Probiotics for gum health during treatment with braces

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: Subjects will be randomized into 2 groups with the aid of a computer program: Intervention group: Probiotic tablet + Usual home oral hygiene [according to manufacturer instructions, the participants will chew two tablets once daily for 3 months] No Intervention group: Usual home oral hygiene Data recordings of all patients will take place at baseline and 3 months [end of study] by previously calibrated examiner blinded for the group assignment, assessing plaque, gingivitis, gingival bleeding, potential adverse effects and patient‐reported outcomes. Moreover, at baseline and 3‐month examinations [end of study], whole saliva samples will be collected for salivary microbiome determination. CONDITION: Gingivitis, malocclusion treatment ; Oral Health PRIMARY OUTCOME: Gingival bleeding on probing: percentage of the buccal mesial, midline and distal sites from second premolar to second premolar which bleed upon probing, using the criteria for bleeding of the Gingival Index (Löe and Silness, 1963) at baseline and 3 months SECONDARY OUTCOME: ; Measured at baseline and 3 months:; 1. Gingival Index assessed on the buccal surfaces from second premolar to second premolar (Löe and Silness, 1963); 2. Plaque Index modified (Clerehugh et al., 1998); 3. Potential adverse effects: inspection of the hard and soft oral cavity tissues and self‐reported; 4. Patient‐reported outcomes (adapted from Herrera et al., 2017); INCLUSION CRITERIA: 1. Healthy individuals, aged under 18 years, planned for simultaneous full arch upper and lower fixed labial orthodontic appliance therapy from second premolar to second premolar 2. In good general health 3. Have a dental history that includes brushing at least once a day 4. Willing and able to comply with the trial regime 5. Normal anatomical periodontal attachment 6. Gingival bleeding on probing on at least 30% of the buccal mesial, midline and distal sites of the teeth examined using the criteria for bleeding of the Gingival Index (Löe and Silness, 1963).
Epistemonikos ID: 3e364c01009a3c07d445c7a77759826b3be85116
First added on: Aug 24, 2024