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IRCT20241221064118N1 IRCT 2025-06-14 Mashhad University of Medical Sciences Effect of bistort mouthwash on pregnancy gingivitis Comparison of the effect of bistort mouthwash with chlorhexidine mouthwash on periodontal indices and oral health-related quality of life in pregnant women with gingivitis. 2025-08-23 anticipated 84 Complete https://irct.ir/trial/80904 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 1. The random allocation sequence was generated using random allocation software, with permuted blocks of size four. A total of 21 blocks were created to allocate 84 participants. 2. The randomization sequence was enclosed in sealed opaque envelopes to prevent disclosure of allocation order. 3. After enrollment and obtaining written informed consent, a sealed envelope was opened in numerical order to determine the assigned intervention. this process was conducted by an individual independent of the research team, Blinding description: Random allocation of participants was performed using random allocation software،which fully ensures allocation concealment.mouthwashes were packaged in identical dark containers.participants ،assessors،investigators،and statisticians were blinded to group allocation(triple-blind study). 2 Pregnancy Gingivitis. Intervention 1: Intervention group: Participants in this group will use bistort mouthwash twice daily for 2 weeks after scaling and receiving routine oral hygiene education. Patients should refrain from eating and drinking for one hour after using the mouthwash. Intervention 2: Control group: participants in this group will use 0.2% chlorhexidine mouthwash twice daily for 2 weeks after scaling and receiving routine oral hygiene education. Patients should refrain from eating and drinking for one hour after using the mouthwash. 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 At present, no definitive decision has been made regarding the sharing of anonymized individual participant data.After the completion of the study and data analysis ,a decision will be made about how and whether to share these data.
public Fahimeh ebrahimi
No.79,Amir Kabir Street, Kashmar,Iran
Kashmar Iran (Islamic Republic of) 9671986150 +98 51 5523 0425 ebrahimisfpp@gmail.com Mashhad University of Medical Sciences scientific Fahimeh Ebrahimi
No.79,Amir Kabir street,Kashmar,Iran
Kashmar Iran (Islamic Republic of) 9671986150 +98 51 5523 0425 ebrahimisfpp@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Pregnant women from 15 to 28 weeks of pregnancy Aged 15 to 45 years Non-smoker Having gingivitis based on validated periodontal indicators Presence of microbial plaque measured based on scientific indicators If the presence of tooth discoloration is due to a dental infection No need for antibiotic prophylaxis 15 years 45 years Female Use of anti-inflammatory drugs and antibiotics in the past 3 months Nausea and vomiting during pregnancy Having systemic disease Reluctance to cooperate K05 Gingivitis and periodontal diseases Prevention Prevention Intervention group: Participants in this group will use bistort mouthwash twice daily for 2 weeks after scaling and receiving routine oral hygiene education. Patients should refrain from eating and drinking for one hour after using the mouthwash. Control group: participants in this group will use 0.2% chlorhexidine mouthwash twice daily for 2 weeks after scaling and receiving routine oral hygiene education. Patients should refrain from eating and drinking for one hour after using the mouthwash. Plaque Index. Timepoint: At baseline and two weeks after the intervention. Method of measurement: Clinically assessed by a trained evaluator using the silness & loe plaque index. Gingival index. Timepoint: At baseline and two weeks after the intervention. Method of measurement: clinically assessed by a trained evaluator using the loe & silness Gingival index. Stain Index. Timepoint: At baseline and two weeks after the intervention. Method of measurement: Clinically examined and scored using standard visual methods by trained evaluator. Oral Health -Related Quality of Life. Timepoint: At baseline and two weeks after the intervention. Method of measurement: Self-reported by participants using the standardized OHIP-14 questionnaire. Mashhad University of Medical Sciences Approved 2025-06-01 Ethics committee of Mashhad University of Medical Sciences Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)