Comparison of depigmentation using 980 nm diode LASER and Cryosurgery: A split mouth controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- gingival pigmentation will be accessed using Dummett Gupta Oral Pigmentation Index in anterior region in both the arches. RGB red green blue values will also be accessed
研究概览
简要总结
This study will be an observational , comparative, clinical trial which will be carried out on 34 sites of hyperpigmented anterior maxillary gingiva by split mouth technique, operated by a single examiner.
Selection of patient’s site for depigmentation will be as followed-
i)Site A- Maxillary anterior right sexant - using LASER
ii)Site B- Maxillary anterior left sexant - using Cryosurgery
All the subjects will be recalled after 24 hrs to evaluate any uneventful soft tissue changes. Clinical parameters like OHI-S, GI, PI and clinical photographs will be recorded at baseline and 1, 3 months postoperatively. Appearance of melanin pigmentation will be measured clinically at baseline and at 1 and 3 months post operatively and also analysed by photometric analysis using ImageJ software. All the other clinical parameters recorded at specific time interval will be subject for data analysis. Student t- test (unpaired/ independent t-test) where p is equal to or less than 0.05 denoted at level of clinical significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group between 20-35yrs.
- •Both the genders will be considered.
- •Subjects with good oral hygiene.
- •Moderate to heavy physiological gingival hyperpigmentation (Dummett-Gupta,1964).
排除标准
- •Subjects with systemic diseases associated with pathological hyperpigmentation.
- •Improper wound healing.
- •Allergic to local anaesthesia, antibiotics and analgesics.
- •Untreated periodontal disease.
- •Pregnant and lactating women.
- •Subjects who are already wearing prosthesis.
- •Non compliant patients.
- •Subjects with substance abuse.
结局指标
主要结局
gingival pigmentation will be accessed using Dummett Gupta Oral Pigmentation Index in anterior region in both the arches. RGB red green blue values will also be accessed
时间窗: baseline and 3 months post operative
次要结局
未报告次要终点
研究者
Dr LEENA HARI
Hazaribag college of dental sciences and hospital