Air Polishing for Pain and Compliance in Supportive Periodontal Therapy
ConditionPeriodontitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOctavi Camps-Font
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Trehalose Air-Polishing
DeviceSubgingival biofilm removal during supportive periodontal therapy using an air-polishing device with low-abrasive trehalose powder.
Ultrasonic Instrumentation
DeviceConventional subgingival debridement during supportive periodontal therapy using ultrasonic instrumentation.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Trehalose Air-Polishing GroupExperimental treatment 1 intervention
Group B: Ultrasonic Instrumentation GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Immediately after the supportive periodontal therapy sessionSecondary outcomes
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.
Time frame
Immediately after each supportive periodontal therapy session2
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.
Time frame
At each supportive periodontal therapy visit throughout the 24-month follow-up3
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.
Time frame
Throughout the 24-month follow-up4
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.
Time frame
Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Octavi Camps-Font
Lead sponsor
University of Barcelona
Sponsor institution
Source ClinicalTrials.gov
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