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临床试验/CTRI/2024/07/070472
CTRI/2024/07/070472尚未招募3 期

Effects of Professional Mechanical Plaque Removal and Human Placental Extract on Gingival Crevicular Fluid levels of Matrix Metalloproteinase-8 in Patients with Stage II Grade A/B Periodontitis

Tamil Selvan M D1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
Reduction in Probing Pocket Depth and Gain in Clinical attachment levels

研究概览

简要总结

Out Patients reporting to Department of Periodontics and Implantology, Adhiparasakthi

Dental College and Hospital aged between 20-45 years diagnosed with Localised Stage II Grade A/B Periodontitis and meeting the inclusion and exclusion criteria will be included for the study.The nature of the study and the procedure will be explained to the patient in the vernacular language and written informed consent will be obtained from the patients who are willing to participate.

Following the sample selection, the Sites will be randomly assigned to either the Test group(Group A) or the Control group(Group B).

In Group A patients, Clinical parameters including Gingival index, Plaque index, Probing Pocket depth & Clinical attachment level were recorded using UNC 15 probe at baseline.

Probing will be conducted at six sites around the tooth. The sites exhibiting the deepest PD and the greatest CAL will be chosen, and the same site will be considered during subsequent follow-up visits. At baseline, GCF collection will also be done. The selected test site will be air-dried and isolated using sterile cotton rolls. Supragingival plaque will

be removed gently without touching the marginal gingiva to prevent bleeding from gingiva. By using an extracrevicular (unstimulated) method, a standardised volume of 3μL of GCF will be collected from the selected site with a 1-5 μL calibrated volumetric microcapillary pipette. The collected GCF will be transferred to eppendorf tubes containing 0.5 mL of phosphate buffer saline and stored at -70 °C until the time of assay. Only the samples devoid of visible contamination with blood or plaque will be considered for the study. After the baseline (D0) GCF sampling and clinical parameter recording, a patients will undergo

thorough ultrasonic supragingival and subgingival mechanical plaque removal using Ultrasonic scaler(Woodpecker) and hand instruments (Hufriedy Universal curette 2R/2L,4R/4L) followed which 1ml of human placental extracts gel (Placentrex – the original research product of Albert David Limited, India, a drug obtained from fresh term healthy human placentae) adsorbed in gelatin foam will be placed in the Pocket. Post

Operative instructions will be given.

In Group B patients, Clinical parameters(Gingival index, Plaque index, Probing Pocket depth & Clinical attachment level) will be recorded using UNC 15 probe at baseline at the

selected site. At the selected tooth, probing was done at six sites. The sites that showed the deepest PD and the greatest CAL were chosen, and the same site was considered during follow-up visits. At baseline, GCF collection will also be done. The selected test site will be air-dried and isolated with sterile cotton rolls. Supragingival plaque will be removed gently without touching the marginal gingiva to prevent bleeding from gingiva. Utilising

an extracrevicular (unstimulated) method, a standardised volume of 3 μL of GCF will be

collected from the selected site with a 1-5 μL calibrated volumetric microcapillary pipette. The collected GCF will be transferred to eppendorf tubes containing 0.5 mL of phosphate buffer saline and promptly stored at -70 °C until the time of assay. Only the samples devoid of visible contamination with blood or plaque were considered for the study. After the baseline (D0) GCF sampling and clinical parameter recording, patients will undergo only thorough ultrasonic supragingival and subgingival mechanical plaque removal with Ultrasonic scaler(Wood Pecker) and hand instruments (Hu-friedy Universal curette

2R/2L,4R/4L).

Oral hygiene instructions will be given to the patients.

Recall appointments will be scheduled after 2months for follow-up. During the recall visit, GCF sampling and clinical parameter recordings will be repeated.GCF samples will be analysed for MMP8 levels using ELISA MMP8 assay Kit.

Recorded Clinical data and analysed GCF MMP 8 levels will be tabulated and subjected to statistical analysis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.Age: 20-45 years 2.Presence of 20 or more natural teeth 3.Localised Stage I/II Grade A/B Periodontitis(AAP 2017) [Presence of localised Supra bony pocket of 4-6mm].

排除标准

  • 1.Patients with Systemic illness 2.Patients with Molar/Incisor pattern Periodontitis 3.Pregnant and Lactating women 4.Patients using Smoking and Smokeless tobacco 5.Patient under local or systemic antibiotic or anti inflammatory therapy in past 3 months.

结局指标

主要结局

Reduction in Probing Pocket Depth and Gain in Clinical attachment levels

时间窗: Baseline and 2 Months

次要结局

  • Improvement in Gingival index & Plaque Index scores(Baseline & 2 Months)

研究者

发起方
Tamil Selvan M D
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Tamil Selvan M D

Adhiparasakthi Dental College and Hospital

研究点 (1)

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