Assessment of Topical Application of Chitosan 0.2% Chlorhexidine Gel on Wound Healing in Diabetic Patients

Официальное название

Assessment of Topical Application of Chitosan 0.2% Chlorhexidine Gel on Wound Healing Following Mandibular Trans-alveolar Molar Extraction in Diabetic Patients: A Randomized Controlled Clinical Trial

Обзор

Despite efforts to prevent postoperative discomfort, immediate side effects of surgical extraction of lower molars include bleeding at the site of extraction, inflammation, pain, and alveolar osteitis especially in diabetic patients Bexident Post is a topical gel commercialized by ISDIN labs (ISDIN, Spain) that contains chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol. it has hemostatic, antimicrobial, wound healing properties and proven antiseptic effect.

Подробное описание

The aim of this study is to Evaluate whether the Chitosan + 0.2% CHX gel improves healing after extraction in diabetic patients Material and Methods The main inclusion criteria for this prospective, randomized, double-blinded clinical study will be adults with controlled diabetes (HbA1c \<7) in need of surgical extraction of mandibular molars.

Equal randomization was achieved for 40 patients with the use of a computer-generated random number list, the patient will be divided into two groups , 20 patients for study group and 20 patients for control group. and signed inform consent will be obtained from every patient included in the study .

Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tissue (envelop flap) and , make bone guttering reduction and tooth sectioning and tooth is removed using dental elevators. Study Group: Socket filled with Chitosan + 0.2% CHX gel.

Control Group: No gel, standard instructions only.

Primary outcome measures :

Early Wound Healing Score (EHS).

* Pain: Visual Analogue Scale (VAS). * Swelling : Intraoral swelling score (Edema).

Secondary outcome measures:

• Complications (dry socket, infections )

Вмешательства

• Процедура Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tis
  Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tissue (envelop flap) and , make bone guttering reduction and tooth sectioning and tooth is removed using dental elevators. Study Group: Socket filled with Chitosan + 0.2% CHX gel.

Первичные конечные точки

• Early Wound Healing Score (EHS) [Срок оценки: 3 days,1 week, 2 weeks, 1 month]
• Visual analog scale [Срок оценки: 3 days,1 week, 2 weeks, 1 month.]
• Swelling [Срок оценки: 3 days,1 week, 2 weeks, 1 month]

Критерии участия

Критерии включения

• Adults with controlled diabetes (HbA1c <7
• Mandibular molar extraction indicated

Критерии исключения

• Immunocompromised, allergyto Chitosan/CHX.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Саудовская Аравия · 1 центр

• Tanta University — Al Kharj

Идентификаторы

NCT: NCT07429812 · SCBR-514/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗