跳至主要内容
临床试验/NCT07492576
NCT07492576招募中不适用

Evaluation of the Magnesium Shield Compared to Dual Zone Grafting Approach in Immediate Implant Site Management: a Randomized Controlled Clinical Trial

British University In Egypt1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2026年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
22
试验地点
1
主要终点
bucco-palatal dimensional ridge changes

研究概览

简要总结

Will (GBR) by application of magnesium membrane with immediate implant will have more volume gain , higher pink esthetic score, and lower visual analogue scale than dual zone grafting technique? Several methods have been suggested for the preservation of post-extraction resorption and promoting an increase in the bone density with immediate implant placement. one of these techniques is the dual zone concept (DZ), atraumatic tooth extraction using peristomes and luxators, implant placement along with the bone grafting material applied to both the bone and tissue zones.

The aim of (DZ) is to augment the soft tissue using a bone graft to avoid mucosal recession after implant placement thus keeping the gingival contour providing optimal soft tissue aesthetic.

The use of magnesium membrane in combination with inorganic bovine bones will be placed between the membrane and immediate implant. This allows implant placement while simultaneously rehabilitating the entire socket, due to its unique material properties, a magnesium membrane is used to rebuild, support the buccal or oral walls in compromised sockets, and promotes cortical bone growth . Many techniques available for preserving the bone of the socket post-tooth extraction, but in comparison to the current materials and techniques used , magnesium membrane is completely resorbable and does not require second surgery to be removed; it is synthetic and therefore does not need to be sourced from an additional surgical. magnesium membrane is excellent in providing both esthetic and functional outcomes that meet patient expectations.

The procedure involves flapless approach in which atraumatic tooth extraction using peristomes and forceps will be performed to preserve the available alveolar bone. The implant site will be prepared, and the implant will be placed palatal and 3-4m.m apical to the free gingival margin (FGM). magnesium membrane will be placed between the soft tissue and thin buccal wall. The edges of the membrane will be shaped and flattened with sculptor to prevent perforation of the soft tissue, and a layer off inorganic bovine bone will be placed between the e buccal wall and implant. Then immediate provisional restoration will be constructed and placed to allow an ideal final crown mimicking the natural emergence profile.

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 (Outcomes Assessor)

盲法说明

The biostatistician will be blinded

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-60 years of age
  • Patients have hopeless maxillary teeth, a thin buccal plate of bone ≤1 mm and intact overlying soft tissue intact overlying soft tissues in aesthetic zone (EDS-2, Kan classification)
  • Periodontally healthy (good oral hygiene)
  • Medically controlled patient

排除标准

  • patients with systemic diseases
  • history of chemotherapy or radiotherapy within the past 2 years.
  • Acute infection

结局指标

主要结局

bucco-palatal dimensional ridge changes

时间窗: Pre-operative , day 1 , then 3,6 , 9 months later

The Bucco-palatal dimensional ridge alterations were assessed via digital scans to assess the difference and changes in the overall ridge dimensions (mm). Reference points were assigned in the baseline measurements of the scans using the Standard Triangle Language (STL) files of the models obtained via digital scanning to allow standardized comparisons after 3,6, and 9 months. The 3D software allowed the alignment of the reference points identified on the models.

次要结局

  • Pink esthetic score (PES)(Baseline, 3 , 6,and 9 months)
  • • Volumetric changes ( digital scanner )(Pre-operative ,day 1 , 3,6 ,and 9 months)
  • • Mid facial mucosal recession (MFR)(Pre-operative baseline and 3,6,9 months)
  • • Labial bone thickness(The labial bone thickness will be measured at day 1and 9 months later)
  • • Soft tissue thickness (STT)(measured at baseline and 9 months)
  • Visual analogue scale measures postoperative pain (VAS)(3 days , 7 days ,and 14 days)
  • • Probing depth(Baseline and 9 months)
  • • Plaque index(Baseline and 9 months)
  • • Bleeding index(Baseline and 9 months)

研究者

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

RIM MAZEN

Rim Mazen Ghanem , demonstrator , faculty of dentistry, the British university in Egypt

British University In Egypt

研究点 (1)

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