跳至主要内容
临床试验/NCT07691437
NCT07691437已完成不适用

Evaluation of the Effect of Non-Surgical Periodontal Treatment on Clinical Periodontal Status With Oral Health Impact Profile (OHIP-14) in Patients With Hemophilia

Karadeniz Technical University1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2021年3月17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
146
试验地点
1
主要终点
Oral Health-Related Quality of Life (OHIP-14) Score

研究概览

简要总结

This study aimed to evaluate the effect of non-surgical periodontal treatment (NSPT) on oral health-related quality of life in patients with hemophilia using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. In addition, clinical periodontal parameters and demographic characteristics before and after NSPT were assessed and compared with systemically healthy individuals. A total of 71 patients with hemophilia (60 with Hemophilia A and 11 with Hemophilia B) and 75 healthy individuals were included in the study and grouped according to their periodontal status. Demographic data and oral health-related behavioral characteristics were evaluated. Clinical periodontal parameters and OHIP-14 scores were recorded before treatment and at the sixth week after treatment. All collected data were analyzed statistically. The study aims to determine the relationship between periodontal treatment outcomes and oral health-related quality of life in individuals with hemophilia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 64 years.
  • Diagnosis of hemophilia A or hemophilia B (hemophilia group) or systemically healthy individuals/individuals with medically controlled systemic disease (control group).
  • Presence of at least 20 natural teeth, excluding third molars and teeth with orthodontic appliances.
  • Ability to provide written informed consent.
  • Willingness and ability to comply with study procedures

排除标准

  • Presence of bleeding disorders other than hemophilia A or B.
  • Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus or uncontrolled hypertension).
  • Use of medications known to affect periodontal tissues (e.g., calcium channel blockers, anticonvulsants, or immunosuppressive agents).
  • Fewer than 20 natural teeth.
  • Inability or unwillingness to provide informed consent or comply with study procedures.

结局指标

主要结局

Oral Health-Related Quality of Life (OHIP-14) Score

时间窗: Baseline and 6 weeks after treatment

Change in Oral Health Impact Profile-14 (OHIP-14) score from baseline to 6 weeks after non-surgical periodontal treatment. Higher scores indicate poorer oral health-related quality of life.

次要结局

  • Gingival Index (GI)(Baseline and 6 weeks after treatment)
  • Plaque Index (PI)(Baseline and 6 weeks after treatment)
  • Bleeding on Probing (BOP)(Baseline and 6 weeks after treatment)
  • Probing Pocket Depth (PPD)(Baseline and 6 weeks after treatment)
  • Clinical Attachment Level (CAL)(Baseline and 6 weeks after treatment)

研究者

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

BURAK ALEMDAĞ

Assistant Professor

Karadeniz Technical University

研究点 (1)

Loading locations...

相似试验