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临床试验/NCT05418452
NCT05418452Unknown3 期

Efficacy of 1% Metformin Gel Mixed With PRF in Augmenting Narrow Ridge With Split-crest Technique and Implant Installation

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2022年6月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
2
试验地点
1
主要终点
Clinical parameter to measure difference

研究概览

简要总结

This study aimed to evaluate the efficacy of 1% metformin gel mixed with PRF, in horizontal ridge augmentation with the split-crest technique, for implant placement.

详细描述

Dental rehabilitation of edentulous patients with implants has become a common practice in the last few decades. Unfortunately, local conditions of some alveolar ridges of such patients may be challenging for implant placement. One of these conditions is a relevant horizontal deficit that may render dental implants difficult or impossible.

Several solutions are presented to overcome this challenge such as different guided bone regeneration (GBR) techniques and horizontal ridge split. However, these techniques have many shortages that may be overcome by the split crest technique (SCT).

SCT is a procedure for horizontal bone augmentation. It consists of splitting the vestibular and buccal cortical bone, displacing the vestibular cortical bone both in the maxilla or mandible, and separating from the bone marrow, creating a middle gap that is usually occupied mostly by the inserted implants. In such a procedure, ultrasonic bone surgery represents an advantageous alternative technique over conventional surgery using disks and chisels. The ultrasonic device can safely cut mineralized hard tissues such as bone with minor damage. Additionally, at the bone structural level, ultrasonic bone surgery may increase trabecular density as well as bone compression.

To enhance healing the remaining unoccupied space around the implant can be filled with biomaterials such as autologous bone grafts which are considered the gold stander, but unfortunately, site morbidity, as well as, utilizing more than one surgical site may limit its application. Alternatively, other bone substitutes including xenografts, alloplastic, and non-bone graft materials such as Platelet-Rich Fibrin (PRF) have been used in peri-implants space occupation.

PRF is a blood derivative in which platelets have a higher concentration above the baseline level. it can regulate inflammation and stimulate the immune process of chemotaxis. This natural material seems to accelerate the physiological wound healing with or without bone grafts to accelerate new bone formation. (6)In clinical practice, it has already been largely applied as an inexpensive carrier and way to obtain many growth factors (GFs) in physiological proportions. Hence, enhanced bone regeneration and favorable implant healing can be better achieved by using PRF as a graft around dental implants. Some authors reported that the use of PRF as a sole filling material during a simultaneous SCT and implantation stabilized a high volume of natural regenerated bone in the spaces unoccupied by the implants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (age 18-50) exhibiting initial insufficiently bone ridge.
  • Patients with good oral hygiene.
  • Free from systemic diseases that may influence the outcome of the therapy.

排除标准

  • Heavy smokers.
  • Patient treated by immunosuppressive chemotherapy or radiotherapy,
  • Allergy to any material or medication used in the study.

研究组 & 干预措施

metformin

Experimental

will receive split-crest technique by ultrasonic bone surgery with implant placement and PRF mixed with 1% metformin gel

干预措施: Metformin (Drug)

结局指标

主要结局

Clinical parameter to measure difference

时间窗: to detect change from baseline at time (immediately after implant insertion) and after 6 months.

Implant stability (resonance frequency analysis)

次要结局

  • Radiological assessment to measure difference(to detect change from baseline (immediately after surgery), at time of loading (6 months), and 6 months after loading)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelaziz Kamal Aboamo

assistant professor at AlAzharU department of Periodontology

Al-Azhar University

研究点 (1)

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