Chronic PeriodontitisNCT03003689
Effects of Scaling and Root Planing With and Without Er:YAG Laser in Chronic Periodontitis Patients
A study testing Scaling and Root Planing and Er:YAG Laser in people with Chronic Periodontitis, run by Tufts University School of Dental Medicine at 1 site in United States.
Trial summary
Dental bacterial plaque is the most frequent modifiable finding in patients with periodontal (gum) diseases. Many studies have provided evidence that mechanical removal of dental plaque is critical for improving the periodontal health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Scaling and Root Planing and Er:YAG Laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2017to Mar 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients enrolled in the Post-Graduate Periodontology Clinic at Tufts University School of Dental Medicine (TUSDM)
- Recent (within the past 30 days) diagnosis of moderate to severe chronic periodontitis in at least two quadrants according to the Armitage Classification
- Have had full mouth and vertical bite-wing series of diagnostic radiographs exposed at TUSDM within 6 months preceding entry of the study as a standard of care
- Have a treatment plan made by the original provider and certified by the PI based on the working diagnosis, presenting etiology, and the predicted therapeutic outcomes of the case (prognosis).
- Each of the two selected quadrants should have at least 5 teeth including the canine, first premolar and second premolar in contact with at least one tooth that has ≥ 5 mms and ≤ 9 mms probing depths with bleeding on probing.
Who cannot join
- Participants must not have had mechanical debridement or any other professional periodontal therapy within 6 months preceding entering the study
- Participants with significant chronic oral soft tissue pathology (lichen planus, Benign Mucous Membrane Pemphigoid, Steven Johnson's Syndrome, Sjogren's Syndrome, etc.) which might affect host response to the presence of bacteria.
- Participants with fixed appliances or partial dentures, to standardize the effect of the treatment since they are plaque retentive.
- Participants who smoke tobacco
- Participants who require prophylactic antibiotics prior to dental treatment
- Participants who have taken systemic antibiotic medications within the previous 6 months
Show all 10Show fewer
- Participants with uncontrolled systemic conditions or disease such as diabetes and immunological disorders
- Participants with known drug allergies or known adverse effects following the use of oral hygiene products.
- Participants who are pregnant or lactating
- Teeth with grade III mobility or teeth with hopeless prognosis indicated for extraction
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
Charles Hawley, DDS, MS, PhD
About this study
Official title: Randomized Clinical Trial Assessing the Clinical Outcomes and Recolonization Patterns Following Scaling and Root Planing With and Without Using Er.YAG Laser in Chronic Periodontitis Patients
Dental bacterial plaque is the most frequent modifiable finding in patients with periodontal (gum) diseases. Many studies have provided evidence that mechanical removal of dental plaque is critical for improving the periodontal health. The standard initial treatment of periodontitis (gum disease) is to remove plaque and calculus form the teeth and root structures using sclaing and root planing (SRP). Typically hand instruments and an ultrasonic scaler are used for SRP
While this method removes some of the bacteria that leads to periodontitis, microorganisms are not completely eliminated through SRP. Studies have shown that after 3 months, the bacteria initially present prior to scaling and root planing had recolonized. In order to prevent recurrence of periodontitis, it is recommended that oral bacteria be kept at low levels.
Read more
When used at the proper wave length, dental lasers have been shown to effectively removes calculus, without damaging surrounding tissue. The Er:YAG laser has been FDA-approved for the use of scaling and root planing in Dentistry. While studies on the Er:YAG laser have shown that it is effective in removing calculus and preserving the tooth root structure, there is no consensus of the level of calculus removal. The Er:YAG laser may also be more effective in removing microbial bacteria than SRP with hand instruments and ultrasonic scaler.
The purpose of this study is to evaluate the effectiveness of the Er:YAG laser, as an adjunct to scaling and root planing, in removing microbial bacteria. Participants with chronic periodontitis will be randomized to have one quadrant undergo scaling and root planing using hand instruments and ultrasonic scaler alone, while a second quadrant will receive the same treatment, with the addition of the Er:YAG laser. Outcomes studies will be traditional periodontal clinical parameters at 6 weeks and 3 months after treatment. Microbial cultures will be performed at baseline and 3 months to compare survival and re-population by periodontal microorganisms.
Read the detailed description
Primary Aim: The primary aim of this study is to evaluate the efficacy of Er:YAG laser as an adjunct to mechanical scaling and root planing periodontal therapy by comparing probing depth and clinical attachment levels.
Secondary aim: The secondary aim of this study is to evaluate the efficacy of Er:YAG laser as an adjunct to mechanical scaling and root planing periodontal therapy by comparing gingival bleeding index and plaque index.
Tertiary aim: The tertiary aim of this study is to compare the microbial outcomes of mechanical periodontal therapy alone vs. mechanical therapy combined followed with Er:YAG laser therapy at the same time.
- Conditions
- Chronic Periodontitis
- Being tested
- Scaling and Root Planing, Er:YAG Laser
- Keywords
- Scaling and Root Planing, Er:YAG
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root PlaningProcedure or surgery
Standard of care scaling and root planing using hand instruments and ultrasonic scaler
Er:YAG LaserDevice
Er:YAG laser as an adjunct therapy to standard of care scaling and root planing using hand instruments and ultrasonic
| Study group | Role | What they receive |
|---|---|---|
| Scaling and Root Planing | Active comparator | Hand instruments + ultrasonic scaler
PD, CAL, plaque index and gingival bleeding index will be measured at baseline, 6 weeks and 3 months. Microbial load will be measured at baseline and 3 months. Receives: Procedure: Scaling and Root Planing |
| Scaling and Root Planing + Er:YAG Laser | Experimental | Er:YAG Laser, hand instruments + ultrasonic scaler
PD, CAL, plaque index and gingival bleeding index will be measured at baseline, 6 weeks and 3 months. Microbial load will be measured at baseline and 3 months. Receives: Procedure: Scaling and Root Planing; Device: Er:YAG Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Depth
Differences in pocket depth reduction between laser treatment and control groups will be analyzed with a linear mixed effects model. Four sites (mesiolingual, mesiobuccal, distolingual, and distobuccal) per tooth will be averaged and used in the linear mixed effects model. Normality of the data will be assessed graphically and with the Shapiro-Wilk test.
Measured: Up to 3 months
Change in Clinical Attachment Levels
Differences in attachment gain between laser treatment and control groups will be analyzed with a linear mixed effects model. Four sites (mesiolingual, mesiobuccal, distolingual, and distobuccal) per tooth will be averaged and used in the linear mixed effects model. Normality of the data will be assessed graphically and with the Shapiro-Wilk test.
Measured: Up to 3 months
Secondary outcomes (3)
Change in Gingival Bleeding Index
The gingival bleeding index (the number of bleeding sites divided by the total number of sites) will be calculated. Statistical significance between the two groups' gingival bleeding index will be determined with generalized estimating equations.
Measured: Up to 3 months
Change in Plaque Index
The plaque index (the number of surfaces with plaque divided by the total number of surfaces) will be calculated. Statistical significance between the two groups' plaque index will be determined with generalized estimating equations.
Measured: Up to 3 months
Change in microbial load, measured in Colony Forming Units (CFUs)
Microbial load will be measured by the total number of cultivable bacteria measured by total viable colony forming units (CFUs) on non-selective and selective media. Percent cultivability of periodontal pathogens will be measured by number of pathogen specific CFUs in proportion to total cultivability.
Differences in microbial load will be investigated with the paired t-test. If the assumption of normality is unmet, the Wilcoxon rank-sum test will be used instead.
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start20 Apr 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University School of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Hawley, DDS, MS, PhD, Principal investigator, TUSDM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003689
- Sponsor's protocol ID
- 12321
- Status last verified
- Jan 2018
- First submitted
- 9 Dec 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Assessing the Clinical Outcomes and Recolonization Patterns Following Scaling and Root Planing With and Without Using Er.YAG Laser in Chronic Periodontitis Patients
- ClinicalTrials.gov ID
- NCT03003689
- Acronym / sponsor ID
- 12321
- Conditions
- Chronic Periodontitis
- Keywords
- Scaling and Root Planing, Er:YAG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Tufts University School of Dental MedicineUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 28 Dec 2016 (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.
Dental bacterial plaque is the most frequent modifiable finding in patients with periodontal (gum) diseases. Many studies have provided evidence that mechanical removal of dental plaque is critical for improving the periodontal health. The standard initial treatment of periodontitis (gum disease) is to remove plaque and calculus form the teeth and root structures using sclaing and root planing (SRP). Typically hand instruments and an ultrasonic scaler are used for SRP
While this method removes some of the bacteria that leads to periodontitis, microorganisms are not completely eliminated through SRP. Studies have shown that after 3 months, the bacteria initially present prior to scaling and root planing had recolonized. In order to prevent recurrence of periodontitis, it is recommended that oral bacteria be kept at low levels.
When used at the proper wave length, dental lasers have been shown to effectively removes calculus, without damaging surrounding tissue. The Er:YAG laser has been FDA-approved for the use of scaling and root planing in Dentistry. While studies on the Er:YAG laser have shown that it is effective in removing calculus and preserving the tooth root structure, there is no consensus of the level of calculus removal. The Er:YAG laser may also be more effective in removing microbial bacteria than SRP with hand instruments and ultrasonic scaler.
The purpose of this study is to evaluate the effectiveness of the Er:YAG laser, as an adjunct to scaling and root planing, in removing microbial bacteria. Participants with chronic periodontitis will be randomized to have one quadrant undergo scaling and root planing using hand instruments and ultrasonic scaler alone, while a second quadrant will receive the same treatment, with the addition of the Er:YAG laser. Outcomes studies will be traditional periodontal clinical parameters at 6 weeks and 3 months after treatment. Microbial cultures will be performed at baseline and 3 months to compare survival and re-population by periodontal microorganisms.
Detailed description
Primary Aim: The primary aim of this study is to evaluate the efficacy of Er:YAG laser as an adjunct to mechanical scaling and root planing periodontal therapy by comparing probing depth and clinical attachment levels.
Secondary aim: The secondary aim of this study is to evaluate the efficacy of Er:YAG laser as an adjunct to mechanical scaling and root planing periodontal therapy by comparing gingival bleeding index and plaque index.
Tertiary aim: The tertiary aim of this study is to compare the microbial outcomes of mechanical periodontal therapy alone vs. mechanical therapy combined followed with Er:YAG laser therapy at the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scaling and Root Planing | Active comparator | Procedure: Scaling and Root PlaningHand instruments + ultrasonic scaler PD, CAL, plaque index and gingival bleeding index will be measured at baseline, 6 weeks and 3 months. Microbial load will be measured at baseline and 3 months. |
| Scaling and Root Planing + Er:YAG Laser | Experimental | Procedure: Scaling and Root Planing, Device: Er:YAG LaserEr:YAG Laser, hand instruments + ultrasonic scaler PD, CAL, plaque index and gingival bleeding index will be measured at baseline, 6 weeks and 3 months. Microbial load will be measured at baseline and 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients enrolled in the Post-Graduate Periodontology Clinic at Tufts University School of Dental Medicine (TUSDM)
- Recent (within the past 30 days) diagnosis of moderate to severe chronic periodontitis in at least two quadrants according to the Armitage Classification
- Have had full mouth and vertical bite-wing series of diagnostic radiographs exposed at TUSDM within 6 months preceding entry of the study as a standard of care
- Have a treatment plan made by the original provider and certified by the PI based on the working diagnosis, presenting etiology, and the predicted therapeutic outcomes of the case (prognosis).
- Each of the two selected quadrants should have at least 5 teeth including the canine, first premolar and second premolar in contact with at least one tooth that has ≥ 5 mms and ≤ 9 mms probing depths with bleeding on probing.
Key exclusion criteria (10 listed)
- Participants must not have had mechanical debridement or any other professional periodontal therapy within 6 months preceding entering the study
- Participants with significant chronic oral soft tissue pathology (lichen planus, Benign Mucous Membrane Pemphigoid, Steven Johnson's Syndrome, Sjogren's Syndrome, etc.) which might affect host response to the presence of bacteria.
- Participants with fixed appliances or partial dentures, to standardize the effect of the treatment since they are plaque retentive.
- Participants who smoke tobacco
- Participants who require prophylactic antibiotics prior to dental treatment
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 |
|---|---|---|
| Scaling and Root PlaningStandard of care scaling and root planing using hand instruments and ultrasonic scaler | Procedure or surgery | Scaling and Root Planing, Scaling and Root Planing + Er:YAG Laser |
| Er:YAG LaserEr:YAG laser as an adjunct therapy to standard of care scaling and root planing using hand instruments and ultrasonic | Device | Scaling and Root Planing + Er:YAG Laser |
Primary outcome
Change in Probing Depth
Time frame: Up to 3 months
Differences in pocket depth reduction between laser treatment and control groups will be analyzed with a linear mixed effects model. Four sites (mesiolingual, mesiobuccal, distolingual, and distobuccal) per tooth will be averaged and used in the linear mixed effects model. Normality of the data will be assessed graphically and with the Shapiro-Wilk test.
Change in Clinical Attachment Levels
Time frame: Up to 3 months
Differences in attachment gain between laser treatment and control groups will be analyzed with a linear mixed effects model. Four sites (mesiolingual, mesiobuccal, distolingual, and distobuccal) per tooth will be averaged and used in the linear mixed effects model. Normality of the data will be assessed graphically and with the Shapiro-Wilk test.
3 secondary outcomes
Change in Gingival Bleeding Index
Time frame: Up to 3 months
Change in Plaque Index
Time frame: Up to 3 months
Change in microbial load, measured in Colony Forming Units (CFUs)
Time frame: baseline, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Charles Hawley, DDS, MS, PhD principal investigator
TUSDM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and Root Planing and Er:YAG Laser in people with Chronic Periodontitis, run by Tufts University School of Dental Medicine at 1 site in United States.
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 5 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: status not confirmed, as of the sponsor's last update on 11 Jan 2018. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Program Manager (614-636-2147, dentalresearchadministration@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Depth (time frame: Up to 3 months). 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 11 Jan 2018.