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

Not Applicable

Not yet recruiting

• Conditions: Wound Healing
• Interventions: Other: CHX 0.09% + Citrox + HA; Drug: CHX 0.12%

• Registration Number: NCT06738342
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	CHX 0.09% + Citrox + HA	-
Control group	CHX 0.12%	-

Primary Outcome Measures

Name	Time	Method
Oedema	1, 3, 7 an 14 days	Presence of absence will be recorded (1 or 0).

Secondary Outcome Measures

Name	Time	Method
Early Healing Score	24 hours post surgery, 3, 7 and 45 days post surgery	The score comprises three parameters (Clinical signs of re-epithelialization, hemostasis and inflammation) and ranges from 0 (worst healing) to 10 (best healing)
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	1,3,7 and 14 days post surgery	Presence of stains or discolorations of teeth and mucosae
Adverse effects	1,3,7 and 14 days post surgery	Disgeusia, mouth ulcers

Trial Locations

Locations (1)

Sapienza University of Rome; 🇮🇹 Rome, Italy