- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06574802
Er:YAG Laser and Air Polishing Application in Periodontal Treatment
February 5, 2025 updated by: Beijing Chao Yang Hospital
Combined Application of Er:YAG Laser and Sub-gingival Air Polishing Powder in Treatment of Periodontitis: A Split-mouth, Randomized Controlled Trial
Periodontitis (gum disease) is an infection of the gums that can lead to tooth loss.
In recent years, many types of dental lasers or other devices have been used for the non-surgical treatment of periodontal diseases.
However, it remains unclear whether the combined application of laser and air polishing is effective as an adjuvant treatment for periodontitis.
The purpose of this study is to compare the use of combined application of Er:YAG laser and sub-gingival air polishing powder, with the treatment of Er:YAG laser only, in periodontal diseases treatment in a Chinese population.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study will use a split-mouth design, two quadrants (one quadrant from each jaw) were randomly allocated to either the test or control group.
The quadrants in the test group received Er:YAG laser (ERL) plus sub-gingival air polishing treatment, while the quadrants in the control group received ERL only.
Clinical periodontal examinations were evaluated at baseline, 3 months, 6 months, 1 year, and 2 years.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xuan Zhou, Doctor
- Phone Number: 86-10-85231344
- Email: xuanzhou@sina.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100020
- Recruiting
- Beijing Chao Yang Hospital
-
Contact:
- Xuan Zhou, Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 1) aged 35-65 years old, in good systemic healthy;
- 2) clinically diagnosed with generalized stage Ⅱ or stage Ⅲ periodontitis;
- 3) a minimum of 20 teeth
Exclusion Criteria:
- 1) pregnancy or recent pregnancy plans;
- 2) had received periodontal treatment within the previous 6 months;
- 3) taken antibiotics within the previous 3 months;
- 4) had diabetes;
- 5) obvious malocclusion, history of orthodontic treatment, or a habit of mouth breathing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: test group
Er:YAG laser (ERL) plus sub-gingival air polishing treatment
|
Er:YAG laser (ERL) plus sub-gingival air polishing treatment
|
|
Placebo Comparator: control group
ERL treatment only
|
ERL treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in PD
Time Frame: at 3 months, 6 months, 1 year, and 2 years
|
Changes in probing depth (PD) measured using periodontal probing
|
at 3 months, 6 months, 1 year, and 2 years
|
|
Changes in CAL
Time Frame: at 3 months, 6 months, 1 year, and 2 years
|
Changes in clinical attachment level (CAL) measured using periodontal probing
|
at 3 months, 6 months, 1 year, and 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in BI
Time Frame: at 3 months, 6 months, 1 year, and 2 years
|
Changes in bleeding index (BI) measured using periodontal probing
|
at 3 months, 6 months, 1 year, and 2 years
|
|
PLI
Time Frame: at 3 months, 6 months, 1 year, and 2 years
|
Plaque index (PLI) assessed by an examiner using a scale of 0 to 3
|
at 3 months, 6 months, 1 year, and 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: GuangXu Liu, Doctor, Research Department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 4, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
August 26, 2024
First Submitted That Met QC Criteria
August 26, 2024
First Posted (Actual)
August 28, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 5, 2025
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CYFH202207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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