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NCT Number: NCT06738342

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Oedema

    Time frame: 1, 3, 7 an 14 days

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

Secondary outcomes

  1. Early Healing Score

    Time frame: 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)

  2. Plaque Index modified by Turesky

    Time frame: 1,3,7 and 14 days post surgery

  3. Gingival Index modified by Trombelli

    Time frame: 1,3,7 and 14 days post surgery

  4. Lobene Index modified

    Time frame: 1,3,7 and 14 days post surgery

    Presence of stains or discolorations of teeth and mucosae

  5. Adverse effects

    Time frame: 1,3,7 and 14 days post surgery

    Disgeusia, mouth ulcers

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Pilloni, Professor

CONTACT

[email protected]

+39-0649-918152

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Acronym: CUR_01

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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