Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CHX 0.09% + Citrox + HA, CHX 0.12%.
- Who it may be relevant to
- Registry conditions: Wound Healing. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Other 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. - Drug 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.
Primary outcome measures
- Oedema [Time frame: 1, 3, 7 an 14 days]
Secondary outcome measures (5)
- Early Healing Score [Time frame: 24 hours post surgery, 3, 7 and 45 days post surgery]
- Plaque Index modified by Turesky [Time frame: 1,3,7 and 14 days post surgery]
- Gingival Index modified by Trombelli [Time frame: 1,3,7 and 14 days post surgery]
- Lobene Index modified [Time frame: 1,3,7 and 14 days post surgery]
- Adverse effects [Time frame: 1,3,7 and 14 days post surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- Sapienza University of Rome — Rome
Identifiers
NCT: NCT06738342 · 0460/2022