NCT06738342
Not yet recruiting
Not Applicable
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
University of Roma La Sapienza1 site in 1 country32 target enrollmentDecember 2024
Overview
- Phase
- Not Applicable
- Intervention
- CHX 0.09% + Citrox + HA
- Conditions
- Wound Healing
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Oedema
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Andrea Pilloni MD DDS MS
Professor
University of Roma La Sapienza
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
Arms & Interventions
Test group
Intervention: CHX 0.09% + Citrox + HA
Control group
Intervention: CHX 0.12%
Outcomes
Primary Outcomes
Oedema
Time Frame: 1, 3, 7 an 14 days
Presence of absence will be recorded (1 or 0).
Secondary Outcomes
- 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 Sites (1)
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