Generalized Moderate Chronic PeriodontitisNCT03628872
Treatment of Periodontitis With Er:YAG Laser
A study testing Scaling and root planing, Er:YAG Laser and Hand instruments in people with Generalized Moderate Chronic Periodontitis and Generalized Severe Chronic Periodontitis, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this research project is to gain information on the best and most comfortable way to treat the periodontal disease. The main objective is to compare the efficacy of conventional scaling and root planning compared to laser scaling for the non-surgical treatment of periodontal disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Generalized Moderate Chronic Periodontitis, Generalized Severe Chronic Periodontitis, Periodontal Diseases
- What is being tested?
- Scaling and root planing, Er:YAG Laser and Hand instruments
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2018to 1 Jun 2019
- Phase
- Interventional
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
- Signed and dated Informed Consent
- Good general health
- Participants > 18 years of age
- Participants with > 20 teeth with 5 teeth, including at least 1 molar, in each quadrant of the mouth
- Participants with > 30% of the present teeth with Probing depths of > 4mm and Bleeding on Probing
- Non-smoker and former smokers (stopped smoking > 1 year)
- Participants that have not received any periodontal treatment in the past 3 months
Who cannot join
- Participants with uncontrolled systemic diseases that could affect the treatment outcome such as Diabetes with HbA1c > 7.0 percent, rheumatoid arthritis, immunosuppression, HIV with detectable viral loads
- Participants requiring antibiotic prophylaxis for any cardiovascular conditions or after any transplant and/or replacement procedures
- Pregnant women
- Patients treated with systemic antibiotic therapy of periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration
- Patients being chronically (two weeks or more) treated with any NSAIDs, steroids or any medications known to affect soft tissue condition (excluding treatment with Acetylsalicylic acid < 100 mg/day)
- Presence of orthodontic appliances, or any removable appliances that impinges on the tissues being assessed.
- Presence of soft or hard tissue tumors of the oral cavity
- The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University College of Dental Medicine
New York, New York, 10032
About this study
Official title: Treatment of Periodontitis Utilizing Two Different Modalities: Erbium-doped Yttrium Aluminium Garnet (Er:YAG) Laser and Conventional Mechanical Debridement
The purpose of this research project is to gain information on the best and most comfortable way to treat the periodontal disease. The main objective is to compare the efficacy of conventional scaling and root planning compared to laser scaling for the non-surgical treatment of periodontal disease. Both therapies have shown to be effective and are regularly used in the dental clinic.
Read the detailed description
The study has been designed as a single blinded split-mouth randomized controlled clinical trial. Patients will be randomized prior to treatment, to which the examiner will be blinded. Clinical parameters will be recorded at baseline and 3 months after treatment has been completed. At the time of recruitment, inclusion/exclusion criteria checklist, informed consent and baseline measurements will be obtained and recorded. Medical history will be updated and radiographs will be reviewed or taken. During the second appointment, conventional scaling and root planing will be performed in the corresponding quadrant; during the third appointment, laser therapy will be conducted, 1 month after, during the forth appointment, a follow up (no measurements) will be scheduled with provider, and 3 months after scaling completion, measurements will be taken and periodontal maintenance performed. Patient will receive home care instructions at every visit and will fill out a visual analogue scale at baseline, 1 month and 3 month visit.
- Conditions
- Generalized Moderate Chronic Periodontitis, Generalized Severe Chronic Periodontitis, Periodontal Diseases
- Being tested
- Scaling and root planing, Er:YAG Laser, Hand instruments
- Keywords
- Scaling and root planing, Laser scaling
- Medical subject headings
- Periodontal Diseases
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
Also called Deep cleaning
A non-surgical procedure that treats periodontal disease, sometimes called a deep cleaning, is considered the "gold standard" (standard of care) of treatment for patients with chronic periodontitis.
Er:YAG LaserDevice
Also called Erbium-doped Yttrium Aluminium Garnet Laser
This laser is intended to be used for dental surgery. The Er:YAG Laser emits an infrared beam which is readily absorbed by water contained by both hard and soft tissues of the human body. As a result, energy of the laser beam instantly vaporizes the water molecules in soft and hard tissues of the tooth and surrounding tissues causing the tissues to crumble away or resection of the soft tissues of gingival.
Hand instrumentsDevice
Also called Hand instrumentation
11/12 and 13/14 gracey, 4R/4L curette and sickle - standard of care choices for performing scaling and root planing.
| Study group | Role | What they receive |
|---|---|---|
| Scaling and Root Planing with Hand Instruments | Active comparator | Patients will undergo scaling and root planing with hand instruments (half of their mouth, following a split-mouth design) Receives: Procedure: Scaling and root planing; Device: Hand instruments |
| Er:YAG Laser Scaling | Experimental | Patients will undergo scaling and root planing with Er:YAG Laser in the untreated half of their mouth. 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 Clinical Attachment Level (CAL)
Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement)
Measured: 3 months after treatment
Change in Pocket Depth (PD)
Measured at 6 sites per tooth in millimeters (mm) (site specific measurement). The mean value of the measurements was obtained for both treatment groups by averaging all teeth for each quadrant.
Measured: 3 months after treatment
Secondary outcomes (5)
Plaque Index (PI)
Plaque and calculus accumulation on tooth surfaces (site specific measurement). Plaque Index is calculated by [number of sites with plaque] divided by [number of sites evaluated], multiplied by 100 (represented as a percent).
Measured: 3 months after treatment
Bleeding on Probing (BoP)
Bleeding after probing the pocket (site specific measurement). BoP is calculated by: [number of bleeding sites] divided by [number of sites evaluated], multiplied by 100 (represented as a percent).
Measured: 3 months after treatment
Average Duration of Treatment
Comparison of duration of treatment between the 2 modalities
Measured: Time between the start of treatment to treatment completion, up to 180 minutes
Number of Participants Who Preferred Modality
Participants were given 2 multiple choice questions to assess their modality of preference and the reasoning behind it.
Measured: 3 months after treatment
Number of Patients Who Experienced a Better Improvement in Sensitivity
A numeric scale was completed by participants to assess their degree of sensitivity or pain with a modified 0 - 10 scale (i.e.: 0- no pain/sensitivity; 5- moderate pain or sensitivity, may require medication; 10- unbearable sensitivity or pain that impairs my sleep). Baseline and 3 months reported scores were compared within each patient and between modalities. The numbers reported are participants that experienced a better improvement in sensitivity within the respective modality.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start2 Mar 2018
- Primary completion1 May 2019
- Study completion1 Jun 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 Generalized Moderate Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Y. Kang, Columbia University
- Investigators
- Philip Kang, DDS, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628872
- Sponsor's protocol ID
- AAAR6077
- Status last verified
- Nov 2024
- First submitted
- 8 Aug 2018
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No