An interventional study of Trehalose Air-Polishing and Ultrasonic Instrumentation in Periodontitis, sponsored by Octavi Camps-Font. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Octavi Camps-Font · Not applicable, Interventional, and Treatment
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.
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 40 is close to the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Octavi Camps-Font is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants allocated to this group will receive supportive periodontal therapy (SPT) using an air-polishing device with low-abrasive trehalose powder for subgingival biofilm removal.
Device: Trehalose Air-Polishing
Participants allocated to this group will receive supportive periodontal therapy (SPT) using conventional ultrasonic instrumentation for subgingival biofilm and calculus removal.
Device: Ultrasonic Instrumentation
Subgingival biofilm removal during supportive periodontal therapy using an air-polishing device with low-abrasive trehalose powder.
Conventional subgingival debridement during supportive periodontal therapy using ultrasonic instrumentation.
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 session
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 session
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-up
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-up
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-up
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.
Time frame: Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.
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.
Time frame: Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.
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.
Time frame: Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.
Plaque index (PI)
Plaque will be recorded at six sites per tooth and expressed as the percentage of sites presenting plaque.
Time frame: Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.
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.
Time frame: Throughout the 24-month follow-up
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.
Time frame: Throughout the 24-month follow-up.
Plan to share: No — Individual participant data (IPD) will not be shared with external researchers, in accordance with the study protocol and applicable data protection regulations.
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Octavi Camps-Font