Gingivitis, malocclusion treatment Oral Health
Conditions
Interventions
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, th
Sponsors
Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
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).
Exclusion criteria
Exclusion criteria: 1. Inability to make informed consent 2. Allergies, sensitivities or food intolerance 3. Presence of any congenital syndromes of the head and neck 4. Medical contraindications such as heart condition, immucompromised state or diseases necessitating antibiotic cover prior to procedures, use of immunosuppressants, 5. History of surgery within the past year or planned within the next 90 days 6. Severe nausea, fever, vomiting, bloody diarrhea or severe abdominal pain within the past one month 7. Presence of special physical or mental needs that would compromise manual dexterity 8. Chronic use of medications of any kind, probiotics or food supplements of any kind 9. Use of antibiotics, anti-inflammatory, steroids or hormones within one month from the start of the study. 10. Oral prophylaxis within one month from the start of the study. 11. Use of antibacterial mouthrinses or toothpastes with supplementary antibacterial agents. 12. Poor compliance with oral hygiene regimens 13. Poor periodontal health such as presence of supragingival calculus, subgingival calculus or periodontal pocketing 14. Extensive dental restorations or uncontrolled caries activity 15. Pregnancy, smokers 16. Planned use of premolar bands
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Arab Emirates
Outcome results
None listed