Comparative evaluation of effectiveness of herbal dressing containing vitamin C and banana peel extract with COE PAK after gingival depigmentation procedure: a Ramdomised controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The Dummett Oral Pigmentation Index (DOPI) is used to measure the intensity of gingival pigmentation
研究概览
简要总结
The study will comprise of 25 patients (50 sites) visiting the Department of Periodontology and Implantology, exhibiting gingival hyperpigmentation. Sides will be assigned randomly for each of the treatment groups.
The study will be conducted in Department of Periodontology and Implantology, after taking informed consent from the patient. All the clinical parameters will be evaluated at baseline after which the sitesin the patients will be randomly divided into Group I and Group II.
Prior to the study, study protocol will be explained to the patients and a written informed consent will be obtained.
The study will be initiated after the clearance from the Institutional Ethics Committee.
Surgical Procedure:
Preoperative intraoral therapy and assessment of complete medical, family history, and blood investigations will be carried out to exclude any surgical contraindication and confirm the diagnosis of gingival pigmentation. Under local anesthesia gingival depigmentation will be carried out in the maxillary or mandibular aesthetic areas, from the canine/1st premolar region to contralateral similar tooth region, with scalpel procedure.
Clinical photographs, DOPI index, and Dermascopic examination will be taken for gingival pigmentation at baseline and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy participants with gingival melanin hyperpigmentation.
- •Moderate to heavy melanin pigmentation in patient in the anterior gingiva from canine to canine (esthetic zone) according to Dummett oral pigmentation index.
排除标准
- •Participants with any systemic diseases, especially those having healing problems, such as uncontrolled diabetes and auto-immune disease 2.Tobacco smokers 3.Pregnant women 4.Pathological gingival hyperpigmentation, including Addison’s disease, neurofibromatosis, oral melanotic maculae, oral mucosal melanoma, and drug-induced oral mucosal pigmentation.
结局指标
主要结局
The Dummett Oral Pigmentation Index (DOPI) is used to measure the intensity of gingival pigmentation
时间窗: BASELINE AND 6 MONTHS
2. Dermascopic examination of melanocyte patterns
时间窗: BASELINE AND 6 MONTHS
次要结局
- VAS scale is used to measure pain intensity or other subjective characteristics(Landry’s Healing Index is used to assess the progress of wound healing)
研究者
Dr. Roshni Valecha
Ranjeet Deshmukh Dental College, Nagpur