跳至主要内容
临床试验/NCT07091890
NCT07091890进行中(未招募)不适用

Microbiology and Clinical Efficacy of Professional Topical Fluoride on Streptococcus Mutans and Selemonas Sputigena in Orthodontic Patients: a Randomized Clinical Trial

Universita di Verona1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Quantitative evaluation of Streptococcus mutans

研究概览

简要总结

This study was born from the need to improve caries prevention in orthodontic patients, a group particularly at risk. Fixed orthodontic appliances make daily oral hygiene more difficult, leading to increased plaque accumulation and the proliferation of cariogenic bacteria such as Streptococcus mutans and, more recently, Selenomonas sputigena. Although the latter does not cause cavities on its own, it enhances the action of Streptococcus mutans, making the caries process more aggressive.

The aim of the research was to evaluate the effectiveness of two different types of professional topical fluoride-gel and varnish-in reducing the presence of these bacteria and improving certain clinical parameters, such as salivary pH, the DMFT index (which measures decayed, missing, and filled teeth), and the Plaque Control Record (PCR%).

The study involved 45 patients, all between 8 and 17 years old and wearing fixed orthodontic appliances. They were divided into three groups: one received fluoride gel, another received fluoride varnish, and the third group underwent only a professional oral hygiene session, without any fluoride application. All patients were evaluated at the beginning of the study (T0) and again after four months (T1), both clinically and microbiologically, through saliva and plaque analysis.

The results showed that in the fluoride-treated groups-especially the varnish group-there was a significant reduction in plaque, an improvement in salivary pH (mainly in the gel group), and a decrease in the presence of S. mutans and S. sputigena. Furthermore, there was a reduction in oral Streptococci and Lactobacilli levels in the treated groups, whereas these levels increased in the control group. Interestingly, although not all differences were statistically significant, the improvements observed in the treatment groups suggest a clinically relevant benefit of topical fluoride, especially in varnish form.

In conclusion, professional application of fluoride-whether in gel or varnish form-proved effective in counteracting key bacteria responsible for dental caries in orthodontic patients and in improving several relevant clinical parameters. This confirms the importance of combining professional oral hygiene with specific fluoride treatments in patients wearing orthodontic appliances.

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 (Investigator)

入排标准

年龄范围
6 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •1 < DMFT < n-1 (n= number of teeth present in the oral cavity)
  • •age between 8 and 17 years
  • •patient wearing fixed orthodontic appliances

排除标准

  • •DMFT = 0 *; professional topical fluoride prophylaxis session carried out in the last 3 months
  • •patient not wearing fixed orthodontic appliances
  • •orthodontic treatment already completed or not started * DMFT refers to a caries prevalence index related to the presence of Decayed, Missing, Filled Teeth due to caries (Decayed, Missing, Filled Teeth).

研究组 & 干预措施

Professional oral hygiene session and a topical fluoride prophylaxis treatment with gel

Experimental

干预措施: Fluoride gel (Device)

Professional oral hygiene session and a topical fluoride prophylaxis treatment with varnish

Experimental

干预措施: Fluoride varnish (Device)

Professional oral hygiene session alone

No Intervention

All patients underwent a professional oral hygiene session to remove bacterial plaque and calculus from the tooth surfaces. Bacterial plaque was removed using a supragingival air-polishing device that dispersed glycine powder. When calcified residues were present, a piezoelectric ultrasonic scaler with either a supragingival insert, perio-slim periodontal insert, or scaler was selectively used in cases of deposits in areas that were difficult to access

结局指标

主要结局

Quantitative evaluation of Streptococcus mutans

时间窗: T0 baseline, T1 4 months

Molecular methods Polymerase Chain Reaction - Quantitative Polymerase Chain Reaction (PCR-qPCR)

Quantitative evaluation of Selemonas sputigena

时间窗: T0 baseline, T1 4 months

Molecular methods Polymerase Chain Reaction - Quantitative Polymerase Chain Reaction (PCR-qPCR)

次要结局

  • Plaque Control Record(T0 baseline, T1 4 months)
  • DMFT(T0 baseline, T1 4 months)
  • Salivary ph(T0 baseline, T1 4 months)

研究者

发起方
Universita di Verona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessia Pardo

Principal Investigator

Universita di Verona

研究点 (1)

Loading locations...

相似试验