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Clinical effects of Lactogum and ParsiLact-LA on oral health

Evaluation of clinical effects of two probiotic products, Lactogum & ParsiLact-LA on oral health of patients treated with removable and fixed orthodontic appliances

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210821052241N1
Enrollment
60
Registered
2021-10-20
Start date
2021-10-07
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral health & periodontal status. Gingivitis and periodontal diseases

Interventions

Intervention 1: Intervention group 1: Prior to the intervention, their PI, GI, BOP and saliva PH indices will be evaluated. Then they will take a lozenge from Zist Takhmir company (Lactogum), which co

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeid Sadeghian

Esfahan University of Medical Sciences

sadeghian@dnt.mui.ac.ir+98 31 3792 5543

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026