Periodontal disease/periodontitis stage II Oral Health
Conditions
Interventions
Participants will be randomly assigned to one of the following groups: (i) treatment or (ii) control-placebo group:
Single session for the administration of (i) BoNTA or (ii) saline solution (0.9% NaC
Sponsors
Universidade do Porto
Egas Moniz Center for Interdisciplinary Research (CiiEM)
Egas Moniz School of Health & Science
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Systemically healthy 2. females 3. = 18 years old and < 65 years of age 4. Psychologically healthy individuals 5. with desire to improve facial aesthetics 6. Naïve to BoNTA. 7. Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained. 8. Clinical evidence of periodontitis (STAGE-II): Radiograph bone loss (coronal third – 15-33%), at least with one interdental area of periodontal pocket depth (PPD) = 5 mm, bleeding on probing (BOP), and attachment loss (CAL) 3-4 mm, in any area of their mouth (excluding third molars and distal of second molars). 9. Clinical evidence of upper face hyperdynamic lines, GLOGAU scale I-IV. 10. Full mouth (marginal) bleeding and plaque scores (FMBS and FMPS) – no restrictions. 11. No non-surgical periodontal treatment or facial aesthetic interventions completed within 6 months prior to assessment for eligibility.
Exclusion criteria
Exclusion criteria: 1. Medical history that includes diabetes type 1 or hepatic or renal disease, or other serious medical conditions (e.g., Compromise respiratory function, neuromuscular disorders) or transmittable diseases (e.g. cardiovascular disease or AIDS). 2. Antibiotic or anti-inflammatory therapy during the month preceding the baseline exam. 3. Calcium channel blockers, anticholinergic, cyclosporine, aminoglycosides, or any drug that can interfere with neuromuscular transmission. 4. Chronic treatment (>2 weeks) with anticoagulants, corticosteroids or other medications that can severely impact on bone formation. 5. History of alcohol or drug abuse. 6. Smoking =10 cigarettes a day. 7. Self-reported pregnancy or lactation. 8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial. 9. Patients with known hypersensitivity to Botulinum Toxin or any constituents of the commercially available formulations, including reconstitution diluent. 10. Presence of active infection at the injection-site. 11. Clinical evidence of STAGE-I, III, IV periodontitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding on probing (BOP) and periodontal pocket depth (PPD) measurements, at baseline and 4 weeks post-treatment, which will allow to evaluate the difference among groups for the percentage of volunteers achieving a stable treatment response (whole mouth BOP10%, PPD =4mm and no BOP), or unstable response (PPD = 5mm, or = 4mm and presence of BOP). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Post-operative change in global levels of inflammation, neurogenic inflammation and periodontal inflammation, through inflammatory mediators’ biomarkers, 2 weeks after baseline and 4 weeks following intervention: 1.1. Collected from saliva – cytokines IL-6, IL-1ß, TNF-a 1.2. Collected from gingival crevicular fluid (GCF) - IL-6, IL-1ß, TNF-a 1.3. Collected from blood/systemic - C-reactive protein (CRP) and calcitonin gene-related peptide (CGRP). 2. Psychological-stress levels measured at baseline or 2 weeks after baseline and 4 weeks following intervention: 2.1. Collected from saliva - cortisol and dehydroepiandrosterone (DHEA) levels (2weeks after baseline and 4 weeks after intervention) 2.2. Portuguese validated version of Perceived Self Stress Scale (PSS) (baseline and 4 weeks after intervention) 2.3. Portuguese version validated FACE-Q scales (baseline and 4 weeks after intervention) 3. Periodontal tissues clinical parameters measured by calibrated examiners at baseline and 4 weeks following intervention: 3.1. full mouth bleeding score (FMBS) - The % FMBS score will be measured by the number of surfaces positive for BS X 100 divided by the total number of teeth X 4. 3.2. full mouth plaque score (FMPS) – The % FMPS score will be measured by the number of surfaces positive for PS X 100 divided by the total number of teeth X 4. 3.3. clinical attachment level (CAL) - measured with probe in millimeters (probing pocket-depth (PPD) plus distance from top gingival margin to Cemento Enamel Junction (CEJ) [+, - or =]) 3.4. radiographic parameters. 4. Skin objective analysis: change in wrinkles, furrows, folds, and creases assessed with 2D/3D imaging skin analysis, measured at baseline and 4 weeks following intervention. 5. Changes in patient reported outcome measurements (PROMs) measured at baseline and 4 weeks following intervention with Portuguese validated versions of: 5.1. Perceived Self Stress Scale (PSS)-10 5.2. Oral Health Impact Profile 14 (OHIP-14-P | — |
Countries
Portugal
Contacts
Public ContactInes Novo Pereira
Outcome results
None listed