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PeriodontitisNCT07837947

Air Polishing for Pain and Compliance in Supportive Periodontal Therapy

A study testing Trehalose Air-Polishing and Ultrasonic Instrumentation in people with Periodontitis, run by Octavi Camps-Font at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Supportive periodontal therapy (SPT) is essential for maintaining periodontal stability and preventing disease recurrence in patients who have been successfully treated for periodontitis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Periodontitis
What is being tested?
Trehalose Air-Polishing and Ultrasonic Instrumentation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSpain
Study dates
Oct 2026to May 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women aged 18 years or older who voluntarily agree to sign the informed consent form before any study-related procedure is performed.
  • ASA physical status I or II.
  • Initial diagnosis of Stage I-III periodontitis according to the 2017 World Workshop, periodontally treated and stabilized, and enrolled in a supportive periodontal therapy (SPT) program.
  • Non-smokers or light smokers (<10 cigarettes/day).
  • Commitment to attend all follow-up visits over the 24-month study period.

Who cannot join

  • Patients requiring local anesthesia or anxiolytic premedication to undergo supportive periodontal therapy (SPT).
  • Patients with pacemakers, implantable cardioverter-defibrillators, or neurostimulators.
  • Pregnant women.
  • Patients with infectious respiratory diseases.
  • Patients with systemic diseases or neurological disorders that may alter pain perception.
  • Patients receiving medications that may influence pain perception (e.g., opioids or gabapentin).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Octavi Camps Font, DDS, MSc, PhD contact

+34 665980569

ocamps@ub.edu

Spain1 site
  • Hospital Odontològic Universitat de Barcelona

    L'Hospitalet de Llobregat, Barcelona, 08907

    Edgar Martínez García, DDS, +34 689484177, emartiga248@alumnes.ub.edu

    Octavi Camps Font, DDS, MSc, PhD, +34 665980569, ocamps@ub.edu

Other trials in Spain

About this study

Official title: Efficacy of Air Polishing on Pain Perception and Compliance With Supportive Periodontal Therapy: A Randomized Clinical Trial

Supportive periodontal therapy (SPT) is essential for maintaining periodontal stability and preventing disease recurrence in patients who have been successfully treated for periodontitis. However, long-term effectiveness depends on regular attendance at maintenance visits, and negative experiences associated with periodontal instrumentation, such as pain or discomfort, may affect patient acceptance and adherence to the maintenance program.

The aim of this randomized clinical trial is to evaluate whether supportive periodontal therapy performed using an air-polishing device with low-abrasive trehalose powder reduces patient-perceived pain and improves the clinical experience compared with conventional biofilm removal using ultrasonic instrumentation. The study will also assess whether the use of air polishing is associated with better adherence to the periodontal maintenance program while maintaining comparable periodontal clinical outcomes.

Read more

Forty periodontally stabilized adult patients enrolled in the supportive periodontal therapy program of the Master's Degree in Periodontology and Peri-implantology at the University of Barcelona will be randomly allocated in a 1:1 ratio to one of two parallel treatment groups. The control group will receive conventional supportive periodontal therapy using ultrasonic instrumentation, while the experimental group will receive supportive periodontal therapy using an air-polishing device with low-abrasive trehalose powder. Participants will be followed for 24 months.

The primary outcome will be patient-perceived pain associated with supportive periodontal therapy, assessed using a visual analogue scale (VAS). Secondary outcomes will include treatment duration, adherence to scheduled maintenance visits, patient experience and acceptance of treatment, and periodontal clinical parameters. Periodontal status will be monitored throughout follow-up by assessing probing pocket depth, clinical attachment level, bleeding on probing, and plaque index.

This study aims to determine whether air polishing with trehalose powder can provide a more comfortable and patient-centered approach to supportive periodontal therapy without compromising periodontal clinical outcomes, and whether an improved treatment experience may contribute to better long-term adherence to periodontal maintenance.

Read the detailed description

Periodontitis is a chronic inflammatory disease that requires long-term supportive periodontal therapy (SPT) after completion of active periodontal treatment in order to maintain periodontal stability and reduce the risk of disease recurrence. The effectiveness of SPT is strongly influenced by long-term patient adherence. Therefore, improving patient comfort and treatment experience during maintenance visits may contribute to better adherence to periodontal maintenance programs.

Conventional SPT commonly involves mechanical removal of supra- and subgingival biofilm and deposits using ultrasonic instrumentation. Air-polishing devices using low-abrasive powders have been proposed as an alternative approach for biofilm removal during periodontal maintenance. Previous studies suggest that air polishing may provide effective biofilm removal while reducing patient discomfort and treatment time. However, evidence regarding the use of newer-generation air-polishing systems with trehalose-based powder during SPT remains limited. This study will therefore evaluate both patient-reported outcomes and periodontal clinical outcomes associated with this approach.

This study is designed as a randomized, superiority, parallel-group clinical trial with a 24-month follow-up period. A total of 40 periodontally stabilized adult patients enrolled in the SPT program of the Master's Degree in Periodontology and Peri-implantology at the University of Barcelona will be included. Participants who meet the eligibility criteria and provide written informed consent will be randomly allocated in a 1:1 ratio to either the experimental group or the control group, with an expected sample of 20 participants per group.

Participants allocated to the control group will receive conventional biofilm removal using ultrasonic instrumentation during supportive periodontal therapy. Participants allocated to the experimental group will receive supportive periodontal therapy using an air-polishing device with low-abrasive trehalose powder. The purpose of this comparison is to determine whether the air-polishing approach reduces patient-perceived pain and improves the overall treatment experience and adherence to the maintenance program compared with conventional ultrasonic instrumentation, while maintaining comparable periodontal clinical outcomes.

Participants will be prospectively evaluated at baseline and during follow-up visits over a period of 24 months. Maintenance visits will be performed every 6 months. At each maintenance visit, a complete periodontal examination will be performed. Periodontal clinical parameters will include probing pocket depth, clinical attachment level, bleeding on probing, and plaque index.

The primary outcome of the study will be patient-perceived pain associated with supportive periodontal therapy. Immediately after treatment, perceived pain will be assessed using a visual analogue scale (VAS). Secondary outcomes will include patient experience, adherence to the periodontal maintenance program, treatment duration, and periodontal clinical outcomes. Adherence will be evaluated according to attendance at scheduled maintenance visits throughout the follow-up period.

Data will be prospectively collected using a specific electronic data collection form, including demographic and clinical variables as well as patient-experience questionnaires. Investigators responsible for clinical examinations will undergo calibration before participant recruitment.

Statistical analyses will be conducted according to the intention-to-treat principle, with patient-perceived pain considered the primary outcome variable. The study is designed to determine whether the use of air polishing with trehalose powder provides a superior patient experience, particularly in terms of perceived pain, compared with conventional ultrasonic instrumentation, while also assessing whether both approaches provide comparable periodontal clinical outcomes over time.

The study will be conducted at the University of Barcelona Dental Hospital (Hospital Odontològic Universitat de Barcelona), in the clinical facilities of the Master's Degree in Periodontology and Peri-implantology. Recruitment, diagnosis, and treatment of participants will be performed by residents of the Master's program under the supervision of the study investigators.

By simultaneously evaluating patient-reported outcomes, adherence, treatment efficiency, and periodontal clinical parameters, this study seeks to determine whether air polishing with trehalose powder may represent a more comfortable and patient-centered approach to supportive periodontal therapy without compromising periodontal stability. If improved comfort is associated with better adherence to scheduled maintenance visits, this approach could contribute to optimizing long-term periodontal maintenance protocols.

Conditions
Periodontitis
Being tested
Trehalose Air-Polishing, Ultrasonic Instrumentation
Keywords
Supportive Periodontal Therapy, Periodontal Maintenance, Air Polishing, Trehalose, Ultrasonic Instrumentation, Pain, Patient-Reported Outcomes
Medical subject headings
Periodontitis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trehalose Air-PolishingDevice

    Subgingival biofilm removal during supportive periodontal therapy using an air-polishing device with low-abrasive trehalose powder.

  • Ultrasonic InstrumentationDevice

    Conventional subgingival debridement during supportive periodontal therapy using ultrasonic instrumentation.

Study groups in NCT07837947
Study groupRoleWhat they receive
Trehalose Air-Polishing GroupExperimentalParticipants allocated to this group will receive supportive periodontal therapy (SPT) using an air-polishing device with low-abrasive trehalose powder for subgingival biofilm removal.
Receives: Device: Trehalose Air-Polishing
Ultrasonic Instrumentation GroupActive comparatorParticipants allocated to this group will receive supportive periodontal therapy (SPT) using conventional ultrasonic instrumentation for subgingival biofilm and calculus removal.
Receives: Device: Ultrasonic Instrumentation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain perceived during supportive periodontal therapy

    Pain perceived by the participant during the supportive periodontal therapy session will be assessed using a Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). The outcome will be compared between participants treated with trehalose air-polishing and those treated with ultrasonic instrumentation.

    Measured: Immediately after the supportive periodontal therapy session

Secondary outcomes (10)
  1. Patient-reported treatment experience

    Patient-reported experience with supportive periodontal therapy will be assessed using a structured questionnaire after treatment. The questionnaire will evaluate aspects related to comfort, treatment perception, satisfaction, and preference, allowing comparison between trehalose air-polishing and ultrasonic instrumentation.

    Measured: Immediately after each supportive periodontal therapy session

  2. Duration of supportive periodontal therapy session

    Duration of the supportive periodontal therapy session, measured in minutes from the effective start of the clinical procedure until completion of the periodontal treatment scheduled for that visit.

    Measured: At each supportive periodontal therapy visit throughout the 24-month follow-up

  3. Adherence to supportive periodontal therapy

    Adherence to the supportive periodontal therapy program will be assessed based on attendance at scheduled maintenance visits. Adherence will be determined from the proportion of scheduled visits attended by each participant during the follow-up period.

    Measured: Throughout the 24-month follow-up

  4. Probing pocket depth (PPD)

    Probing pocket depth will be measured at six sites per tooth using a UNC-15 periodontal probe and expressed in millimeters.

    Measured: Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up

  5. Clinical attachment level (CAL)

    Clinical attachment level will be measured at six sites per tooth using a UNC-15 periodontal probe and expressed in millimeters.

    Measured: Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.

  6. Gingival margin position (MG)

    Gingival margin position will be measured at six sites per tooth using a UNC-15 periodontal probe and expressed in millimeters.

    Measured: Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.

  7. Bleeding on probin (BoP)

    Bleeding on probing will be recorded at six sites per tooth and expressed as the percentage of sites presenting bleeding after periodontal probing.

    Measured: Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.

  8. Plaque index (PI)

    Plaque will be recorded at six sites per tooth and expressed as the percentage of sites presenting plaque.

    Measured: Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.

  9. Patient knowledge and awareness of supportive periodontal therapy

    Patient knowledge and awareness regarding periodontitis and the importance of supportive periodontal therapy will be assessed using an 8-item questionnaire. Each correct response will receive 1 point and each incorrect response 0 points, resulting in a total score ranging from 0 to 8. Higher scores indicate greater knowledge and awareness of periodontitis and supportive periodontal therapy.

    Measured: Throughout the 24-month follow-up

  10. Patient-reported perceived knowledge of periodontal disease and supportive periodontal therapy

    Participants will rate their perceived level of knowledge regarding their periodontal disease and supportive periodontal therapy on a numerical rating scale ranging from 1 to 10, with higher scores indicating a greater self-perceived level of knowledge.

    Measured: Throughout the 24-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07837947
Sponsor's protocol ID
33/2026
Status last verified
Sep 2026
First submitted
12 Sep 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared with external researchers, in accordance with the study protocol and applicable data protection regulations.

Questions about this trial

What is this clinical trial studying?

A study testing Trehalose Air-Polishing and Ultrasonic Instrumentation in people with Periodontitis, run by Octavi Camps-Font at 1 site in Spain.

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 6 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: opening soon, as of the sponsor's last update on 24 Sep 2026. 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 Spain. 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 Octavi Camps Font, DDS, MSc, PhD (+34 665980569, ocamps@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain perceived during supportive periodontal therapy (time frame: Immediately after the supportive periodontal therapy session). 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 24 Sep 2026.

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