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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06341439
• Other study ID #: Prot. 001_2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 18, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: March 2024
• Source: University of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 mouthwash containing Citrox is used?

• 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 30, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• ASA I and ASA II patients;

• Age > 25 years;

• Non-smokers or smokers < 5 cig/day;

• Presence of periodontal disease;

• >10 natural teeth;

• At least 2 teeth with pockets =5mm;

• Indications for carrying out at least one SRP (scaling and root planing) session;

• Signing of the written informed consent to participate in the study.

Exclusion Criteria:

• Severe general medical pathologies;

• Immunodeficiency states;

• Radiotherapy in the head and neck region;

• Uncontrolled diabetes or hypertension;

• Smokers >5 cigs/day;

• Impossibility to carry out homogeneous and continuous follow-up;

• Documented allergy to chlorhexidine or hyaluronic acid;

• Taking drugs that cause alterations in the gums and oral mucosa;

• Pregnancy or breastfeeding;

• Presence of removable prostheses;

• Periodontal treatment in the previous 6 months.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Device:
• Mouthwash with chlorhexidine 0,12% and CITROX
Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.
• Mouthwash with chlorhexidine 0,12%
Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.

Locations

Country	Name	City	State
Italy	University of L'Aquila, division of periodontology	L'Aquila

Sponsors (1)

Lead Sponsor	Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing Depth (PD)	Effects on post-treatment healing: the Probing Depth was measured in mm	6 months
Primary	Gingival Index (GI)	Effects on post-treatment healing: the GI was assessed with values between 0 and 3 (0- best one, 3 worst one)	6 months
Primary	Plaque Index (PI)	Effects on post-treatment healing: the GI was assessed with values between 0 and 3 (0- best one, 3 worst one)	6 months
Primary	Full mouth plaque score (FMPS)	The FMPS indicate the percentage of sites with plaque out of the total.	6 months
Primary	Full mouth bleeding score (FMBS)	The FMBS indicate the percentage of bleeding sites out of the total.	6 months
Secondary	Patient Reported Outcome Measure (PROMS)	Visual Analogue Scale (SCALE) in the form of a questionnaire to evaluate post-op pain, post-op sensitivity, taste alteration, appearance of staining and pleasantness of the mouthrinse used. The minimum value is 0 while the maximum value is 10. For all questions the best value is 0 and the worst 10, except for pleasantness.	2 weeks post non-surgical periodontal therapy