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.

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

A controlled clinical trial with parallel groups , triple blind, randomized ,phase 2 on 84 patients. The random assignment sequence of individuals was performed using random allocation software.

Study location: Esmetieh health center,under the supervision of Kashmar health network; study population: pregnant women aged 15 to 45 years, between 15 and 28 weeks of gestation, diagnosed with gingivitis; type of blinding: triple-blind; blinding method: mouthwashes will be coded by a third party in identical, unlabeled bottles. The participants, the researcher, and the data analyst will all be blinded to the type of mouthwash.

Inclusion criteria: non-smoking pregnant women aged 15 to 45 years from 15 to 28 weeks of pregnancy; having gingivitis based on validated periodontal indicators; Presence of microbial plaque measured based on scientific indicators; presence of dental pigmentation due to dental infection. Exclusion criteria: lack of willingness to cooperate; having systemic diseases; Use of anti-inflammatory drugs and antibiotics in the past 3 months; severe nausea and vomiting

Intervention group (bistort mouthwash): used twice daily for 14 days; 5ml each time, rinsed for 30 seconds. Control group (chlorhexidine mouthwash): used twice daily for 14 days; 5ml each time, rinsed for 30 seconds.

Oral health-related Quality of life score ; Gingivitis Index; Plaque Index; stain index

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.

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)