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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Препарат 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.

Первичные конечные точки

• Oedema [Срок оценки: 1, 3, 7 an 14 days]

Вторичные конечные точки (5)

• Early Healing Score [Срок оценки: 24 hours post surgery, 3, 7 and 45 days post surgery]
• Plaque Index modified by Turesky [Срок оценки: 1,3,7 and 14 days post surgery]
• Gingival Index modified by Trombelli [Срок оценки: 1,3,7 and 14 days post surgery]
• Lobene Index modified [Срок оценки: 1,3,7 and 14 days post surgery]
• Adverse effects [Срок оценки: 1,3,7 and 14 days post surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• Sapienza University of Rome — Rome

Идентификаторы

NCT: NCT06738342 · 0460/2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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