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临床试验/NCT05424458
NCT05424458已完成不适用

Changes of Dental Anxiety, Aesthetic Perception and Oral Health-related Quality of Life Related to Influencing Factors of Patients' Demographics After Anterior Implant Treatment

Feilong Deng1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
1
主要终点
Changes of the Oral Health Impact Profile (OHIP) before and after anterior implant treatment

研究概览

简要总结

Accumulating evidence has revealed the effects of anterior implant procedures on dental anxiety (DA), aesthetic perception and oral health-related quality of life (OHRQoL). However, few reported the changes and influencing factors of the above outcomes before and after anterior implant treatment. The aim of this study was to evaluate the changes of DA, aesthetic perception and OHRQoL related to influencing factors of patients' demographics after anterior implant treatment.

详细描述

The purpose of this prospective study was to evaluate the changes of DA, aesthetic perception and OHRQoL related to influencing factors of patients' age, gender and educational status after anterior implant treatment.

The subjects (n=39) included in this prospective study were recruited from those patients with anterior missing teeth at the Department of Oral Implantology, Guanghua School of Stomatology, Sun Yat-sen University.

Patients satisfying the following inclusion criteria were recruited: (1) age≥18 years old; (2) partially anterior edentulous jaws; (3) patients will be given an anterior implant surgery and implant-supported fixed rehabilitation; (4) patients could express themselves and communicate normally; (4) willing to participate in and accept investigation. Exclusion criteria were (1) use of anti-anxiety and painkillers within 1 year.; (2) mental and psychological diseases with poor emotional self-control; (3) a history of previous implant loss; (4) ongoing active infections by endodontic or periodontal problems of all the remaining teeth; (5) combined complex surgery including maxillary sinus augumentation, and large-block autogenous bone grafting.

Before implant surgery, all participants signed an informed consent form and were given sufficient time in the waiting room to answer the following three scales. The modified dental anxiety scale (MDAS) included five questions with a 5-category scale, ranging from 'not' to 'extremely'. The Orofacial Esthetics Scale (OES) is a scale that was designed by 8 items to evaluate the self-perception of aesthetic implant treatment (Ranged from 0 to 10 scores, 0 is 'Very dissatisfied' and 10 is 'Very satisfied'). The Oral Health Impact Profile (OHIP) is to measure OHRQoL, comprising 14 statements with 5 scores (1 = Not, 2 = Seldom, 3 = Sometimes, 4 = Often, 5 = Very often; total scores: 14-70). Influencing factors of patients' demographics including age, gender and educational status were obtained from the medical records.

Patients received routine examinations before surgery. The surgical procedures were performed by experienced experts. Immediate loading protocol was delivered if the insertion torque was over 35 N·cm; otherwise, removable restorations with submerged implants were applied. After a healing period of 3 to 6 months, a definitive screw-retained porcelain-fused-to-metal (PFM) or a CAD/CAM zirconia restoration were performed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Supportive Care
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

  • age≥18 years old
  • partially anterior edentulous jaws
  • patients will be given an anterior implant surgery and implant-supported fixed rehabilitation
  • patients could express themselves and communicate normally
  • willing to participate in and accept investigation

排除标准

  • use of anti-anxiety and painkillers within 1 year
  • mental and psychological diseases with poor emotional self-control
  • a history of previous implant loss
  • ongoing active infections by endodontic or periodontal problems of all the remaining teeth
  • combined complex surgery including maxillary sinus augumentation, and large-block autogenous bone grafting

结局指标

主要结局

Changes of the Oral Health Impact Profile (OHIP) before and after anterior implant treatment

时间窗: Before implant surgery and in the first month after definitive prosthesis placement

Oral health-related quality of life changes between two time points. The Oral Health Impact Profile (OHIP) is to measure OHRQoL, comprising 14 statements with 5 scores (1 = Not, 2 = Seldom, 3 = Sometimes, 4 = Often, 5 = Very often; total scores: 14-70).

Changes of the Orofacial Esthetics Scale (OES) before and after anterior implant treatment

时间窗: Before implant surgery and in the first month after definitive prosthesis placement

Aesthetic perception changes changes between two time points. The Orofacial Esthetics Scale (OES) is a scale that was designed by 8 items to evaluate the self-perception of aesthetic implant treatment (Ranged from 0 to 10 scores, 0 is 'Very dissatisfied' and 10 is 'Very satisfied').

Changes of the modified dental anxiety scale (MDAS) before and after anterior implant treatment

时间窗: Before implant surgery and in the first month after definitive prosthesis placement

Dental anxiety levels changes between two time points. The modified dental anxiety scale (MDAS) included five questions with a 5-category scale, ranging from 'not' to 'extremely'. On MDAS questionnaire numbers correspond to the dimensions (1 = Not, 2 = Slightly, 3 = Fairly, 4 = Very, 5 = Extremely. Overall MDAS score: Q1-Q5 summary score.).

次要结局

未报告次要终点

研究者

发起方
Feilong Deng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Feilong Deng

Professor

Hospital of Stomatology, Sun Yat-Sen University

研究点 (1)

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