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Clinical effects of Lactogum and ParsiLact-LA on oral health

Phase 3
Recruiting
Conditions
Oral health & periodontal status.
Gingivitis and periodontal diseases
Registration Number
IRCT20210821052241N1
Lead Sponsor
Esfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

Patients planned for removable functional orthodontic appliances or full arch both jaws fixed orthodontic appliance therapy.
Good general health.
Good oral health (have a dental history that includes brushing at least once a day).
Be willing and able to comply with the trial regime.
To have normal tooth anatomy, oral mucosa and periodontal status.

Exclusion Criteria

Inability to obtain informed consent.
Presence of allergies, food sensitivities or food intolerance.
Any congenital syndromes of the head and neck.
Medical contraindications such as heart conditions or Gastrointestinal disorders.
Any state or diseases necessitating taking immunosuppressants or antibiotics or any medication chronically prior to the procedures.
Any special physical or mental needs that would compromise patient cooperation.
History of surgery within the past year or planned to have a surgery in the next 90 days.
Severe fever, nausea, vomiting, bloody Diarrhea or severe abdominal pain within the past 1 month.
Chronic use of probiotics or food supplements of any kind and use of antibiotics, steroids, hormones, oral prophylaxis or anti-microbial mouth wash or tooth paste within 1 month before the start of the study.
Use of products containing xylitol and fluoride or other anti cariogenic products.
Poor compliance with oral hygiene regimens; poor periodontal health(presence of calculus and/or periodontal pocket); extensive dental restorations or uncontrolled caries activity.
Pregnancy.
Smoking.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
BOP index. Timepoint: BOP measurement before intervention and 2 months after use of probiotic /placebo. Method of measurement: The number of sites where bleeding is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage.;GI index. Timepoint: GI measurement before intervention and 2 months after use of probiotic/placebo. Method of measurement: Using the gingival index classification.;PI index. Timepoint: PI measurement before intervention and 2 months after use of probiotic/placebo. Method of measurement: Using the plaque index classification.;Saliva pH number. Timepoint: PH saliva measurement before intervention and 2 months after use of probiotic/placebo. Method of measurement: PH meter.
Secondary Outcome Measures
NameTimeMethod
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