moderate and Periodontitis Chronic Generalized Severe, run by University of California, Los Angeles.
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 10 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 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 5 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Probing Pocket Depth (time frame: 12 months). The study lists 4 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 5 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.