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IRCT20260413069067N1 IRCT 2026-04-16 Zist‑Takhmir Pharmaceutical Company Evaluation of the efficacy of probiotic on oral malodor Evaluation of the efficacy of probiotic lozenges containing Streptococcus salivarius on oral malodor and quality of life of patients with halitosis 2026-04-21 anticipated 60 Complete https://irct.ir/trial/89454 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: The randomization method will be block randomization, assigning participants to two treatment groups (control and intervention), which will be performed using software.Participants will be randomly assigned to either the intervention or control group using a block randomization method to ensure balanced allocation throughout the study. A computer‑generated randomization sequence will be produced using Microsoft Excel’s RANDBETWEEN function (or equivalent random number generator). Fixed block sizes of 4 and 6 will be used in a random order to prevent prediction of group assignments and to ensure equal distribution within each block. The randomization list will be generated by an independent researcher who is not involved in participant recruitment, clinical examination, or outcome assessment. Each allocation code will be placed in opaque, sequentially numbered, sealed envelopes to maintain allocation concealment. During participant enrollment, the next envelope in sequence will be opened by a study coordinator who is blinded to the study hypotheses. The participant will then be assigned to the intervention (probiotic) or control (placebo) group according to the concealed sequence, Blinding description: Participants are invited to join, provide informed consent, and are then randomized into intervention and control groups. They are not informed whether they are receiving the Lactobacillus salivarius probiotic or a placebo, nor are they told which group they are assigned to. The assessor, who confirms the patient's halitosis, is unaware of which patient receives which medication, as they will re-evaluate patients after treatment. The clinical monitor distributes the medications using a randomized list of patient names. This monitor has no knowledge of which patient received which drug and has no contact with the assessor. The data analyst is also not informed about which patient receives which medication, assuming all participants received the intervention, even though some may have received a placebo. The Data Safety Monitoring Board ensures that study participants and all personnel interacting with them remain unaware of the study group assignments. 3 oral malodor (Halitosis). Intervention 1: Intervention group: Intervention ProcedureIn the intervention group, participants receive a 5–10 minute, face‑to‑face oral hygiene instruction session delivered by a senior (final‑year) dental student who is not involved in the organoleptic assessment process. The educational session covers essential principles of oral hygiene, including the correct tooth‑brushing technique, proper use of dental floss, and tongue cleaning using a tongue scraper. The tongue scraper provided is a U‑shaped plastic device.Following oral hygiene instruction, patients are educated on the proper use of the probiotic lozenge according to the manufacturer’s guidelines. They are instructed to chew one probiotic lozenge completely every night before bedtime, after brushing their teeth, and to avoid eating or drinking anything until the next morning.The probiotic lozenge (Lactogum), manufactured by Zist‑Takhmir Company, contains more than 10910 9 CFU of Streptococcus salivarius strains, including 150 mg of strain K12 and 150 mg of strain M18.Participants in the intervention group are re‑evaluated at weeks 4 and 8. Each follow‑up visit includes: assessment of any potential adverse effects, verification of the consumption of prohibited medications, and monitoring of oral malodor using standardized oral‑hygiene–related indices. These assessments consist of the Tongue Coating Index, the organoleptic test, the HALT quality‑of‑life questionnaire, and the Bad Breath Improvement self‑assessment test (BBI) following the intervention.Additionally, participants receive a follow‑up chart (Appendix 3) to record their daily oral hygiene practices, including the number of tooth‑brushing episodes, flossing frequency, and lozenge consumption. This chart is collected at the 4‑week and 8‑week follow‑up visits for data recording. Intervention 2: Control group: Control Group ProcedureParticipants in the control group receive a 5–10 minute oral hygiene instruction session covering the essential principles of oral hygiene, including proper tooth‑brushing technique, correct use of dental floss, and tongue cleaning with a tongue scraper (a U‑shaped plastic device).In this group, instead of the probiotic lozenge, participants are given a placebo lozenge that is identical in appearance, taste, and texture but contains no Streptococcus salivarius strains.Participants in the control group are re‑evaluated at weeks 4 and 8. Each follow‑up visit includes: assessment of any potential adverse effects, verification of the consumption of prohibited medications, and monitoring of oral malodor using standardized oral‑hygiene–related indices. These assessments consist of the Tongue Coating Index, the organoleptic test, the HALT quality‑of‑life questionnaire, and the Bad Breath Improvement self‑assessment test (BBI) following the intervention.Additionally, participants receive a follow‑up chart (Appendix 3) to record their daily oral hygiene practices, including the number of tooth‑brushing episodes, flossing frequency, and lozenge consumption. This chart is collected at the 4‑week and 8‑week follow‑up visits for data recording. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No additional information is available.
public Nastaran Najd
Karaj – 45‑Meter Golshahr Avenue – Ketouyi‑zadeh Square – School of Dentistry
karaj Iran (Islamic Republic of) 3198684868 +98 26 3350 0080 nastarannajd1993@gmail.com Karaj University of Medical Sciences scientific Nastaran Najd
No12,Katoizade street.,Alborz Univercity Medical sience
Alborz Iran (Islamic Republic of) 3198684868 +98 26 3464 3705 nastarannajd1993@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) individuals with halitosis confirmed by an examiner using organoleptic testing absence of systemic diseases affecting breath odor (diabetes, liver failure, gastrointestinal issues, etc. no use of antibiotics or antibacterial mouthwashes in the last two weeks no consumption of cigarettes or alcohol, not being pregnant or breastfeeding, and the ability to adhere to the study protocol (consuming probiotic pills) 18 years 60 years Both Individuals who have halitophobia and halitosis of non-oral origin. Individuals who are taking antibiotics due to other infectious diseases. Individuals due to consumption of cigarettes and other tobacco products, and alcohol. Treatment - Drugs Placebo Intervention group: Intervention ProcedureIn the intervention group, participants receive a 5–10 minute, face‑to‑face oral hygiene instruction session delivered by a senior (final‑year) dental student who is not involved in the organoleptic assessment process. The educational session covers essential principles of oral hygiene, including the correct tooth‑brushing technique, proper use of dental floss, and tongue cleaning using a tongue scraper. The tongue scraper provided is a U‑shaped plastic device.Following oral hygiene instruction, patients are educated on the proper use of the probiotic lozenge according to the manufacturer’s guidelines. They are instructed to chew one probiotic lozenge completely every night before bedtime, after brushing their teeth, and to avoid eating or drinking anything until the next morning.The probiotic lozenge (Lactogum), manufactured by Zist‑Takhmir Company, contains more than 10910 9 CFU of Streptococcus salivarius strains, including 150 mg of strain K12 and 150 mg of strain M18.Participants in the intervention group are re‑evaluated at weeks 4 and 8. Each follow‑up visit includes: assessment of any potential adverse effects, verification of the consumption of prohibited medications, and monitoring of oral malodor using standardized oral‑hygiene–related indices. These assessments consist of the Tongue Coating Index, the organoleptic test, the HALT quality‑of‑life questionnaire, and the Bad Breath Improvement self‑assessment test (BBI) following the intervention.Additionally, participants receive a follow‑up chart (Appendix 3) to record their daily oral hygiene practices, including the number of tooth‑brushing episodes, flossing frequency, and lozenge consumption. This chart is collected at the 4‑week and 8‑week follow‑up visits for data recording. Control group: Control Group ProcedureParticipants in the control group receive a 5–10 minute oral hygiene instruction session covering the essential principles of oral hygiene, including proper tooth‑brushing technique, correct use of dental floss, and tongue cleaning with a tongue scraper (a U‑shaped plastic device).In this group, instead of the probiotic lozenge, participants are given a placebo lozenge that is identical in appearance, taste, and texture but contains no Streptococcus salivarius strains.Participants in the control group are re‑evaluated at weeks 4 and 8. Each follow‑up visit includes: assessment of any potential adverse effects, verification of the consumption of prohibited medications, and monitoring of oral malodor using standardized oral‑hygiene–related indices. These assessments consist of the Tongue Coating Index, the organoleptic test, the HALT quality‑of‑life questionnaire, and the Bad Breath Improvement self‑assessment test (BBI) following the intervention.Additionally, participants receive a follow‑up chart (Appendix 3) to record their daily oral hygiene practices, including the number of tooth‑brushing episodes, flossing frequency, and lozenge consumption. This chart is collected at the 4‑week and 8‑week follow‑up visits for data recording. Halitosis severity (oral malodor). Timepoint: At baseline, and at weeks 4 and 8. Method of measurement: Assessed through the Halitosis Consultation Hour self‑report questionnaire and based on the organoleptic test (evaluation of oral malodor intensity by the examiner’s sense of smell, using the nose without any instrument).Scores are interpreted as follows:• 0–1: Normal, no halitosis• >2: Indicates genuine halitosis• >3: Moderate to severe halitosis. Halitosis Associated Life-Quality Test. Timepoint: At baseline, and at weeks 4 and 8. Method of measurement: It is a standardized and specialized questionnaire designed to assess the impact of halitosis (oral malodor) on individuals’ quality of life.A total score of:• Less than 30: Very little or no impact• 30–45: Mild to moderate impact• 46–60: Moderate to severe impact. Self‑assessment test for improvement of oral malodor. Timepoint: At baseline, and at weeks 4 and 8. Method of measurement: Assessment of the individual’s perception of changes in the severity of oral malodor, based on self‑report.Scores are interpreted as follows:• 1: Significantly improved• 2: Improved• 3: No change• 4: Worsened• 5: Significantly worsened. Tongue Coating Index. Timepoint: At baseline, and at weeks 4 and 8. Method of measurement: title: Tongue Coating Index for Assessing Dorsal Tongue Plaque CoverageDefinition and scoring:Area assessed: Dorsal surface of the tongueZonal mapping: The tongue dorsum is divided into 6 regionsScoring per region: Each region is scored based on plaque coverageTotal score: Sum of the 6 regional scoresInterpretation of total score:0–4: Oral halitosis unlikely5–9: Commonly observed in oral halitosis10–14: Strong association with oral halitosis15–18: Almost invariably present with oral halitosis. Organoleptic Test. Timepoint: At baseline, and at weeks 4 and 8. Method of measurement: Organoleptic Assessment of Oral Malodor IntensityThe intensity of oral malodor is evaluated by the examiner’s sense of smell, using the nose directly without any instrumental aid.Scoring criteria:Score 0–1: Normal, no halitosisScore ≥2: Indicates genuine halitosisScore ≥3: Represents moderate to severe halitosis. Zist‑Takhmir Pharmaceutical Company Approved 2026-02-25 Ethics Committee of Alborz University of Medical Sciences Karaj – 45‑Meter Golshahr – Safarian Alley – Deputy of Research and Technology Alborz(Karaj) Alborz Iran (Islamic Republic of)