PeriodontitisNCT06574802
Er:YAG Laser and Air Polishing Application in Periodontal Treatment
A study testing ERL + air polishing and ERL in people with Periodontitis, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- ERL + air polishing and ERL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020
Xuan Zhou, Dr.
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- ERL + air polishing, ERL
- Keywords
- generalized, stage Ⅱ or stage Ⅲ
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERL + air polishingProcedure or surgery
Er:YAG laser (ERL) plus sub-gingival air polishing treatment
ERLProcedure or surgery
ERL treatment
| Study group | Role | What they receive |
|---|---|---|
| test group | Active comparator | Er:YAG laser (ERL) plus sub-gingival air polishing treatment Receives: Procedure: ERL + air polishing |
| control group | Placebo comparator | ERL treatment only Receives: Procedure: ERL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PD
Changes in probing depth (PD) measured using periodontal probing
Measured: at 3 months, 6 months, 1 year, and 2 years
Changes in CAL
Changes in clinical attachment level (CAL) measured using periodontal probing
Measured: at 3 months, 6 months, 1 year, and 2 years
Secondary outcomes (2)
changes in BI
Changes in bleeding index (BI) measured using periodontal probing
Measured: at 3 months, 6 months, 1 year, and 2 years
PLI
Plaque index (PLI) assessed by an examiner using a scale of 0 to 3
Measured: at 3 months, 6 months, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start4 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GuangXu Liu, Doctor, Principal investigator, Research Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574802
- Sponsor's protocol ID
- CYFH202207
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Application of Er:YAG Laser and Sub-gingival Air Polishing Powder in Treatment of Periodontitis: A Split-mouth, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06574802
- Acronym / sponsor ID
- CYFH202207
- Conditions
- Periodontitis
- Keywords
- generalized, stage Ⅱ or stage Ⅲ
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Aug 2024 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Active comparator | Procedure: ERL + air polishingEr:YAG laser (ERL) plus sub-gingival air polishing treatment |
| control group | Placebo comparator | Procedure: ERLERL treatment only |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| ERL + air polishingEr:YAG laser (ERL) plus sub-gingival air polishing treatment | Procedure or surgery | test group |
| ERLERL treatment | Procedure or surgery | control group |
Primary outcome
Changes in PD
Time frame: at 3 months, 6 months, 1 year, and 2 years
Changes in probing depth (PD) measured using periodontal probing
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
2 secondary outcomes
changes in BI
Time frame: at 3 months, 6 months, 1 year, and 2 years
PLI
Time frame: at 3 months, 6 months, 1 year, and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
GuangXu Liu, Doctor principal investigator
Research Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERL + air polishing and ERL in people with Periodontitis, run by Beijing Chao Yang Hospital at 1 site in China.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. 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 China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuan Zhou, Doctor (86-10-85231344, xuanzhou@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PD (time frame: at 3 months, 6 months, 1 year, and 2 years). 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 7 Feb 2025.