EVALUATION AND COMPARISON OF THE EFFECTIVENESS OF SUGAR FREE CHEWING GUM V/S TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) IN MOUTH OPENING AND SALIVARY FLOW RATE IN PATIENTS WITH OSMF – A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To evaluate the increase in mouth opening and salivary flow rate in patients with Submucous Fibrosis also to check the burning mouth and altered taste sensation.
研究概览
简要总结
Introduction - The most common chronic condition and potentially malignant disorder of oral mucosa is Oral sub mucous fibrosis (OSMF). The signs and symptoms of OSMF include blanching of the oral mucosa, burning sensation of the oral mucosa, reduced mouth opening, palpable fibrous bands which involves buccal mucosa, labial mucosa, tongue, floor of mouth and soft palate. A fibrous band that restricts mouth opening (trismus) is a characteristic feature.
Sugar free chewing gum can increase mouth opening and salivary flow rate when compared with trans cutaneous electrical nerve stimulation.
A randomized controlled trial will evaluate and compare sugar free chewing gum and transcutaneous nerve stimulation for increasing mouth opening and salivary flow rate.
Primary objective -
| To evaluate the effectiveness of Sugar Free Chewing Gum vs TENS in patients with Oral Submucous Fibrosis with reduced mouth opening, decrease in salivary flow rate, burning mouth and altered taste sensation. |
Secondary objective - To compare the effectiveness of Sugar Free Chewing Gum vs TENS in patients with Oral Submucous Fibrosis with reduced mouth opening, decrease in salivary flow rate, burning mouth and altered taste sensation.
Methodology - Group A (32 patients) will be given intralesional therapy along with Sugar Free Chewing Gum and mouth opening exercises for a period of 3 months.
Group B (32 patients) will be given Intralesional therapy giving Inj. Dexamethasone4mg/ml, Hyaluronidase 1500 IU and 2%Lignocaine 2ml along with TENS and mouth opening exercises for a period of 3 months.
Evaluation will be done at baseline , after 1 month , after 2 months and after 3 months of follow up.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Oral submucous fibrosis stage II according to Chandramani More et al 2011 Classification Patients those are willing to participate.
排除标准
- •Patients with Oral submucous fibrosis stage I,III,IV Patients with History of systemic disease and taking medications for the same.
- •Patients less than 18 years of age.
- •Patients having oral submucous fibrosis without oral burning sensation and altered taste perception.
结局指标
主要结局
To evaluate the increase in mouth opening and salivary flow rate in patients with Submucous Fibrosis also to check the burning mouth and altered taste sensation.
时间窗: baseline, after 1 month, after 2 months, after 3 months
次要结局
- To compare the increase in mouth opening and salivary flow rate in patients with Submucous Fibrosis also to check the burning mouth and altered taste sensation with Sugar free chewing gum and transcutaneous electrical nerve stimulation(baseline, after 1 month, after 2 months, after 3 months)
研究者
Dr Ajita Mehendale
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna , Nagpur