Comparison of the effects of a combined mouthwash of tranexamic acid and cetylpyridinium chloride in plaque reduction and bleeding control in patients undergoing crown lengthening surgery: A randomized, triple-blind clinical trial

Comparison of the efficacy of a combined mouthwash (TXA 5% + CPC 0.05%) versus 0.2% chlorhexidine mouthwash in controlling bleeding and reducing plaque following crown lengthening surgery

Randomized, block, triple-blind, parallel, single-center, clinical trial

In the Department of Periodontology, Mashhad School of Dentistry, participants will be randomly assigned to two groups: intervention and control. Care providers, outcome assessors, and the data analyst are blinded.

Inclusion 18–70, ASA I–II, periodontal, no-antibiotic, no-antiseptic, no-anticoagulant, normal-coagulation, oral-hygiene, consent, follow-up Exclusion ASA ≥III, systemic-disease, coagulopathy, anticoagulant, pregnancy, lactation, allergy, oral-infection, poor-hygiene, interfering-drugs, incapacity

Patients who use a combined mouthwash of tranexamic acid (5%) and cetylpyridinium chloride (0.05%) following crown lengthening surgery.

Presence or absence of bleeding, OLeary plaque index

Randomization method: Block randomization Software used: Random Allocation Software Type of randomization: Block Allocation concealment method: Sealed opaque envelopes An independent colleague not involved in study assessments prepares the block randomization allocation list using Random Allocation Software with alternating block sizes of 4 and 6. Allocation concealment: Group codes (A and B) are placed in opaque, sequentially numbered, sealed envelopes. These envelopes are opened by someone other than the assessor after the patient's enrollment is finalized and just before the intervention begins.

This study was designed as a triple-blind randomized clinical trial. Participants, the surgeon, the outcome assessor, and the statistical analyst were all blinded to group allocation. To implement blinding, the mouthwashes were packaged by an individual outside the research team who was not involved in treatment, outcome assessment, or data analysis. The mouthwashes were placed in identical bottles in terms of shape, color, volume, and labeling. Each bottle was identified only by a unique code, and the code list was kept with the individual responsible for randomization and was not disclosed until after the statistical analysis was completed. Participants received mouthwashes based on the assigned codes and were unaware of the type of solution they used. The surgeon and the clinical assessor recording outcome measures also had no access to group allocation. Data recording forms contained only participant codes. Data collection was performed by a trained assessor who was blinded to treatment allocation. Statistical analysis was conducted using coded data by an analyst who had no knowledge of group identities..

اطلاعات بیشتری وجود ندارد

Study protocol and final clinical study report The approved study protocol registered in IRCT and the final clinical study report published in a peer reviewed journal will be available. No individual participant data will be shared.

The study protocol will be available upon registration in IRCT. The final clinical study report will be available after publication of the study results, with no time limitation.

The study protocol and published report will be publicly accessible to researchers, clinicians, and academic institutions.

Documents may be used for academic and research purposes with appropriate citation. Commercial use requires formal permission from the principal investigator and affiliated institution.

The protocol is accessible via the IRCT registry website. The final report will be available through the published journal article. For further information, contact the principal investigator via institutional email.

No formal application is required for accessing the protocol or published report. For commercial inquiries, written permission must be obtained from the principal investigator and institution.