Skip to main content
OpenTrials
Completed

NCT Number: NCT06341439

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of L'Aquila, division of periodontology

L’Aquila, 67100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I and ASA II patients;
  • Age > 21 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.

Treatment and study plan

Mouthwash with chlorhexidine 0,12% and CITROX

Device

Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.

Mouthwash with chlorhexidine 0,12%

Device

Patients use the undiluted mouthwash 2 times a day for 14 days after performing normal brushing.

Primary outcomes

  1. Full mouth bleeding score (FMBS)

    Time frame: baseline, 14 days, 2 months, 6 months

    The FMBS indicate the percentage of bleeding sites out of the total.

  2. Full mouth plaque score (FMPS)

    Time frame: baseline, 14 days, 2 months, 6 months

    The FMPS indicate the percentage of sites with plaque out of the total.

  3. Probing Depth (PD)

    Time frame: baseline, 2 months, 6 months

    Effects on post-treatment healing: the Probing Depth was measured in mm

  4. Gingival Index (GI)

    Time frame: baseline, 14 days, 2 months, 6 months

    Effects on post-treatment healing: the GI was assessed with values between 0 and 3 (0- best one, 3 worst one)

  5. Plaque Index (PI)

    Time frame: baseline, 14 days, 2 months, 6 months

    Effects on post-treatment healing: the GI was assessed with values between 0 and 3 (0- best one, 3 worst one)

Secondary outcomes

  1. Patient Reported Outcome Measure (PROMS)

    Time frame: 2 weeks post non-surgical periodontal therapy

    Visual Analogue Scale (VAS) 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.

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 2, 2024
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.