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临床试验/NCT06509412
NCT06509412已完成不适用

Nd:YAG Laser Versus Diode Laser Assisted New Attachment Procedure (Lanap) in the Management of Stage II Periodontitis: Randomized Controlled Clinical Trial

Nada Shaban1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: LANAP surgical protocol using ND:YAG 1064 laser (Device)

LANAP surgical protocol using diode 940 laser

Experimental

干预措施: LANAP surgical protocol using diode 940 laser (Device)

Scaling and root planing

Active Comparator

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

发起方
Nada Shaban
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nada Shaban

Master's candidate of Periodontology

Alexandria University

研究点 (1)

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