protocolSection identificationModule nctId: NCT06315348, orgStudyIdInfo id: URI_116301123, briefTitle: Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment, acronym: Piezo_Ortho, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Universidad Complutense de Madrid, class: OTHER, collaborators name: Osteology Foundation, descriptionModule briefSummary: Research QuestionWhile the reduction in treatment times and the patient satisfaction after periodontally accelerated osteogenic orthodontics (PAOO) are well sustained in the scientific literature, there is still controversy regarding if grafting leads to i) change of the periodontal phenotype and ii) greater stability of post-orthodontic treatment outcomes, highlighting the need of controlled clinical trials.Aims of the ProjectThe aim of this randomized clinical trial (RCT) is to compare piezocision-assisted orthodontics, concomitant to soft tissue grafting (volume-stable collagen matrix), with piezocision-assisted orthodontics, concomitant to bone grafting with a xenograft and a native collagen membrane, in orthodontic non-growing patients. The primary aim will be to determine the impact of this surgical protocol on the hard and soft tissue changes occurring on the buccal aspect of the dentition. Secondary objectives will include the assessment of the comparative impact on treatment duration, rate of tooth movements, presence of root resorption, periodontal parameters, bone level changes and patient-reported outcome measures (PROMs) between the two groups., conditionsModule conditions: Dental Malocclusion, conditions: Maxillary Deficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Comparative 2-arm parallel double-blinded randomized controlled clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Blinded parties will not be aware of the type augmentation used during the intervention., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: flapless alveolar decortication with augmentation, outcomesModule primaryOutcomes measure: Soft tissue contour changes pre- and post- orthodontic therapy, primaryOutcomes measure: Plaque index (PlI), primaryOutcomes measure: Bleeding on probbing (BoP), primaryOutcomes measure: Probing depth (PD), primaryOutcomes measure: External apical root resorption (EARR), primaryOutcomes measure: Orthodontic tooth movement, secondaryOutcomes measure: Percentage of residual pockets (PD>4 mm)., secondaryOutcomes measure: Soft tissue thickness by PIROP ultrasound scanner, secondaryOutcomes measure: Gingival microvasculature, secondaryOutcomes measure: PROMs, secondaryOutcomes measure: Adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Odontology, University Complutense Madrid, status: RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: Eduardo Montero, Prof, role: CONTACT, phone: +34 91 3941901, email: eduardomonterosolis@ucm.es, contacts name: Conchita Martin, Prof, role: CONTACT, phone: +34 91 3941901, email: mariacom@ucm.es, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False