Clinical trial NCT06341439: Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX®
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Periodontitis
Non-surgical therapy
Chlorhexidine
Mouthwash
Plaque
Randomized trial
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Full mouth bleeding score (FMBS)
timeFrame: baseline, 14 days, 2 months, 6 months
measure: Full mouth plaque score (FMPS)
timeFrame: baseline, 14 days, 2 months, 6 months
measure: Probing Depth (PD)
timeFrame: baseline, 2 months, 6 months
measure: Gingival Index (GI)
timeFrame: baseline, 14 days, 2 months, 6 months
measure: Plaque Index (PI)
timeFrame: baseline, 14 days, 2 months, 6 months
Secondary outcomes:
measure: Patient Reported Outcome Measure (PROMS)
timeFrame: 2 weeks post non-surgical periodontal therapy
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: University of L'Aquila, division of periodontology
Study officials:
affiliation: University of L'Aquila
name: Enrico Marchetti, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: