drugset / Trial / NCT06963788

The Comparative Effects of Using 0.12% Chlorhexidine and Silver Nanoparticles Mouthwashes in Medical Students

NCT06963788

Phase 3 Completed 95 enrolled Can Tho University of Medicine and Pharmacy
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This double-blind, randomized intervention study aims to evaluate and compare the efficacy of 0.12% Chlorhexidine (CHX) mouthwash and Nano Silver (AgNPs) mouthwash. Specifically, it seeks to address the following research questions: How effective are 0.12% CHX and AgNPs mouthwashes in controlling dental plaque accumulation, reducing gingival inflammation, and maintaining salivary pH balance? How do these two mouthwashes compare in terms of relevant clinical parameters? The study design includes three groups: Group I (control), which will receive 0.9% sodium chloride (saline solution); Group II, which will receive 0.12% CHX mouthwash; and Group III, which will receive AgNPs mouthwash. Participants will be selected based on defined inclusion and exclusion criteria. Subjects will be randomly assigned to one of the three groups, ensuring an even distribution of male and female participants. Clinical parameters will be recorded at baseline and after 21 days of intervention. These parameters include the Gingival Index (GI), the Quigley-Hein Plaque Index (QHI), microbial colony counts, and salivary pH levels. Blinding was maintained throughout the study: neither participants nor clinical evaluators were aware of group assignments. The individual responsible for coding the mouthwash formulations was not involved in any other part of the study and disclosed the codes only after data analysis was completed.

Timeline

Start
2024-02-06
Primary completion
2024-04-15
Completion
2024-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Chlorhexidine Small molecule 0.12 % Other
Comparator Silver nanoparticles Unknown Other

Indications

No indication recorded.