Dental caries. Dental caries
Conditions
Interventions
Intervention 1: Intervention group 1: Subjects will be given IgY-containing gum and after a 10-day rest period, in the second phase, IgY-free gum will be given. Saliva samples will be taken before and
Sponsors
Ministry of Defense and Armed Forces Support - Sepand Organization - Shahsad Motahari Center
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Good oral hygiene (O’Leary plaque index less than or equal to 20%) DMFT minimum 3 and maximum 7 Age range 18 to 35
Exclusion criteria
Exclusion criteria: Use of orthodontic appliances and brackets Use of fixed and removable prostheses Active oral condition (gingivitis, periodontitis, oral thrush, oral herpes, dental abscess) Taking medications that affect saliva (pilocarpine, swimlin, bethanechol, atropine, glycopyrrolate, scopolamine, antihistamines, fluoxetine...) History of head and neck radiotherapy Antibiotics taken three days before and during the study Topical fluoride therapy and use of any antibacterial mouthwash during the study Consumption of probiotic-containing food products during the study Smokers Pregnant and breastfeeding women Participation in another clinical trial study less than 1 month prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colony count of S.mutans bacteria in saliva samples in culture medium in both types of interventions (gum containing and without IgY). Timepoint: 1) Before starting the plan 2) After using gum for 10 days 3) After a period of rest and not using gum for 10 days 4) After prescribing the second dose of gum for 10 days. Method of measurement: Saliva culture and colony formation.;Measuring saliva pH. Timepoint: 1) Before starting the plan 2) After using gum for 10 days 3) After a period of rest and not using gum for 10 days 4) After prescribing the second dose of gum for 10 days. Method of measurement: pH meter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability of the investigational drug product. Timepoint: At the end of the study. Method of measurement: Based on questionnaires related to desirability, intensity and persistence of taste, and chewability in terms of firmness, ease, or feeling of fatigue in the jaw, it will be evaluated.;Assessment of non-sensitivity or reaction to the investigational drug product. Timepoint: Day one (after consuming the first gum), day two, day six, day ten (assessments are made after consuming both types of gum (containing and not containing IgY). Method of measurement: Completing the CRF (Adverse Reactions) form. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamid Aryan Nejad
Ministry of Defense and Armed Forces Support - Sepand Organization - Shahid Motahari Center
Outcome results
None listed