PeriodontitisNCT07061756
Nd:YAG Laser Effects on Subgingival Microbiota in Stage III-IV Periodontitis
A study testing SRP and ND in people with Periodontitis, run by Rui He at 1 site in China.
Trial summary
This randomized controlled trial (RCT) aims to evaluate the clinical efficacy of Nd:YAG laser adjunctive therapy and its impact on the subgingival microbiome in patients with stage III-IV periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- SRP and ND
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2024to 24 Jul 2025
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-80 years
- Minimum of 14 remaining natural teeth
- Diagnosis of Stage III-IV periodontitis according to the 2018 World Workshop classification system
- No periodontal treatment within the past 6 months
- Willing to provide informed consent and participate in the study protocol
Who cannot join
- Presence of systemic conditions that may affect periodontal treatment outcomes (e.g., uncontrolled hypertension [>140/90 mmHg], diabetes mellitus [HbA1c >7%])
- Use of antibiotics or medications known to induce gingival enlargement (e.g., calcium channel blockers, phenytoin) within the past 3 months
- Coagulation disorders or hematologic diseases
- Active systemic infections
- Pregnancy or lactation
- Acute periodontal lesions
- Inability to comply with study protocols
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Characteristics of Subgingival Microbiota in Patients With Stage III-IV Periodontitis in Response to Nd:YAG Laser-Assisted Therapy
This randomized controlled trial (RCT) aims to evaluate the clinical efficacy of Nd:YAG laser adjunctive therapy and its impact on the subgingival microbiome in patients with stage III-IV periodontitis. The study addresses two key questions: (1) Whether Nd:YAG laser combined with scaling and root planing (SRP) yields significantly greater improvements in periodontal parameters compared to SRP alone; and (2) How subgingival microbial dynamics correlate with therapeutic outcomes.
Participants were randomized into two groups: the SRP group (mechanical debridement only) and the Nd group (mechanical debridement with Nd:YAG laser therapy). Clinical parameters-including probing depth (PD), clinical attachment level (CAL), and gingival index (GI)-were assessed at baseline and 3 months post-treatment. Subgingival plaque samples were analyzed via 16S rDNA sequencing to characterize microbial community shifts.
- Conditions
- Periodontitis
- Being tested
- SRP, ND
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRPProcedure or surgery
Full-mouth scaling and root planing (SRP) was performed using an ultrasonic scaler (EMS AIR-FLOW MASTER PIEZON®) supplemented by Gracey curettes for subgingival instrumentation. All procedures were conducted under local anesthesia by a calibrated periodontist, with each quadrant treated for a minimum of 30 minutes. Patients received standardized oral hygiene instructions and were scheduled for a 3-month postoperative follow-up.
NDProcedure or surgery
In addition to the identical SRP protocol described above, adjunctive Nd:YAG laser therapy (Wiser Waterlase MD, Vista Dental) was applied immediately post-SRP. Laser parameters were set at 150 mJ/pulse, 20 Hz frequency with water (level 1) and air (level 3) coolant. The fiber optic tip (300 μm diameter) was moved in a continuous "Zig-zag" pattern along the root surface and pocket epithelium, maintaining 2-second irradiation per site at a 30° angle to the tooth axis. Standardized oral hygiene instructions and 3-month follow-up were similarly provided.
| Study group | Role | What they receive |
|---|---|---|
| Nd group | Experimental | The Nd group received comprehensive periodontal therapy combining scaling and root planing (SRP) with adjunctive Nd:YAG laser treatment. Receives: Procedure: ND |
| SRP group | Active comparator | The SRP group received standard periodontal therapy consisting of scaling and root planing (SRP) alone, serving as the active control for comparison against laser-assisted treatment. Receives: Procedure: SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha diversity of subgingival microbiota
The higher the alpha diversity, the greater the species richness and evenness of the microbial community.
Measured: From enrollment to the end of treatment at 3 months
Probing Depth
Probing depth (PD) measures the distance from the gingival margin to the base of the periodontal pocket, clinically assessing periodontal attachment loss and tissue destruction.
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (7)
Beta diversity of subgingival microbiota
Beta diversity reflects the similarity in species composition.
Measured: From enrollment to the end of treatment at 3 months
Composition of subgingival microbiota
The composition of subgingival microbiota refers to the taxonomic structure and relative abundance of bacterial species within the periodontal pocket biofilm, which plays a critical role in periodontal health and disease progression.
Measured: From enrollment to the end of treatment at 3 months
Microbial phenotypes of subgingival microbiota
The microbial phenotypes of subgingival microbiota encompass the functional and metabolic characteristics of periodontal biofilm communities, including virulence factors, antibiotic resistance profiles, and synergistic interactions that contribute to periodontal pathogenesis.
Measured: From enrollment to the end of treatment at 3 months
Clinical Attachment Level (CAL)
Clinical Attachment Level (CAL) measures the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket, directly quantifying periodontal tissue destruction and tooth-supporting structure loss.
Measured: From enrollment to the end of treatment at 3 months
Gingival Index (GI)
The Gingival Index (GI) assesses the severity of gingival inflammation through standardized scoring of redness, swelling, and bleeding tendency, providing a quantitative measure of periodontal tissue health.
Measured: From enrollment to the end of treatment at 3 months
Plaque Index (PI)
The Plaque Index (PI) quantifies the extent of bacterial plaque accumulation on tooth surfaces, using standardized scoring systems to assess oral hygiene status and periodontal disease risk.
Measured: From enrollment to the end of treatment at 3 months
Bleeding on Probing (BOP)
Bleeding on Probing (BOP) evaluates gingival inflammation by recording the presence/absence of bleeding within 30 seconds after gentle periodontal probing, serving as a key diagnostic indicator of active periodontal disease.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start28 Aug 2024
- Primary completion20 Mar 2025
- Study completion24 Jul 2025 (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.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rui He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rui He, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061756
- Sponsor's protocol ID
- [2024]493-1
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Subgingival Microbiota in Patients With Stage III-IV Periodontitis in Response to Nd:YAG Laser-Assisted Therapy
- ClinicalTrials.gov ID
- NCT07061756
- Acronym / sponsor ID
- [2024]493-1
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Rui HeUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 24 Jul 2025 (estimated)
- First posted
- 11 Jul 2025 (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.
This randomized controlled trial (RCT) aims to evaluate the clinical efficacy of Nd:YAG laser adjunctive therapy and its impact on the subgingival microbiome in patients with stage III-IV periodontitis. The study addresses two key questions: (1) Whether Nd:YAG laser combined with scaling and root planing (SRP) yields significantly greater improvements in periodontal parameters compared to SRP alone; and (2) How subgingival microbial dynamics correlate with therapeutic outcomes.
Participants were randomized into two groups: the SRP group (mechanical debridement only) and the Nd group (mechanical debridement with Nd:YAG laser therapy). Clinical parameters-including probing depth (PD), clinical attachment level (CAL), and gingival index (GI)-were assessed at baseline and 3 months post-treatment. Subgingival plaque samples were analyzed via 16S rDNA sequencing to characterize microbial community shifts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nd group | Experimental | Procedure: NDThe Nd group received comprehensive periodontal therapy combining scaling and root planing (SRP) with adjunctive Nd:YAG laser treatment. |
| SRP group | Active comparator | Procedure: SRPThe SRP group received standard periodontal therapy consisting of scaling and root planing (SRP) alone, serving as the active control for comparison against laser-assisted treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-80 years
- Minimum of 14 remaining natural teeth
- Diagnosis of Stage III-IV periodontitis according to the 2018 World Workshop classification system
- No periodontal treatment within the past 6 months
- Willing to provide informed consent and participate in the study protocol
Key exclusion criteria (7 listed)
- Presence of systemic conditions that may affect periodontal treatment outcomes (e.g., uncontrolled hypertension [>140/90 mmHg], diabetes mellitus [HbA1c >7%])
- Use of antibiotics or medications known to induce gingival enlargement (e.g., calcium channel blockers, phenytoin) within the past 3 months
- Coagulation disorders or hematologic diseases
- Active systemic infections
- Pregnancy or lactation
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 |
|---|---|---|
| SRPFull-mouth scaling and root planing (SRP) was performed using an ultrasonic scaler (EMS AIR-FLOW MASTER PIEZON®) supplemented by Gracey curettes for subgingival instrumentation. All procedures were conducted under local anesthesia by a calibrated periodontist, with each quadrant treated for a minimum of 30 minutes. Patients received standardized oral hygiene instructions and were scheduled for a 3-month postoperative follow-up. | Procedure or surgery | SRP group |
| NDIn addition to the identical SRP protocol described above, adjunctive Nd:YAG laser therapy (Wiser Waterlase MD, Vista Dental) was applied immediately post-SRP. Laser parameters were set at 150 mJ/pulse, 20 Hz frequency with water (level 1) and air (level 3) coolant. The fiber optic tip (300 μm diameter) was moved in a continuous "Zig-zag" pattern along the root surface and pocket epithelium, maintaining 2-second irradiation per site at a 30° angle to the tooth axis. Standardized oral hygiene instructions and 3-month follow-up were similarly provided. | Procedure or surgery | Nd group |
Primary outcome
Alpha diversity of subgingival microbiota
Time frame: From enrollment to the end of treatment at 3 months
The higher the alpha diversity, the greater the species richness and evenness of the microbial community.
Probing Depth
Time frame: From enrollment to the end of treatment at 3 months
Probing depth (PD) measures the distance from the gingival margin to the base of the periodontal pocket, clinically assessing periodontal attachment loss and tissue destruction.
7 secondary outcomes
Beta diversity of subgingival microbiota
Time frame: From enrollment to the end of treatment at 3 months
Composition of subgingival microbiota
Time frame: From enrollment to the end of treatment at 3 months
Microbial phenotypes of subgingival microbiota
Time frame: From enrollment to the end of treatment at 3 months
Clinical Attachment Level (CAL)
Time frame: From enrollment to the end of treatment at 3 months
Gingival Index (GI)
Time frame: From enrollment to the end of treatment at 3 months
Plaque Index (PI)
Time frame: From enrollment to the end of treatment at 3 months
Bleeding on Probing (BOP)
Time frame: From enrollment to the end of treatment at 3 months
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 11 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRP and ND in people with Periodontitis, run by Rui He 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 11 Jul 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. 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?
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?
Alpha diversity of subgingival microbiota (time frame: From enrollment to the end of treatment at 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 Jul 2025.