跳至主要内容
临床试验/NCT03735394
NCT03735394已完成不适用

Labial Gingival and Osseous Thickness of Upper and Lower Incisors in Thick and Thin Biotypes

Universitat Internacional de Catalunya2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
compare between maxilla and mandibular biotype measured with the periodontal probe

研究概览

简要总结

This clinical study consists on taking 2 different records of the upper and lower incisors area : 1) a perpendicular x-ray and 2) an ultrasonic measurement of gingival thickness on the labial plate. Both measurements are used in order to measure gingival and bone thickness.

The aim was to verify the reliability of the tissue measurements of an ultrasonic technique compared with the radiographic technique and to verify whether the biotype has correlation between the maxillary and mandibular biotype in the same patient.

详细描述

The examination of the patients included:

  • One color photograph of the upper and lower incisors complex with the periodontal probe introduced on the gingival sulcus
  • Gingival thickness of the most protruded upper and lower incisors was measured with the biometric scanner PIROP. A lip expander was placed and clorhexidine gel was applied on top of the ultrasonic head for better wave conduction. Measurements were taken 10 times at the same point and a mean measurement was obtained.
  • A tangential radiograph was taken on each patient perpendicular to the axis of the crown of the central upper and lower incisors with a periapical film holding system, and a metal strip (5mm x 1mm x 0,1mm) placed labial to the keratinized gingiva following the inclination of the incisor. A lip expander was used to keep the lips from touching the metal strip. Air was blown over the attached gingiva before placing the metal strip. The metal strip was placed along the long axis of the most protruded lower incisor crown.

All patients were evaluated and categorized in one of three possible categories: A1 (7 patients, 23,3%), A2 (12 patients, 40%), and B (11 patients, 36,7%). The patients were assigned into each category by two examiners, according to the visual and clinical aspect of the keratinized gingiva in the lower incisors. Group A1 and A2 both had thin keratinized gingiva and differed in width (group A1 comprised values ≤2mm, and group A2 had width values >2mm of keratinized gingiva). Group B comprised thick and wide keratinized gingiva. Width of gingiva was measured with a periodontal probe. Thickness of gingiva was assessed by probe transparency, where the examiner determined whether the periodontal probe was visible through the marginal soft tissue.

Radiographic measurements

Radiographs were scanned at a 1:1 scale. Scanned images were saved in JPEG format. Millimetric measurements were made using the Adobe Photoshop program to a 0.1mm precision. Four measurements were taken on each radiograph:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • aged 18 years or older,
  • presence of all lower incisors
  • good periodontal health without bone loss or gingival inflammation
  • no dental compensations of skeletal malocclusion
  • crowding of less than 4mm
  • no history of dental or traumatic lesions in lower incisors

排除标准

  • gingival inflammation
  • daily smokers
  • patients taking drugs that causes gingival inflammation

结局指标

主要结局

compare between maxilla and mandibular biotype measured with the periodontal probe

时间窗: 1 day

Classify all patients into one of the three established categories (A1, A2, B) with the aid of a periodontal probe, and compare within the same patient if the biotype of maxilla and mandible is the same or it differs

次要结局

  • Differences in tissue thickness according to gender(1 day)
  • thickness biotype differences(1 day)

研究者

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

Juan Rossell

assitant professor. Doctor in medical science

Universitat Internacional de Catalunya

研究点 (2)

Loading locations...

相似试验