Effect of NBF Gingival Gel Application in Controlling Post-surgical Complications After Impacted Lower Third Molar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Alveolar Osteitis: intense neuralgic pain in the post-extraction socket in the second or third postoperative day that do not disappear with analgesics beside a partially or totally disintegrated clot
研究概览
简要总结
Background: Alveolar osteitis is one of the most frequent complications after lower third molar extraction, and is usually accompanied by inflammation, pain and poor wound healing. Several local interventions have been used to reduce these complications with limited effectiveness.
Purpose: To clinically evaluate the use of propolis extract, nanovitamin C and nanovitamin E gel for the prevention of surgical complications related to impacted lower third molar extraction.
Methods: A randomized, triple-blind, split-mouth, pilot study is being performed in patients needing bilateral lower third molar extraction with similar surgical difficulty. Surgical extractions are randomly being performed and NBF gingival gel (TG) or placebo (PBG) are randomly being applied inside postextraction sockets by a blinded surgeon. The patients are being instructed to apply it 3 times/day in the surgical wound for 7 days. One month later, the contralateral wisdom tooth is being extracted and the opposite gel is being applied. Alveolar osteitis (AO) is being diagnosed following Blum's criteria. Swelling is being assessed by measuring the facial perimeter. Wound healing is being evaluated with a semi-quantitative scale as good, satisfactory or insufficient. Postoperative pain is being recorded using a visual analog scale (VAS) for 7 days. Analgesic pill intake is being recorded by each patient. Variables are being registered by a blinded researcher to 3M extractions at one, two, three and seven postoperative days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria are:
- •cooperative adult patients able to fulfil the study protocol,
- •needing surgical extractions of both lower third molars,
- •with similar surgical difficulty according to Pederson scale.
排除标准
- •The exclusion criteria are
- •refuse to participate in the study,
- •failure to attend 24, 48, and 72 hours, as well as, 7 days post-surgical appointment visits,
- •systemic diseases as diabetes mellitus or being immunosuppressed,
- •patients who take local or systemic antibiotics less than 3 months ago, anti-inflammatory or anticoagulant medication in the previous 4 weeks,
- •patients who require antibiotic prophylaxis,
- •pregnant or breastfeeding women,
- •patients with chronic periodontitis in active phase or
- •with history of allergies to any of the components of local anaesthetics, antibiotics, AINEs, or NBF gingival gel.
研究组 & 干预措施
NBF
Propolis Extract, Ascorbic Acid, Tocopherol Acetate, Sodium-Monofluorophosphate, Silicon Dioxide, Glycerin, D-sorbitol, Polyethyleneglycol 150, Sodium Carboxymethylcellulose, Xylitol, Sterol Glycoside, Peppermint Oil, L-Menthol, Methyl Hydroxybenzoate and Deionized Water
干预措施: NBF (Drug)
Placebo
Sodium-Monofluorophosphate, Silicon Dioxide, Glycerin, D-sorbitol, Polyethyleneglycol 150, Sodium Carboxymethylcellulose, Xylitol, Sterol Glycoside, Peppermint Oil, L-Menthol, Methyl Hydroxybenzoate and Deionized Water
干预措施: Placebo (Device)
结局指标
主要结局
Alveolar Osteitis: intense neuralgic pain in the post-extraction socket in the second or third postoperative day that do not disappear with analgesics beside a partially or totally disintegrated clot
时间窗: from baseline to 24, 48, 72 hours post intervention
yes or no
次要结局
- Swelling: it was evaluated with a flexible metric tape measuring the facial perimeter from trago to pogonion. A first measurement was made before surgery, which was compared with the measurements taken at 24, 48 and 72 hours of the extraction.(from baseline to 24, 48, 72 hours and 7 days post intervention)
- Trismus: it was assessed measuring the maximum opening from the inter incisive points.(from baseline to 24, 48, 72 hours and 7 days post intervention)
- Wound healing: it was assessed with a semi-quantitative scale (good, satisfactory or insufficient).(from baseline to 1 week post intervention)
- Post extraction pain: it was recorded using a visual analog scale, ranging from 0 (no pain) to 10 (the worst pain imaginable) at 9 pm of 7 consecutive days.(from baseline to 1 week post intervention)
- Number of rescue analgesic pills consumption: recorded for the first 3 days by the patients.(from baseline to 3 days post intervention)
研究者
Rosa María López-Pintor Muñoz
Associate professor
Universidad Complutense de Madrid