Nd:YAG Laser Versus Diode Laser Assisted New Attachment Procedure (Lanap) in the Management of Stage II Periodontitis: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Clinical attachment loss (CAL)
研究概览
简要总结
Aim of the study was to assess and compare the clinical and microbiological changes following Laser assisted new attachment procedure (LANAP®) using diode 940 nm versus ND:YAG 1064 nm, and to compare the outcome to conventional periodontal therapy
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periodontal diagnosis of stage II periodontitis.
- •Residual periodontal pocket ≥4 mm, 3-4 mm clinical attachment loss with horizontal bone loss higher than 15% in radiography.
- •O'Leary plaque index <10%.
排除标准
- •Patients with furcation involvement.
- •Class II/III tooth mobility.
- •Smokers who smoke more than 10 cigarettes per day.
- •Patients with any systemic condition possibly affecting the outcome of periodontal therapy.
- •Patients who had received any local or systemic anti-inflammatory medications or antibiotics within the last 6 months.
- •Alcohol consumers.
- •Pregnant or lactating women.
- •Patients with parafunctional habits.
研究组 & 干预措施
LANAP surgical protocol using ND:YAG 1064 laser
干预措施: LANAP surgical protocol using ND:YAG 1064 laser (Device)
LANAP surgical protocol using diode 940 laser
干预措施: LANAP surgical protocol using diode 940 laser (Device)
Scaling and root planing
干预措施: Scaling and root planing (SRP) (Procedure)
结局指标
主要结局
Clinical attachment loss (CAL)
时间窗: up to six months
This is assessed using a Williams probe from a fixed reference point on the crown to the base of the pocket. Pocket severity is classified by the extent of clinical attachment loss in millimeters (0= normal, 1 or 2 mm = slight, 3 or 4 mm = moderate, ≥ 5 mm = severe).
Pocket probing depth (PPD)
时间窗: up to six months
This is measured from the margin of the gingiva to the base of the pocket using a Williams probe. The normal probing sulcus depth is considered to range from 1 to 3 mm in healthy gingiva.
Microbiological assessment of Treponima denticola
时间窗: up to six months
Sub-gingival dental plaque biofilm will be collected using size 50 paper point after ensuring a good isolation of the operating field, and sample will be placed in sterile microcentrifuge tubes containing phosphate buffered saline to be transferred immediately to the Microbiology Laboratory of Alexandria University Hospitals. Microcentrifuge tubes will be vortexed for 5 minutes then 200 ul of resulting suspension will be subjected to DNA extraction using QIAamp DNA Minikit (Qiagen, Germany). Specific PCR primers targeting gingival plaque-associated oral microbiota (Treponima denticola Td) will be used in SYBER green real-time PCR. Amplification of the 16SrRNA gene will be used as the denominator against which the amplification of other bacteria will be estimated. The bacterial relative quantification will be calculated automatically by Rotor-gene software and expressed as relative fold difference.
Microbiological assessment of Prevotella intermedia
时间窗: up to six months
Sub-gingival dental plaque biofilm will be collected using size 50 paper point after ensuring a good isolation of the operating field, and sample will be placed in sterile microcentrifuge tubes containing phosphate buffered saline to be transferred immediately to the Microbiology Laboratory of Alexandria University Hospitals. Microcentrifuge tubes will be vortexed for 5 minutes then 200 ul of resulting suspension will be subjected to DNA extraction using QIAamp DNA Minikit (Qiagen, Germany). Specific PCR primers targeting gingival plaque-associated oral microbiota (Prevotella intermedia Pi) will be used in SYBER green real-time PCR. Amplification of the 16SrRNA gene will be used as the denominator against which the amplification of other bacteria will be estimated. The bacterial relative quantification will be calculated automatically by Rotor-gene software and expressed as relative fold difference.
Gingival health
时间窗: up to six months
The gingival index (Löe and Silness,1967) will be used to assess the degree of gingival inflammation. Each tooth is examined and scored (0-3), where 0 = normal gingiva; 1 = mild inflammation: slight change in color, slight edema, no bleeding on probing; 2 = moderate inflammation: redness, edema, and glazing, or bleeding on probing; 3 = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding and ulceration
次要结局
未报告次要终点
研究者
Nada Shaban
Master's candidate of Periodontology
Alexandria University
