Comparative evaluation of local drug delivery of doxycycline with a novel vehicle injectable-platelet rich fibrin versus doxycycline gel as an adjunct to nonsurgical periodontal therapy in periodontitis: a randomized controlled clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pocket Probing Depth
研究概览
简要总结
AIM- The aim of the study is to evaluatethe use of doxycycline with I-PRF as a LDD vehicle
PRIMARY OBJECTIVE:
To evaluate the efficacy of locally delivered doxycycline with I-PRF as a vehicle versus locally delivered doxycycline gel as an adjunct to non-surgical periodontal therapy in periodontitis.
SECONDARY OBJECTIVES:
1.To assess the clinical efficacy of doxycycline with IPRF as a local drug delivery vehicle as an adjunct to non-surgical periodontal therapy in periodontitis.
2.To assess the clinical efficacy of doxycycline gel as an adjunct to non -surgical periodontal therapy in periodontitis.
3.To assess and compare the clinical efficacy of locally delivered Doxycycline with IPRF as a vehicle and locally delivered doxycycline gel as an adjunct to non- surgical periodontal therapy in periodontitis
INCLUSION CRITERIA
1.Individuals above 18 years of age.
- A minimum of 20 natural teeth present
3.Systemically healthy patients diagnosed with periodontitis
- Patients having pocket probing depth of 4-6 mm.
Diagnosis: Stage II (Grade A, Grade B), Stage III (Grade A, Grade B)
According To Classification of Periodontal Diseases 2017)
- Only patients agreeing to give consent are included.
EXCLUSION CRITERIA
1.Individuals using any form of alcohol and tobacco.
2.Individuals who have used antibiotics, probiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 3-months.
3.Individuals with systemic diseases.
4.Lactating and/or pregnant females.
METHODS OF MEASUREMENT:
Clinical procedure:
1ST Visit
1.Patients satisfying the inclusion criteria will be selected.
2.Thorough scaling and root planing will be done for all patients.
- Oral hygiene measures instructed to the patients.
2nd Visit
- Patients will be recalled after 21 days and this visit will be considered as baseline.
2.Clinical parameters will be assessed.
3.Informed consent from the subject will be obtained.
- At this visit, detailed medical, dental histories as well as periodontal examination will be recorded.
5.Patients will be randomly allotted in Group A and Group B by lottery method.
- Local drug will be delivered.
3rd visit
1.Patients will be recalled after 6 weeks for follow-up and clinical parameters will be assessed.
4th visit
1.Patient will be recalled after 12 weeks for follow-up
2.Patient’s clinical parameters will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Individuals above 18 years of age.
- •A minimum of 20 natural teeth present 3.Systemically healthy patients diagnosed with periodontitis
- •Patients having pocket probing depth of 4-6 mm.
- •Diagnosis: Stage II (Grade A, Grade B), Stage III (Grade A, Grade B) According To Classification of Periodontal Diseases 2017)
- •Only patients agreeing to give consent are included.
排除标准
- •1.Individuals using any form of alcohol and tobacco.
- •2.Individuals who have used antibiotics, probiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 3-months.
- •3.Individuals with systemic diseases.
- •4.Lactating and/or pregnant females.
结局指标
主要结局
Pocket Probing Depth
时间窗: Pocket Probing Depth | Mild: 0-3mm | moderate: 3-6mm | Severe:more than 6mm
Mild: 0-3mm
时间窗: Pocket Probing Depth | Mild: 0-3mm | moderate: 3-6mm | Severe:more than 6mm
moderate: 3-6mm
时间窗: Pocket Probing Depth | Mild: 0-3mm | moderate: 3-6mm | Severe:more than 6mm
Severe:more than 6mm
时间窗: Pocket Probing Depth | Mild: 0-3mm | moderate: 3-6mm | Severe:more than 6mm
次要结局
- Clinical Attachment Levels(6 weeks and 12 weeks)
研究者
Dr Sakshi Aglawe
Yogita Dental College and Hospital