跳至主要内容
临床试验/NCT06858033
NCT06858033已完成不适用

Assessment of the Effect of Labio-Lingual Spring Hawley and Clear Aligners on Children's Oral Microflora and Salivary Parameters

Ozge Gungor2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
PIaque index (PI)

研究概览

简要总结

Objective: The aim of our study was to determine the effect of two different types of removable appliances on periodontal health, dental plaque colonization, as well as saliva, pH, flow rate, and buffering capacity of the patients.

Method: A total of 30 pediatric patients aged 7-12 years were treated with a total of 30 appliances including 15 clear aligners (Group A) and 15 labiolingual spring hawleys (Group B). In the clinical examination of the patients, dental caries status was evaluated by DMFT and dft index, periodontal health status was evaluated by probing pocket depth measurements and plaque, gingival and probing bleeding indices. In addition, saliva and dental plaque samples were taken and salivary parameters and microbiologic structure of plaque were analyzed. All these procedures were performed in 2 different time periods for each patient; before and after the treatment. The results were statistically evaluated using SPSS (SPSS Statistics v23.0 for Windows, Chicago, IL, USA).

详细描述

In the clinical examination of the participants, dental caries status was evaluated by DMFT and dft index, and periodontal health status was evaluated by probing pocket depth measurements; PI, GI, SDI. In addition, saliva and dental plaque samples were taken and salivary parameters (flow rate, pH and buffering capacity) and microbiological structure of plaque were analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Dental anterior crossbite

排除标准

  • Skeletal anterior crossbite
  • Systemic disease
  • Regular medication use

结局指标

主要结局

PIaque index (PI)

时间窗: 3 months

Based on Silness-Löe (1963, 1967) PI values, bacterial plaque and plaque thickness in direct contact with the marginal gingiva are evaluated. The evaluation is made with the Williams-marked University of Michigan 'O' periodontal probe, and PI values are recorded from a total of 4 surfaces of each tooth included in the study, namely mesial, distal, buccal and lingual. The averages of these values are calculated for each patient. The average scores obtained are evaluated in the 0-3 score range. An increase in the calculated scores indicates that periodontal health is negatively affected.

DMFT index

时间窗: 3 months

To determine the DMFT index score, decayed teeth in permanent teeth are indicated as "D", lost teeth extracted due to decay are indicated as "M", and filled teeth are indicated as "F". The DMFT index is calculated by adding the D, M, F values and dividing them by the total number of permanent teeth. An increase in the calculated scores indicates that oral and dental health is negatively affected.

Oral microorganisms count

时间窗: 3 months

S. mitis, S. salivarius, S.mutans, C. albicans (cfu/ml)

Gingival index (GI)

时间窗: 3 months

The degree of gingivitis is assessed using the Silness-Löe (1963, 1967) GI. The average of the measurements taken from four sides of the tooth determines the GI score of the tooth, and the average of the measurements of all teeth determines the individual's gingival index score. The scores obtained are evaluated in the range of 0-3. An increase in the calculated scores indicates that periodontal health is negatively affected.

Bleeding on probing index (BOP)

时间窗: 3 months

In order to determine the inflammatory status of the pocket base and pocket epithelium, a score is given as positive (+) or negative (-) according to whether there is bleeding in the sulcus 20 seconds after the pocket depth measurement from a total of 4 surfaces of the teeth, mesial, distal, buccal and lingual. BOP is calculated as a score by dividing the number of bleeding teeth by the total number of tooth surfaces in each patient. An increase in the calculated scores indicates that periodontal health is negatively affected.

dft index

时间窗: 3 months

The dft Index is the calculated form of the DMFT index for primary teeth. When calculating the dft group index, missing teeth are not included in the calculation. Because it is difficult to diagnose the reason for the loss of primary teeth and there is a high probability of error. For this reason, the number of decayed and filled teeth is calculated during the examination. Decayed teeth are indicated with "d" and filled teeth with "f". The dft index is calculated by adding the d and f values and dividing them by the total number of permanent teeth. An increase in the calculated scores indicates that oral and dental health is negatively affected.

次要结局

未报告次要终点

研究者

发起方
Ozge Gungor
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ozge Gungor

pHd, DDS, Assoc. Prof. Dr. Pediatric Dentist

Akdeniz University

研究点 (2)

Loading locations...

相似试验