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临床试验/NCT04864197
NCT04864197Unknown3 期

Assessment of Keratinized Gingiva With and Without PRF Application in Patients With Dental Implant

University of Baghdad2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年12月19日最近更新:
适应症

试验速览

阶段
3 期
入组人数
10
试验地点
2
主要终点
measuring gingival thickness

研究概览

简要总结

we used prf with dental implant treatment to find out whether prf has an effect on increasing the soft tissue thickness and keratinized tissue width

详细描述

Clinical oral implant related research is facing many interesting challenges. One of them is to create and maintain stable soft and hard tissues around osseointegrated oral implants.

It was suggested in a classic study that a minimum of 2 mm of keratinized mucosa (KM) around natural teeth is necessary to maintain gingival health. The lack of a sufficient wide zone of KM has been investigated as a potential contributing factor for peri- implant disease and therefore might influence the long- term success of oral implants.

Various studies have found a negative influence of the absence of KM on plaque accumulation. Oral implants with a narrow zone of KM (<2 mm) frequently exhibit significantly higher plaque scores than those with wider zones of KM. Even a subdivision can be made between KM and attached KM (AKM). A statistically significant higher plaque accumulation and gingival inflammation around implants in the groups with KM <2 mm and AKM <1 mm was observed. However, this could not be confirmed in another study.

Interestingly, the presence of an adequate band of KM adjacent to the implant seems to reduce inflammation, hyperplasia and recession of the marginal peri- implant soft tissues. Furthermore, it might facilitate restorative procedures, improve aesthetics and enable the patient to maintain an adequate oral hygiene without irritation or discomfort.

In particular, in the lower jaw, a scarce amount of KM can be regularly encountered. A reduced height of the alveolar process, due to crestal bone resorption, result in loss of KM due to the reduced distance between the bone crest and "genetically defined" position of the mucogingival line. Notably, in the posterior segments of the lower jaw, a narrow KM might be related to muscle pull, high frenulum attachments and a shallow vestibule.

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
Double (Participant, Investigator)

盲法说明

Third professional person apply PRF membrane.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients greater than 18 years old without systemic diseases and having good oral hygiene (with D1-D3 bone density).

排除标准

  • general contraindications to implant surgery.
  • patients with a history of severe periodontitis.
  • bone augmentation required.
  • treated or under treatment with intravenous aminobisphosphonates.
  • pregnant or lactating.

结局指标

主要结局

measuring gingival thickness

时间窗: 6 months

transgingival measurement my endodontic reamer and then using digital vernier to determine the thickness

次要结局

  • keratinized tissue width(6 months)

研究者

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

Hussain Falah Mohsen

dentist (MSc student)

University of Baghdad

研究点 (2)

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