Chronic Apical PeriodontitisNCT07069881
Sonic vs Passive Ultrasonic Irrigation for Chronic Apical Periodontitis
A study testing Sonic-Activated Irrigation and Passive Ultrasonic Irrigation in people with Chronic Apical Periodontitis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This randomized, controlled, double-blinded clinical trial aims to directly compare the efficacy of Sonically Activated Irrigation (SAI) versus Passive Ultrasonic Irrigation (PUI) in the root canal treatment of teeth with chronic apical periodontitis, analyze potential influencing factors, and thereby identify a… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Chronic Apical Periodontitis
- What is being tested?
- Sonic-Activated Irrigation and Passive Ultrasonic Irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 31 Dec 2026
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Agree to participate in this study and provide informed consent;
- Age 18-59 years at the time of enrolment;
- At least one permanent tooth diagnosed with chronic periapical periodontitis at root development stage of Nolla10th;
- Able to follow up on schedule.
Who cannot join
- Allergies to any medications or materials necessary to complete the procedures;
- Non-restorable teeth, teeth with severe defects, or teeth that need to be extracted due to orthodontic treatment;
- Teeth with root canal treatment or vital pulp therapy;
- Teeth with canal calcification or root canal instrument separation;
- Teeth with root fracture or vertical root fracture;
- Tooth with internal or external root resorption;
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- Patients with periodontitis;
- Patients with orthodontic treatment;
- Presence of dental phobia;
- Women who are pregnant;
- Patients who have taken medications that affect central nervous system, such as tricyclic antidepressant;
- Patients who have taken medications that affect immune response, such as glucocorticoid or cyclosporin;
- Patients after radiotherapy of tumor head and neck;
- Patients who have taken medications that affect curative effect, such as bisphosphonates;
- Patients with serious systemic diseases that can affect curative effect;
- Participation in other clinical studies within the past several weeks;
- Patients who are deemed unsuitable to participate in the study by investigators.
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
Southern Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: A Randomized Controlled Trial of Endodontic Treatment Using Sonic-activated Irrigation and Passive Ultrasonic Irrigation to Evaluate Healing in Chronic Apical Periodontitis
This randomized, controlled, double-blinded clinical trial aims to directly compare the efficacy of Sonically Activated Irrigation (SAI) versus Passive Ultrasonic Irrigation (PUI) in the root canal treatment of teeth with chronic apical periodontitis, analyze potential influencing factors, and thereby identify a highly effective and safe root canal irrigation protocol. The ultimate goal is to provide an evidence-based rationale for optimizing irrigation technique selection and overall treatment strategies for chronic apical periodontitis.
Read the detailed description
Root canal therapy (RCT) is the common treatment for chronic apical periodontitis. Successful outcomes critically depend on the complete eradication of infection within the root canal system. The efficacy of infection control is significantly influenced by the irrigation technique employed. While passive ultrasonic irrigation (PUI) is a widely utilized form of activated irrigation in clinical practice, it carries inherent risks such as instrument separation and unnecessary dentin removal, limiting its use.
Sonically activated irrigation (SAI) represents a novel irrigation approach. Its polymeric tips circumvent the drawbacks associated with ultrasonic metal tips while delivering comparable irrigation efficiency. However, high-quality randomized controlled clinical evidence supporting its use is currently lacking.
This randomized, controlled, double-blinded clinical trial aims to directly compare the efficacy of SAI versus PUI in root canal treatment of teeth with chronic apical periodontitis and analyze potential influencing factors. The goal is to identify a highly effective and safe root canal irrigation protocol, ultimately providing an evidence-based rationale for optimizing irrigation technique selection and overall treatment strategies for chronic apical periodontitis.
- Conditions
- Chronic Apical Periodontitis
- Being tested
- Sonic-Activated Irrigation, Passive Ultrasonic Irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonic-Activated IrrigationDevice
Sonic-activated irrigation was performed using the polymer tip (Eddy™, VDW, Germany) activated by an airscaler handpiece.
Passive Ultrasonic IrrigationDevice
Passive ultrasonic irrigation was performed using the ultrasonic tip (ACTEON, France) attached to an ultrasonic device (P5 Newton™, ACTEON, France)
| Study group | Role | What they receive |
|---|---|---|
| Sonic-Activated Irrigation | Experimental | Not described Receives: Device: Sonic-Activated Irrigation |
| Passive Ultrasonic Irrigation | Active comparator | Not described Receives: Device: Passive Ultrasonic Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Effect Evaluation
- Success: A tooth is considered successfully treated when it is asymptomatic, showing no signs of apical infection such as percussion pain, mobility (loosening), tenderness, mucosal swelling, sinus tract, or fistula. Radiographically, the periapical radiolucency must demonstrate either absence or significant reduction.
- Failure: Treatment is deemed unsuccessful if the tooth remains symptomatic or develops new symptoms of apical infection (e.g., pain, fistula). Radiographically, the size of the periapical radiolucency remains unchanged or shows enlargement.
Measured: 12 months after treatment
Secondary outcomes (3)
postoperative pain
Postoperative pain was assessed using the Visual Analogue Scale (VAS) during clinical follow-up on day 1 after treatment.
Measured: day 1 after treatment
Cone Beam Computed Tomography Periapical Index Scores (CBCTPAI)
The CBCT Periapical Index (CBCTPAI) assigns scores to lesions of chronic apical periodontitis based on the largest dimension measured in three planes (buccopalatal, mesiodistal, diagonal) on CBCT scans.
0： Intact periapical bone structures；
- Diameter of periapical radiolucency > 0.5-1 mm；
- Diameter of periapical radiolucency > 1-2 mm；
- Diameter of periapical radiolucency > 2-4 mm；
- Diameter of periapical radiolucency > 4-8 mm；
- Diameter of periapical radiolucency > 8 mm； Score (n) + E： Expansion of periapical cortical bone； Score (n) + D ： Destruction of periapical cortical bone.
Measured: 12 months after treatment
The size of the periapical lesion
The size in periapical lesions were quantified using cone beam computed tomography (CBCT) at 1-year postoperative compared to preoperative baseline across three anatomical planes: buccopalatal, mesiodistal, and diagonal.
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start30 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069881
- Sponsor's protocol ID
- NFEC-2024-435
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Endodontic Treatment Using Sonic-activated Irrigation and Passive Ultrasonic Irrigation to Evaluate Healing in Chronic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07069881
- Acronym / sponsor ID
- NFEC-2024-435
- Conditions
- Chronic Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 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, double-blinded clinical trial aims to directly compare the efficacy of Sonically Activated Irrigation (SAI) versus Passive Ultrasonic Irrigation (PUI) in the root canal treatment of teeth with chronic apical periodontitis, analyze potential influencing factors, and thereby identify a highly effective and safe root canal irrigation protocol. The ultimate goal is to provide an evidence-based rationale for optimizing irrigation technique selection and overall treatment strategies for chronic apical periodontitis.
Detailed description
Root canal therapy (RCT) is the common treatment for chronic apical periodontitis. Successful outcomes critically depend on the complete eradication of infection within the root canal system. The efficacy of infection control is significantly influenced by the irrigation technique employed. While passive ultrasonic irrigation (PUI) is a widely utilized form of activated irrigation in clinical practice, it carries inherent risks such as instrument separation and unnecessary dentin removal, limiting its use.
Sonically activated irrigation (SAI) represents a novel irrigation approach. Its polymeric tips circumvent the drawbacks associated with ultrasonic metal tips while delivering comparable irrigation efficiency. However, high-quality randomized controlled clinical evidence supporting its use is currently lacking.
This randomized, controlled, double-blinded clinical trial aims to directly compare the efficacy of SAI versus PUI in root canal treatment of teeth with chronic apical periodontitis and analyze potential influencing factors. The goal is to identify a highly effective and safe root canal irrigation protocol, ultimately providing an evidence-based rationale for optimizing irrigation technique selection and overall treatment strategies for chronic apical periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonic-Activated Irrigation | Experimental | Device: Sonic-Activated Irrigation |
| Passive Ultrasonic Irrigation | Active comparator | Device: Passive Ultrasonic Irrigation |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Agree to participate in this study and provide informed consent;
- Age 18-59 years at the time of enrolment;
- At least one permanent tooth diagnosed with chronic periapical periodontitis at root development stage of Nolla10th;
- Able to follow up on schedule.
Key exclusion criteria (17 listed)
- Allergies to any medications or materials necessary to complete the procedures;
- Non-restorable teeth, teeth with severe defects, or teeth that need to be extracted due to orthodontic treatment;
- Teeth with root canal treatment or vital pulp therapy;
- Teeth with canal calcification or root canal instrument separation;
- Teeth with root fracture or vertical root fracture;
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 |
|---|---|---|
| Sonic-Activated IrrigationSonic-activated irrigation was performed using the polymer tip (Eddy™, VDW, Germany) activated by an airscaler handpiece. | Device | Sonic-Activated Irrigation |
| Passive Ultrasonic IrrigationPassive ultrasonic irrigation was performed using the ultrasonic tip (ACTEON, France) attached to an ultrasonic device (P5 Newton™, ACTEON, France) | Device | Passive Ultrasonic Irrigation |
Primary outcome
Therapeutic Effect Evaluation
Time frame: 12 months after treatment
1. Success: A tooth is considered successfully treated when it is asymptomatic, showing no signs of apical infection such as percussion pain, mobility (loosening), tenderness, mucosal swelling, sinus tract, or fistula. Radiographically, the periapical radiolucency must demonstrate either absence or significant reduction. 2. Failure: Treatment is deemed unsuccessful if the tooth remains symptomatic or develops new symptoms of apical infection (e.g., pain, fistula). Radiographically, the size of the periapical radiolucency remains unchanged or shows enlargement.
3 secondary outcomes
postoperative pain
Time frame: day 1 after treatment
Cone Beam Computed Tomography Periapical Index Scores (CBCTPAI)
Time frame: 12 months after treatment
The size of the periapical lesion
Time frame: 12 months after treatment
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 17 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonic-Activated Irrigation and Passive Ultrasonic Irrigation in people with Chronic Apical Periodontitis, run by Nanfang Hospital, Southern Medical University 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 4 inclusion and 17 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 17 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?
Contact Liang Yuee (0086-020-62787149, yueeliang734@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic Effect Evaluation (time frame: 12 months after treatment). 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 17 Jul 2025.