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临床试验/NCT07088809
NCT07088809Enrolling By Invitation不适用

Comparative Study Between Hydroxyapetite Nanoparticles and Tricalcium Phosphate Nanoparticles Loaded on Platelet Rich Fibrin Membranes for Treatment of Gingival Recession

Enas Elgendy1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
20
试验地点
1
主要终点
Height of the keratinized tissue (HKT)

研究概览

简要总结

The "Glossary of the American of Periodontology" defines gingival recession (GR) as the apical movement of the gingival margin beyond the cement-enamel junction. Therefore, root surface exposure brought on by gingival recession results in cosmetic impairment, fear of tooth loss, increased susceptibility to root caries, and dentin hypersensitivity. The use of free gingival grafts, sliding pedicle grafts, subepithelial connective tissue grafts, envelope or tunnelling techniques, the use of acellular dermal, connective tissue allografts, guided tissue regeneration, and coronally advanced flap (CAF) are the surgical methods that have been developed to treat gingival recession. The medical area has been invaded by nanotechnology, and the findings are highly promising. Nanomaterials perform far better than conventional materials thanks to their superior surface, size, and quantum effects. Hydroxyapatites (HAs) are a family of materials used for bone grafting that have a high level of biocompatibility, which is partly due to their inclusion in naturally calcified tissue. The aim of the present study was to compare between nanocrystalline hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival recession in human.

详细描述

The primary objective of periodontal therapy is the regeneration of periodontal tissues that have been lost owing to periodontal disease since gingival recession results in the loss of both soft and hard tissue. Periodontal regeneration, demonstrated histologically by the development of new cementum, new alveolar bone, functionally orientated periodontal ligament, and gingiva, is the rebuilding of the lost tissues. Platelet rich fibrin (PRF), which contains significant amounts of growth factors, platelets, fibrin membrane, leukocytes, and cytokines, was introduced for periodontal regeneration. The capacity of PRF to boost collagen production and fibroblast proliferation has been demonstrated, and it is widely used to repair and enhance the regeneration of both soft tissues and hard tissues following various periodontal surgical procedures. Xenografts were established in the field of periodontology to address the drawbacks of autogenous bone graft and allograft. Although these materials provide a solution to some of the aforementioned issues, the issue of immunogenicity and the transmission of disease had been frequently brought up; as a result, alloplastic materials were produced. These substances, which are artificial, inorganic, and biocompatible bone graft alternatives, offer a potential substitute for the treatment of periodontal disorders. The benefits of these materials include better accessibility, the removal of the requirement for a donor site, and the absence of any risk of disease transmission. In controlled clinical studies, hydroxyapatite (HA) and tricalcium phosphate (TCP), two alloplastic materials, significantly improved clinical outcomes at grafted locations compared to non-grafted sites. Cone beam computed tomography produces 3D images that are required in periodontics for the diagnosis of intra bony defects, furcation involvements, and destructions of the buccal and lingual bones. The objective of this study was to compare the effectiveness of nanocrystalline hydroxyapatite and tricalcium phosphate, both applied on a PRP membrane, in treating Miller's class 1 gingival recession in humans.

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
Single (Participant)

入排标准

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

入选标准

  • •Patients with good systemic health and no contraindication for periodontal surgery.
  • •Patients who are able to maintain good oral hygiene.
  • •Gingival thickness for the site selected should be ≥1mm.
  • •The height of keratinized gingiva (HKG) for the site selected should be ≥1 mm (HKG is the distance between the most apical point of the gingival margin and the mucogingival junction).

排除标准

  • •Active infectious diseases (hepatitis, tuberculosis, HIV, etc....).
  • •Medically compromised patients.
  • •Patients taking medications known to cause gingival enlargement.
  • •Pregnant patients and smokers.
  • •Previous mucogingival surgery at the defect.
  • •Restorations or caries in the area to be treated and non vital tooth.
  • •Teeth which are tilted or rotated.

研究组 & 干预措施

Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap

Experimental

Ten sites with gingival recession treated with Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap.

干预措施: Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap (Procedure)

Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap

Experimental

Ten sites of gingival recession treated with Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap

干预措施: Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap (Procedure)

结局指标

主要结局

Height of the keratinized tissue (HKT)

时间窗: 1, 3 and 6 month post surgically

Height of the keratinized tissue (HKT): distance between the most apical point of the GM and the mucogingival junction (MGJ).

Percentage of root coverage (RC)

时间窗: after 1, 3, 6 months post operatively

Percentage of root coverage (RC): is calculated after 1, 3, 6 months as \[RH preoperative - RH postoperative\]/RH preoperative) x 100%.

Facial bone level

时间窗: 6 months

Facial bone level was the distance from the apex of the tooth to most coronal point of the facial bone.

Horizontal facial bone thickness

时间窗: after 6 months

Horizontal facial bone thickness was the thickness of the facial bone at the middle of the root length.

Recession height (RH)

时间窗: at 1, 3 and 6 month post surgically

distance between cemento-enamel junction (CEJ) to the most apical point of the gingival margin (GM).

Recession width (RW)

时间窗: at 1, 3 and 6 month post surgically

from one border of the recession to another, measured at the CEJ.

次要结局

  • Gingival index (GI)(at 1, 3 and 6 month post surgically)
  • Probing pocket depth (PPD)(at 6 months post surgically)
  • Clinical attachment level (CAL)(at 6 months post surgically)
  • Wound healing index (WHI)(at 14 days and 1, 3, and 6 months after surgery.)
  • Bone density(after 6 months)
  • Plaque index(at 1, 3 and 6 month post surgically)

研究者

发起方
Enas Elgendy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Enas Elgendy

Prof of Oral Medicine and Periodontology

Kafrelsheikh University

研究点 (1)

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