[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657416":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":60,"studyPopulation":50,"armGroups":61,"interventions":74,"overallOfficials":84,"centralContacts":88,"locations":94,"responsibleParty":120,"collaborators":50,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":50,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":132,"maxAge":50,"enrollmentInfo":133,"targetDuration":50,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":149,"whyStopped":50,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"University of Barcelona","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Immediately after the supportive periodontal therapy session",[14,18,22,26,30,34,37,40,43,46],{"measure":15,"description":16,"timeFrame":17},"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.","Immediately after each supportive periodontal therapy session",{"measure":19,"description":20,"timeFrame":21},"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.","At each supportive periodontal therapy visit throughout the 24-month follow-up",{"measure":23,"description":24,"timeFrame":25},"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.","Throughout the 24-month follow-up",{"measure":27,"description":28,"timeFrame":29},"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.","Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up",{"measure":31,"description":32,"timeFrame":33},"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.","Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.",{"measure":35,"description":36,"timeFrame":33},"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.",{"measure":38,"description":39,"timeFrame":33},"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.",{"measure":41,"description":42,"timeFrame":33},"Plaque index (PI)","Plaque will be recorded at six sites per tooth and expressed as the percentage of sites presenting plaque.",{"measure":44,"description":45,"timeFrame":25},"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.",{"measure":47,"description":48,"timeFrame":49},"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.","Throughout the 24-month follow-up.",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":56,"maskingDescription":57,"whoMasked":58},"SINGLE","The outcome assessor will be blinded to treatment allocation. Due to the nature of the interventions, the operator performing supportive periodontal therapy cannot be blinded.",[59],"OUTCOMES_ASSESSOR","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.\n\nConventional 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.\n\nThis 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.\n\nParticipants 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.\n\nParticipants 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.\n\nThe 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.\n\nData 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.\n\nStatistical 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.\n\nThe 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.\n\nBy 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.",[62,68],{"label":63,"type":64,"description":65,"interventionNames":66},"Trehalose Air-Polishing Group","EXPERIMENTAL","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.",[67],"Device: Trehalose Air-Polishing",{"label":69,"type":70,"description":71,"interventionNames":72},"Ultrasonic Instrumentation Group","ACTIVE_COMPARATOR","Participants allocated to this group will receive supportive periodontal therapy (SPT) using conventional ultrasonic instrumentation for subgingival biofilm and calculus removal.",[73],"Device: Ultrasonic Instrumentation",[75,80],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":50},"DEVICE","Trehalose Air-Polishing","Subgingival biofilm removal during supportive periodontal therapy using an air-polishing device with low-abrasive trehalose powder.",[63],{"type":76,"name":81,"description":82,"armGroupLabels":83,"otherNames":50},"Ultrasonic Instrumentation","Conventional subgingival debridement during supportive periodontal therapy using ultrasonic instrumentation.",[69],[85],{"name":86,"affiliation":5,"role":87},"Edgar Martínez García, DDS","PRINCIPAL_INVESTIGATOR",[89],{"name":90,"role":91,"phone":92,"phoneExt":50,"email":93},"Octavi Camps Font, DDS, MSc, PhD","CONTACT","+34 665980569","ocamps@ub.edu",[95],{"facility":96,"status":50,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"Hospital Odontològic Universitat de Barcelona","L'Hospitalet de Llobregat","Barcelona","08907","Spain","ES",{"type":103,"coordinates":104},"Point",[105,106],2.10028,41.35967,{"lat":106,"lon":105},[109,112,113,116,118],{"name":86,"role":91,"phone":110,"phoneExt":50,"email":111},"+34 689484177","emartiga248@alumnes.ub.edu",{"name":90,"role":91,"phone":92,"phoneExt":50,"email":93},{"name":114,"role":115,"phone":50,"phoneExt":50,"email":50},"Enrique Manuel Roldán Carrera, DDS, MSc","SUB_INVESTIGATOR",{"name":117,"role":115,"phone":50,"phoneExt":50,"email":50},"Albert González Barnadas, DDS, MSc, PhD",{"name":119,"role":115,"phone":50,"phoneExt":50,"email":50},"Jaume Miranda Rius, DDS, MSc, PhD",{"type":121,"investigatorFullName":122,"investigatorTitle":123,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"SPONSOR_INVESTIGATOR","Octavi Camps-Font","Associate Professor","100657416","air-polishing-for-pain-and-compliance-in-supportive-periodontal-therapy-100657416",false,"NCT07837947","Air Polishing for Pain and Compliance in Supportive Periodontal Therapy","Efficacy of Air Polishing on Pain Perception and Compliance With Supportive Periodontal Therapy: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Men or women aged 18 years or older who voluntarily agree to sign the informed consent form before any study-related procedure is performed.\n* ASA physical status I or II.\n* 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.\n* Non-smokers or light smokers (\\\u003C10 cigarettes\u002Fday).\n* Commitment to attend all follow-up visits over the 24-month study period.\n\nExclusion Criteria:\n\n* Patients requiring local anesthesia or anxiolytic premedication to undergo supportive periodontal therapy (SPT).\n* Patients with pacemakers, implantable cardioverter-defibrillators, or neurostimulators.\n* Pregnant women.\n* Patients with infectious respiratory diseases.\n* Patients with systemic diseases or neurological disorders that may alter pain perception.\n* Patients receiving medications that may influence pain perception (e.g., opioids or gabapentin).","ALL","18 Years",{"count":134,"type":135},40,"ESTIMATED","INTERVENTIONAL",[138],"NA","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.\n\nThe 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.\n\nForty 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.\n\nThe 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.\n\nThis 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.",[141],"Periodontitis",[143,144,145,146,81,147,148],"Supportive Periodontal Therapy","Periodontal Maintenance","Air Polishing","Trehalose","Pain","Patient-Reported Outcomes","NOT_YET_RECRUITING","2026-09-20",{"date":152,"type":153},"2026-09-24","ACTUAL",{"date":155,"type":135},"2026-10",{"date":157,"type":135},"2027-05",{"name":122,"class":6},1]