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

U

University of Roma La Sapienza

Status

Not yet enrolling

Conditions

Wound Healing

Treatments

Other: CHX 0.09% + Citrox + HA
Drug: CHX 0.12%

Study type

Interventional

Funder types

Other

Identifiers

NCT06738342
0460/2022

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

32 participants in 2 patient groups

Test group
Experimental group
Treatment:
Other: CHX 0.09% + Citrox + HA
Control group
Active Comparator group
Treatment:
Drug: CHX 0.12%

Trial contacts and locations

1

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Central trial contact

Andrea Pilloni, Professor

Data sourced from clinicaltrials.gov

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