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临床试验/NCT06358937
NCT06358937招募中不适用

Clinical and Microbiological Evaluation of Laser Assisted New Attachment Procedure (LANAP) Using Nd:Yag vs. Diode Laser in the Management Of Stage II Periodontitis (Randomized Controlled Clinical Trial)

Mahmoud Salem1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
27
试验地点
1
主要终点
Microbiological assessment of Porphyromonas gingivalis

研究概览

简要总结

The aim of the present study is to compare the efficacy of LANAP to conventional scaling and root planing in the management of stage II periodontitis.

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
Single (Participant)

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

  • Patients with stage II generalized periodontitis PPD ≥ 5 mm with attachment loss 3-4 mm with horizontal bone loss

排除标准

  • Patients with vertical bone loss or furcation involvement.
  • History of smoking more than (10 cigarettes / day).
  • Patient with medical condition that contraindicate surgical procedures.
  • Patients receiving antibiotics in the past three months prior to the procedure.
  • Pregnant or lactating females.

结局指标

主要结局

Microbiological assessment of Porphyromonas gingivalis

时间窗: up to 6 months

Subgingival plaque biofilm will be collected using paper cone after making a good isolation of the operated field and put into a sterile microcentrifuge tube containing phosphate buffered saline to be transferred immediately to the Microbiology laboratory for analysis of microbiome. Microcentrifuge tubes will be vortexed for 5 minutes then 200 ul of the resulting suspension will be subjected to DNA extraction using QIAamp DNA minikit. Specific PCR primers targeting gingival plaque associated oral microbiota (Porphyromonas gingivalis) will be used in SYBR Green Real-Time PCR. Amplification of 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 the Rotor-Gene software and expressed as relative fold difference.

Microbiological assessment of Fusobacterium nucleatum

时间窗: up to 6 months

Subgingival plaque biofilm will be collected using paper cone after making a good isolation of the operated field and put into a sterile microcentrifuge tube containing phosphate buffered saline to be transferred immediately to the Microbiology laboratory for analysis of microbiome. Microcentrifuge tubes will be vortexed for 5 minutes then 200 ul of the resulting suspension will be subjected to DNA extraction using QIAamp DNA minikit. Specific PCR primers targeting gingival plaque associated oral microbiota (Fusobacterium nucleatum) will be used in SYBR Green Real-Time PCR. Amplification of 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 the Rotor-Gene software and expressed as relative fold difference.

Microbiological assessment of Tannerella forsythia

时间窗: up to 6 months

Subgingival plaque biofilm will be collected using paper cone after making a good isolation of the operated field and put into a sterile microcentrifuge tube containing phosphate buffered saline to be transferred immediately to the Microbiology laboratory for analysis of microbiome. Microcentrifuge tubes will be vortexed for 5 minutes then 200 ul of the resulting suspension will be subjected to DNA extraction using QIAamp DNA minikit. Specific PCR primers targeting gingival plaque associated oral microbiota (Tannerella forsythia) will be used in SYBR Green Real-Time PCR. Amplification of 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 the Rotor-Gene software and expressed as relative fold difference.

次要结局

  • Probing depth(up to 6 months)
  • Clinical attachment loss(up to 6 months)
  • Plaque index(up to 6 months)
  • Gingival index(up to 6 months)

研究者

发起方
Mahmoud Salem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mahmoud Salem

Master's candidate of Periodontology

Alexandria University

研究点 (1)

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