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

NCT06738342 | Not Yet Recruiting

• 1 other identifier: 0460/2022
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (1)

• Oedema

  Presence of absence will be recorded (1 or 0).

  1, 3, 7 an 14 days

Secondary Outcomes (5)

• Early Healing Score

  24 hours post surgery, 3, 7 and 45 days post surgery

• 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

• Adverse effects

  1,3,7 and 14 days post surgery

Study Arms (2)

Test group

EXPERIMENTAL

Other: CHX 0.09% + Citrox + HA

Control group

ACTIVE COMPARATOR

Drug: CHX 0.12%

Interventions

CHX 0.09% + Citrox + HA OTHER

The patient will use the assigned mouthwash starting 24 hours after the surgical procedures and continuing twice a day for 14 days.

Test group

CHX 0.12% DRUG

The patient will use the assigned mouthwash starting 24 hours after the surgical procedures and continuing twice a day for 14 days.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Rome, Rome, 00161, Italy

Location

Central Study Contacts

Andrea Pilloni, Professor

CONTACT

+39-0649-918152; andrea.pilloni@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

IT (1)