Effect of Salvadora Persica on Clinical, Radiographic and Microbiological Parameters of Chronic Periodontitis: A Triple-Blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 66
- 主要终点
- clinical attachment level
研究概览
简要总结
A randomized controlled triple blinded study to evaluate the effectiveness of Salvadora Persic (SP) as an adjunct to Scaling and Root Planing (SRP) in chronic periodontitis by comparing the basic parameters of periodontitis, radiographs and bacterial levels with a controlled group (SRP only).
详细描述
Sixty-six subjects with untreated, moderate-to-severe chronic periodontitis will be selected by convenience sampling. The participants will be randomly divided into 2 groups:
- Test group: SRP + SP gel
- Control group: SRP only
Each participant will undergo treatment in the following steps:
- QUESTIONNAIRE:
All participants will complete a structured baseline questionnaire provided by one trained interviewer that will include the data regarding; (a) age; (2) gender; (3) education status; (4) occupation; (5) medical status 2. INFORMED CONSENT:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are >30 years old
- •Minimum of 20 teeth , excluding third molars
- •Systemically healthy patients with moderate (PD of 5 to 6 mm or clinical attachment loss CAL of 4 to 6 mm) or deep pockets (PD ≥7mm or CAL of 6 to 9 mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs (Armitage 1999)
排除标准
- •Presence of systemic conditions that could modify the progression of periodontitis such as diabetes mellitus, metabolic syndrome, cardiovascular disease or immunologic disorders
- •Systemic antimicrobials in the previous 6 months
- •Aggressive periodontitis
- •Pregnancy or lactation
- •Inability to provide informed consent
研究组 & 干预措施
SRP plus salvadora persica root
Subjects receiving salvadora gel in addition to scaling and root planing
干预措施: Salvadora Persica Root (Drug)
SRP plus salvadora persica root
Subjects receiving salvadora gel in addition to scaling and root planing
干预措施: Scaling and root planing (Procedure)
SRP only
Subjects receiving scaling and root planing only
干预措施: Scaling and root planing (Procedure)
结局指标
主要结局
clinical attachment level
时间窗: 3 months
Clinical attachment level (CAL) is the distance from the cemento-enamel junction to the base of the sulcus. It will be measured by a calibrated examiner who will use a UNC 15 probe at 6 points around each tooth. The measurements will be expressed as the nearest millimeters and will be entered into the advanced periodontal chart.
periodontal pocket depth
时间窗: 3 months
Probing depth (PD) is defined as the distance from the gingival margin to the base of the pocket/sulcus.It will be measured by a calibrated examiner, using a UNC 15 probe and expressed in millimetres. The value will be entered into the periodontal chart provided with the questionnaire.
bleeding on probing
时间窗: 3 months
presence or absence of bleeding on probing within 10 seconds around 6 points along each tooth. Presence of bleeding will be marked as 1, while absence will be marked as 0.
plaque index
时间窗: 3 months
presence of absence of plaque along 6 points around each tooth will be examined and entered in the periodontal chart. SItes showing plaque will be marked as 1, while those not showing plaque will be marked as 0.
次要结局
- intrabony defects(3 months)
- Porphyramonas gingivalis level(3 months)
研究者
Zohaib Akram
Senior Registrar
King Saud University