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临床试验/CTRI/2024/05/067868
CTRI/2024/05/067868已完成2/3 期

Comparative Analysis of Periapical Healing with Human Amniotic Membrane, Hydroxyapatite Graft and Laser Biostimulation in Peri Radicular Surgery Cases-A CBCT Study

ITS Dental College Hospital And Reseach Centre1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年6月17日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
To evaluate and compare periapical healing after endodontic surgeries using Human Amniotic Membrane, hydroxyapatite graft and Laser Biostimulation using CBCT.

研究概览

简要总结

This study will be done to evaluate the healing after periapical surgery in the patients having periapical lesion not more than 10mm.The forthcoming in vivo study will be carried out within the department of conservative dentistry and endodontics at ITS dental college and research centre in greater Noida, uttarpradesh.

A clinical diagnosis for the patient reporting to the department of conservative dentistry and endodontics will be made and 24 patients age18 to 40 years will be selected by the inclusion and exclusion criteria. Included patient will then be informed about the study and explained in detail about the procedure. A preoperative CBCT will be taken to assess the size of periapical radiolucency

Patient will then be divided randomly to the following groups.

Group1- 8 patients with periapical lesion, laser biostimulation will be done after peri apical surgery

Group 2- 8 patients with periapical lesion, human amniotic membrane will be placed along with laser biostimulation after peri apical surgery.

Group3- 8 patients with periapical lesion, hydroxyapatite bone graft will be placed along with laser biostimulation after peri apical surgery.

Root canal treatment will be performed in relation to all the effected teeth.

Under proper isolation, the root canals will be obturated using gutta percha and

AH plus sealer prior to the surgery. A radiograph will be taken to assess the root canal treatment.

Surgical intervention will be facilitated using a crevicular incision aided with a unilateral posterior release after thorough anesthesia will be attained using 2% lignocaine.

The reflection of the full thickness mucoperiosteal flap, a bony window will be created through the cortical bone. This facilitated access to the cystic lining and the granulation tissue, which will be carefully curetted and will be sent for biopsy.

Residual inflammatory connective tissue will be curetted, the root ends will be resected. Root end cavities will be prepared with low-speed bur and filled with MTA as a retrograde filling material. The surgical area will be thoroughly irrigated and isolated.

The area will be packed with hydroxyapatite graft or human amniotic membrane

(depending on the respective group) followed by laser biostimulation.

Hemostasis will be achieved and the mucoperiosteal flap will be sutured back to its original anatomical position with 4-0 silk sutures.

Necessary post-operative instructions will be advised, and the patient will be prescribed antibiotics and analgesics.

Proper plaque control will be emphasized with the use of 0.2% chlorhexidine gluconate mouthwash twice daily for at least 2 weeks. A post-surgical visit after one week to check any adverse effects or any allergic reactions to the material.

VAS scale will be used to score the discomfort immediate post-operatively

and at the recall visit after a week.

The patient will be recalled at 3, 6, and 12-months interval.

Radiographs will be taken to assess the bone healing in the periapical region.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • 1.18 to 40 years of age 2.Teeth with Periapical Radiolucency indicated for surgery.
  • 3.Patient not on any medication affecting periapical healing.
  • (Corticosteroids, chemotherapeutic agents, Anticoagulants, drugs which reduce osteoclastic activity.) 4.Noncontributory medical history (ASA I & II).
  • 5.Single rooted anterior teeth with intact palatal/lingual bone.
  • 6.Lesion size less than 10 mm.

排除标准

  • 1.Pregnant females 2.Patient with periodontally compromised teeth.
  • 3.Patient having insufficient motivation to report back for follow ups.
  • 5.Lesion size greater than 10 mm.
  • 6.Vertical root fracture.

结局指标

主要结局

To evaluate and compare periapical healing after endodontic surgeries using Human Amniotic Membrane, hydroxyapatite graft and Laser Biostimulation using CBCT.

时间窗: Periapical healing will be evaluated at the time interval of baseline,3 months, 6 months and 12 months interval.

次要结局

  • To find out which group among human amniotic membrane, hydroxyapatite graft And laser biostimulation will give the best healing outcome after endodontic surgeries.(At the baseline, 3 months, 6 months And 12 months interval.)

研究者

发起方
ITS Dental College Hospital And Reseach Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Rajat Shukla

ITS Dental College Hospital And Reasearch Centre, Greater Noida

研究点 (1)

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