The Effect of Chlorhexidine + Hyaluronic Acid on Postoperative Wound Healing After Lower Third Molar Removal

Официальное название

The Effect of Chlorhexidine (0.5%) With Combination of Hyaluronic Acid on Postoperative Wound Healing After Lower Third Molar Removal: a Placebo Controlled Triple Blind Randomized Clinical Trial

Обзор

Our aim is to evaluate chlorhexidine-hyaluronic acid containing gel on postoperative wound healing regarding impacted lower third molar surgery.

Подробное описание

This is a triple-blind, placebo-controlled randomized clinical trial. Sixty patients will be randomly assigned to two treatment groups: Arm 1 receives Curasept DNA ADS periodontal gel during impacted third molar removal, while Arm 2 receives a placebo gel. Patient allocation uses an electronic randomization system with a 1:1 ratio. Baseline characteristics are recorded at the first clinical visit. The surgical procedure includes local anesthesia, mucoperiosteal flap elevation, bone removal with a surgical handpiece, and wound closure with non-resorbable sutures. Test gel or placebo is applied post-tooth removal, and patients are monitored postoperatively for pain, swelling, and wound healing, including follow-ups on the third, seventh and fourteenth days. Data analysis will use descriptive and statistical methods to evaluate efficacy.

Вмешательства

• Процедура Third molar surgery
  During the operation, after local anaesthetics (LIDOCAIN-ADRENALIN 20 mg/0,01 mg/ml) the same mucoperiosteal (sulcular flap without vertical incision) is raised. Bone removal happens with physio-dispenser driven surgical handpiece (60ml/min irrigation; 8.000-16.000 rpm) and tungsten carbide round drills. Tooth section is made where indicated. After tooth removal wound is rinsed with 10-20ml physiologic salt, the wound is closed with 4.0 monofil non-resorbable suture material and then gel test or

Первичные конечные точки

• Wound healing [Срок оценки: From enrollment to the end of treatment at 2 weeks]

Вторичные конечные точки (4)

• Mouth opening [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Subjective pain level [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Face swelling [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Taken analgesics (questionaire) [Срок оценки: From enrollment to the end of treatment at 2 weeks]

Критерии участия

Критерии включения

• patients having lower impacted third molar
• impaction pattern Pell-Gregory II/A, III/A, I/B, II/B, III/B that means partially impacted, partially erupted teeth, where primary wound closure is usually not possible;

Критерии исключения

• systemic disease (diabetes, steroids, antiresorptive therapy);
• allergy on gel's compounds;
• pregnancy;
• active or subacute local infection at third molar tooth (pericoronitis);
• poor oral hygiene (based on the presence of active caries and/or plaque index of 2-3)

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

Лечение

Центры проведения

Венгрия · 1 центр

• Dept. of Oral and Maxillofacial Surgery, UP — Pécs

Идентификаторы

NCT: NCT07044219 · 7613-PTE 2019.

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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