Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara (CUR_01)

Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara in Patients Undergoing Periodontal Surgery: a Triple-blind, Parallel-arm, Randomized Controlled Trial

The primary objective of the study is the evaluation of efficacy of a mouthwash cointaining Chlorexidine (CHX) 0.09% + HA + Citrox (test group) on the quality of wound healing and the presence plaque formation and gingival inflammation in the post-surgical phase. Futhermore stains, discolorations and adverse effects will be eventually recorded. Control group will be represented by the use of a CHX 0.12% mouthwash.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Healing
• Intervention / Treatment: Other: CHX 0.09% + Citrox + HA; Drug: CHX 0.12%

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Pilloni, Professor; Phone Number: +39-0649-918152; Email: andrea.pilloni@uniroma1.it

Study Locations

• Italy
  • Rome, Italy, 00161
    • Sapienza University of Rome
    • Contact: Andrea Pilloni; Email: andrea.pilloni@uniroma1.it
    • Contact: Phone Number: +39-0649-918152

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• More than 20 natural teeth excluding the third molars
• Clinical indication for a surgical intervention for the treatment of at least one residual pocket after non-surgical therapy (pocket depth (PD) ≥5mm)
• Have a full mouth plaque score (FMPS) <15% before surgery;
• Have a full mouth bleeding score (FMBS) <15% before surgery;
• Ability and willingness to give written informed consent;
• Written agreement to participate in the trial.

Exclusion Criteria:

• Use of medications, such as anti-platelet or anti-coagulant agents, any other concomitant systemic disorder, cardiovascular and diabetes diseases, allergic, infectious diseases and medications affecting periodontal inflammation
• Pregnancy or breastfeeding;
• Use of medication affecting the healing process;
• Assumption of systemic or local antibiotics in the 4 weeks before trial beginning;
• Conditions of the teeth or of the site that contraindicate the surgery (severe mobility, fractures, untreated endodontic lesions, incongruous restorations);
• Patients with previous periodontal treatment or who were undergoing a course of dental or orthodontic treatment will be also excluded.
• Tobacco use (10 or more cigarettes per day)
• Inability to comply with protocol
• Uncooperative patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Drug: CHX 0.12%; The patient will use the assigned mouthwash starting 24 hours after the surgical procedures and continuing twice a day for 14 days.
Experimental: Test group	Other: CHX 0.09% + Citrox + HA; The patient will use the assigned mouthwash starting 24 hours after the surgical procedures and continuing twice a day for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oedema	Presence of absence will be recorded (1 or 0).	1, 3, 7 an 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index modified by Turesky		1,3,7 and 14 days post surgery
Gingival Index modified by Trombelli		1,3,7 and 14 days post surgery
Lobene Index modified	Presence of stains or discolorations of teeth and mucosae	1,3,7 and 14 days post surgery
Adverse effects	Disgeusia, mouth ulcers	1,3,7 and 14 days post surgery
Early Healing Score	The score comprises three parameters (Clinical signs of re-epithelialization, hemostasis and inflammation) and ranges from 0 (worst healing) to 10 (best healing)	24 hours post surgery, 3, 7 and 45 days post surgery

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 0460/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No