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临床试验/NCT05695612
NCT05695612招募中不适用

EVALUATION OF TWO DIFFERENT ATTACHMENT SYSTEMS IN MANDIBULAR OVERDENTURES RETAINED WITH TWO INCLINED IMPLANTS (A RANDOMIZED CONTROLLED CLINICAL TRIAL)

Alexandria University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年3月10日最近更新:
适应症
干预措施

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
Modified Sulcus Bleeding Index (BI)

研究概览

简要总结

The aim of the study is to evaluate clinically and radiographically the Novaloc and Locator attachment systems in mandibular overdentures retained with two inclined implants.

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, Outcomes Assessor)

入排标准

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

入选标准

  • •Patients should be completely edentulous.
  • •Patients should have enough bone for the placement of implants at least 3.5 mm in diameter and 10.0 mm in length.
  • •Patients should be co-operative and have adequate dexterity for placement and removal of the implant -retained overdenture.
  • •The inter-ridge space should be sufficient to place the endosseous implants and the superstructures

排除标准

  • •Patients with any systematic disease that could complicate the surgical phase or affect osseointegration as osteoporosis and uncontrolled diabetes mellitus.
  • •Patients with active oral infections.
  • •Patients with history of radiotherapy in head and neck region.
  • •Patients with poor oral hygiene.
  • •Patients with restricted mouth openings ≤ 40mm, functional limitations, or temporo-mandibular disorders.
  • •Heavy smokers (more than 10 cigarette / day).

研究组 & 干预措施

Novaloc Attachment

Experimental

干预措施: Novaloc Attachment (Other)

Locator attachment

Active Comparator

干预措施: Locator Attachment (Other)

结局指标

主要结局

Modified Sulcus Bleeding Index (BI)

时间窗: up to 12 months

This will be measured using a graduated plastic autoclavable periodontal probe. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implant sulcus. A score of 0-3 will be assigned to each labial and palatal surface of the implant then the average for each implant will be calculated according to the following criteria: Score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant. Score 1: Isolated bleeding spots visible. Score 2: Blood forms a confluent red line on margin. Score 3: Heavy or profuse bleeding

Peri-implant Probing Depth (PD)

时间窗: up to 12 months

The distance from the gingival margin till the point of least resistance will be measured using a graduated plastic autoclavable periodontal probe. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implant sulcus. Measurements will be made at 6 sites around each implant; mesiobuccal, mid-buccal, disto-buccal, mesio-palatal, mid-palatal and disto-palatal. Probing depth of 1 mm or less will be recorded as 1 mm, and those exceeding 1 mm, but less than 2 mm, will be recorded as 2 mm, and so on. The mean for each implant will be calculated.

Modified gingival index

时间窗: up to 12 months

The peri-implant mucosal tissues will be assessed according to Lobene and Weatherford as follows: 0: Absence of inflammation, normal gingiva. 1. Mild inflammation, slight color change, little change in texture of any portion of, but not entire, marginal, or papillary gingival unit (localized). 2. Mild inflammation, slight color change, little change in texture involving the entire or papillary gingival unit (generalized).. 3. Moderate inflammation, redness, and edema. 4. Severe inflammation, marked redness, edema, ulceration, and spontaneous bleeding It will be measured at 4 sites around each implant (mesially, distally, labially/ buccaly, lingually) then, the mean record will be calculated for each implant. Indices of the two implants will be added to each other, and then divided by 2 to get the mean modified gingival index for each case.

Alveolar bone level

时间窗: up to 12 months

The level of alveolar bone around each implant will be assessed using CBCT(3D Accuitomo 170, 90 kVp, 5 mA, 30.8 s, 0.08 mm isotropic voxel size, J Morita, Kyoto, Japan) and the field of view will be the lower anterior sextant. The vertical bone change (distance from the implant platform to the first bone-to-implant contact, in mm) around each implant will be assessed at the buccal, lingual, mesial and distal aspects then the mean will be calculated.

Implant stability

时间窗: up to 12 months

Magnetic Resonance Frequency Analyser will be used to measure the implant stability quotient (ISQ). The instrument measures the resonance frequency through the transducer attached to a implant fixture and display the result ISQ value on a scale of 1 to 100 with higher values indicating higher stability. The measurements will be made three times and the mean will be calculated.

次要结局

未报告次要终点

研究者

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

haitham ahmed hassan ismail

Assistant Lecturer of Prosthodontics

Alexandria University

研究点 (1)

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