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临床试验/NCT07391384
NCT07391384尚未招募不适用

Evaluation of the Effect of Thymoquinone Hydrogel With Bone Graft in Comparison to Bone Graft Only Around Immediate Implant (Randomized Controlled Clinical Trials)

shaimaa hamdy0 个研究点目标入组 44 人开始时间: 2026年1月21日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
44
主要终点
primary stability

研究概览

简要总结

use of Thymoquinone hydrogel with bone graft in comparison to bone graft only around immediate implant-this hydrogel fill the jumping zone in comparison to using hydrogel bone graft only to increase primary stability and enhance osseointegration

详细描述

Immediate dental implant placement has gained popularity for replacing extracted teeth due to its advantages, including shorter treatment time, better preservation of alveolar bone volume, and enhanced aesthetic outcomes. However, the success of immediate implants largely relies on achieving optimal osseointegration, defined as the direct structural and functional bond between living bone and the surface of a load-bearing implant. Factors such as implant surface properties, surgical techniques, and patient-specific variables, including bone quality, influence this process.

Extensive research has aimed to enhance bone-to-implant contact (BIC), a key factor for successful osseointegration. Strategies include modifying implant surface morphology and applying bioactive agents, both intended to improve BIC and support long-term implant integration.

Many preclinical and clinical studies have documented the regeneration of horizontal gaps smaller than 2 mm in the presence of a stable blood clot but when the peri-implant gap distance was more than 2mm the bone graft should be used to seal this bony defect.

Herbal medicine has gained researchers' attention for the treatment of oral and periodontal diseases due to its beneficial, safer, integrated effects, reduced cost an minimal side effects.Nigella sativa (NS) is known as "black seed", a flower in plant that grows in Middle East, some Asian and Mediterranean countries.

Thymoquinone (TQ) is one of the main bioactive components of NS, it has valuable therapeutic effect because of its anti-oxidant, antimicrobial, analgesic, anti-inflammatory, antihypertensive, anti-histaminic, hypoglycemic, hepatoprotective, anticarcinogenic, and immune-activating properties. Considering the anti-inflammatory, antimicrobial and antioxidant characteristics of TQ, it may play a significant role in preventing the initiation, progression and treatment of periodontal diseases.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

All participants, investigators, surgeons, and outcomes investigator are masked

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1- Patients ages more than 18 years old, Participants were chosen according to specific eligibility criteria, requiring them to be healthy individuals classified as ASA I by the American Society of Anesthesiologists.
  • 2- Patients requiring extraction of posterior teeth with consequent immediate implant placement.
  • 3- Indications for extraction included: non restorable teeth (posterior teeth), untreatable caries, endodontic failures, remaining roots, vertical fracture of the roots.
  • 4- Natural teeth adjacent to the tooth to be extracted will required to have complete occlusal surfaces and be free from infections..
  • 5. Patients will selected with a thick soft tissue phenotype and a minimum keratinized tissue width (KTW) of 2 mm.

排除标准

  • Pathologies or drugs that alter tissue integration with dental implants. 2- Head and neck radiation therapy. 3- Renal disease, bleeding disorders and anticoagulant therapy. 4- Pregnant females. 5- Patients with severe para-functional habits and unfavorable occlusion 6- Smokers. 7- Malaligned teeth and teeth with acute periapical pathosis.

研究组 & 干预措施

surgical implants will inserted immediately after teeth extraction with xenograft.

Placebo Comparator

immediat implant placement with bone graft hydrogel

干预措施: group 1 xenograft hydrogel (Procedure)

study group

Active Comparator

surgical placement of 22 implants will inserted immediately after teeth extraction, combined xenograft and TQ gel.

干预措施: immediat implant placement wit TQ and bone graft hydrogel placement around implant (Procedure)

结局指标

主要结局

primary stability

时间窗: 0, 3 months

Evaluate the primary stability by osstell pre- and post-3-month during abutment placement, this meaure from 1-99 ISQ

次要结局

  • secondary outcomes(baseline, 3 months, and 6 months)
  • secondary outcome(3 months and 6 months)

研究者

发起方
shaimaa hamdy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

shaimaa hamdy

lecturer of periodontology

Minia University

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