NCT06341439

Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX®

Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX® as a Support to Non-surgical Periodontal Therapy: a Randomized Controlled Triple-blind Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of L'Aquila · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The goal of the following clinical trial is to compare the efficacy of a product based on chlorhexidine 0.12% and CITROX and the same product without CITROX in the healing phenomena that occur after non-surgical periodontal therapy. The main questions it aims to answer are: * Is the response to periodontal therapy better if mouthwashes containing bioflavonoids are used as a support to non surgical periodontal therapy? * What is the patients' perception? Participants, divided into 2 groups, are asked to use either one or the other mouthwash for 14 days after non-surgical periodontal therapy.

Detailed description

At baseline, all participants underwent received comprehensive periodontal examination, full-mouth intraoral radiographic analysis and received oral hygiene instruction. All treatments were performed by the same experienced clinician (M.G.L.) After completing NSPT, patients were randomly assigned to the test- or control group through an online random number generator (random.org; www.random.org). Test group participants received a 300 ml bottle of mouthwash containing 0,12% CHX combined with organic acids and bioflavonoids, while the control group received a 300 ml bottle of 0.12% CHX mouthwash. Both bottles were unlabeled to prevent identification by either the patients or the clinician. All participants were instructed to rinse with the undiluted mouthwash twice daily (morning and evening) for 60 seconds over 14 days following subgingival instrumentations. This regimen aligns with the standard use of chlorhexidine mouthwashes. Oral hygiene instructions were provided after both supragingival debridement and subgingival instrumentations with additional training in the use of interdental devices as necessary. Patients were recalled for follow-up assessments at 14 days (T2), 2 months (T3) and 6 months (T4). In these sessions, oral hygiene instructions were reinforced as needed. During the follow-up, no additional periodontal treatments were performed. Patients were subsequently enrolled in a maintenance care program, involving routine professional cleanings every 6 months. Data collected from baseline (T0) to 6 months (T4) were used for the present analysis.

Conditions

• Periodontitis

Interventions

Type	Name	Description
DEVICE	Mouthwash with chlorhexidine 0,12% and CITROX	Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.
DEVICE	Mouthwash with chlorhexidine 0,12%	Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-06-01
• Completion: 2025-02-28
• First posted: 2024-04-02
• Last updated: 2025-03-21

Locations

1 site across 1 country: Italy