Comparative Evaluation of Hemolasertherapy with and without injectable platelet rich fibrin in papillary reconstruction-A Randomised clinical trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- to compare the interdental papillary gain.
研究概览
简要总结
AIM: The aim of the present study to compare and evaluate the effect of hemolasertherapy alone and hemolasertherapy in combination with injectable platelet rich fibrin for papillary regeneration.
All the participants will be explained about the aim ,nature and design of study along with a written informed consent for their participation before the commencement of the study.
This study is planned as a randomized clinical trial conducted in healthy individuals with anterior interdental papillary loss. The study duration is 6 months in which clinical parameters will be recorded at baseline,1,6 months.
All the patients included in study will be evaluated before the treatment procedure and patients with anterior interdental papillary loss in either maxilla or mandible are selected.
PREPARATION OF INJECTABLE PLATELET RICH FIBRIN:Before the procedure ,a venous blood sample will be collected for each patient using a syringe and taken into I-PRF tubes of 10ml containing no anticoagulants and will be centrifuged at room temperature for3min at 700rpm.
HEMOLASERTHERAPY: applied with a diode laser in 2 stages :before bleeding and immediately after bleeding. bleeding points were marked on gingiva with a tissue marker . 3 points per tooth and a point between labial and lingual papilla.
each spot was irradiated with 980nm diode laser at a power setting 100mW FOR 20SECONDS/ maximum energy of 20J per point. At the base of papilla , fiber tip was inserted approximately 3-4mm into interdental papilla and irrradiated at the same poweer setting. pricks were made on goingiva with explorer tip on every bleeding point marked. The blood was allowed to flow into the sulcus and interdental embrassure,then irradiated with same power setting.
HEMOLASERTHERAPY + INJECTABLE PLATELET RICH FIBRIN: After hemolasertherapy procedure is completed in keratinizedtissue, injectable platelet rich fibrin will be injected into interdental papilla.
The clinical measurements of patients will be taken once at baseline then after 1month and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-50 years.
- •Patients with class1 and class2 [Nordland and Tarnow Classificatioin] anterior interdental papillary loss.
- •Non-Smoker patients.
- •Plaque and gingival index score between 0-
- •Pateints who are co-operative and able to come for regular checkup.
排除标准
- •patients with bleeding gums and edematous gums.
- •patients with systemic diseases.
- •consumption of drugs causing gingival hyperplasia.
- •patients with periodontal pocket.
- •patients with caries,proximal restoration,fixed prosthesis and orthodontic appliance.
结局指标
主要结局
to compare the interdental papillary gain.
时间窗: baseline,1month and 6months
次要结局
- plaque index(sillness &loe,1964)(gingival index(loe &sillness 1963))
研究者
RUPAVATH SUPRIYA
Narayana Dental College and Hospital