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临床试验/CTRI/2023/10/058222
CTRI/2023/10/058222尚未招募2 期

Assessment of wound healing using different tissue regeneration materials in mandibular tooth extraction - A Prospective Study

Dr. Rajesh P1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年5月10日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Pain, inflammation and infection using Landry’s wound healing scale.

研究概览

简要总结

The aim of the study is to Compare analyse wound healing in extraction socket using platelet-rich plasma fibrin with or without platelet rich fibrin based nanocomposite. Patients who visited the department of oral and maxillofacial surgery, chettinad dental college and research institute, will be screened and patients indicated for tooth extraction according to the inclusion and exclusion criteria will be selected for the study and randomly grouped into 9 different groups with 10 each such as Group 1: control group Group 2 : Platelet rich fibrin (PRF) Group 3: PRF + Silver nanoparticles Group 4: PRF + Titanium nanoparticles Group 5: PRF + Chitosan nanoparticles Group 6: PRF + Silver nanoparticles + Titanium nanoparticles Group 7: PRF + Silver nanoparticles + Chitosan nanoparticles Group 8 : PRF + Titanium nanoparticles + Chitosan nanoparticles Group 9 : PRF + Silver nanoparticles + Chitosan nanoparticles + Titanium nanoparticles Extraction of mandibular teeth will be done for all the subjects under local anaesthesia followed by a tissue regeneration material. A follow up of the patient will be done on the 3rd day, 7th day, 6 weeks. The extraction site will be assessed for pain, inflammation and infection. Landry’s wound healing scale will be used to assess the healing process. IPR scale will aso be used to assess the healing at the inflammatory, proliferative and remodelling phases of wound healing. This will be done at the 3rd day corresponding to inflammatory phase, 7th day corresponding to the proliferative phase and after 6 weeks corresponding to the remodeling phase. In the study, appreciable amount of bone regeneration is expected to be observed in the experimental groups when compared to the control sites where no PRF was used. All the procedures performed in the study involves no risk or harm to the study population and complies with the ethical standards

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • •Extraction of permanent mandibuar molar teeth performed for several reasons including dental caries, periodontal disease, failed dental treatment, prosthetic indications and other reasons.

排除标准

  • •Teeth which can be save endodontically patient with systemic complication Patient with bleeding disorders Patients with Bone disorders.

结局指标

主要结局

Pain, inflammation and infection using Landry’s wound healing scale.

时间窗: 3rd day, 7th day, 6th week and 12th week

次要结局

  • IPR scale will aso be used to assess the healing at the inflammatory,(proliferative and remodelling phases of wound healing)

研究者

发起方
Dr. Rajesh P
申办方类型
Other [self]

研究点 (1)

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