MedDataX Logo

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

NCT ID: NCT06738342

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wound Healing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test group

Group Type EXPERIMENTAL

CHX 0.09% + Citrox + HA

Intervention Type OTHER

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

Control group

Group Type ACTIVE_COMPARATOR

CHX 0.12%

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andrea Pilloni MD DDS MS

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sapienza University of Rome

Rome, Rome, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Andrea Pilloni, Professor

Role: CONTACT

Phone: +39-0649-918152

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Andrea Pilloni

Role: primary

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0460/2022

Identifier Type: -

Identifier Source: org_study_id