Clinical Application of Er:YAG Dental Laser System

Not Applicable

Completed

• Conditions: Laser Therapy

• Registration Number: NCT04811144
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

The study aim was to evaluate the effectiveness of Er:YAG dental laser treatment modality for cavity, sensitive teeth, abnormal frenum attachment and peri-implantitis.

Detailed Description

There are four indications will be included in this plan. They are Cavity, Sensitive Teeth, Abnormal Frenum Attachment and Peri-implantitis. Each indication has different procedures which are listed as below:

Cavity: history records, affected range check, X-ray\&photo, treatment, pain index check, return visit check after two weeks. Sensitive Teeth: history records, sensitive check, X-ray\&photo, treatment, pain index and effectiveness check, return visit check after two weeks. Abnormal Frenum Attachment: history records, abnormal position check, photo, cutting, pain index check, return visit check after three, five and seven days. Peri-implantitis: History records, measure periodontal pocket depth, anaerobes collect, X-ray, photo, CT, treatment, pain index check, return visit check after one week, two weeks, four weeks and three months, six months check the effectiveness and collect anaerobes during every return visit. In the last return visit, X-ray and CT would be included.

Study Timeline

• Study Start: 2017-12-08
• Primary Completion: 2019-10-29
• Study Completion: 2019-10-29
• Status Verified: 2021-03
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Last Update Submitted: 2021-03-22
• Study First Posted: 2021-03-23
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Ages: 20 years and above。
• Patients are available for multiple follow-up visits for the duration of the study.
• Having the mental ability to express informed consent.
• Patients clinically diagnosed as having Cavity, Sensitive Teeth, Abnormal Frenum Attachment or Peri-implantitis.

Exclusion Criteria

• Severe diabetes and chronic diseases are excluded.
• CVA patients or the patients taking anti-rejection medicine and osteoporosis drugs for long-term should be excluded.
• Patient who suffer from photodermatosis and photosensitive patients (photoallergic).
• The health condition is not well after health education and physical therapy are excluded.
• Surgery on patients with serious diseases of the hemopoietic system (such as haemophilia and leukaemia).
• Malignant tumours, obligate precancerous tumours, hemangiomas.
• Coronary heart disease and chronic obstructive pulmonary diseases are excluded.
• Pregnant woman.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pain index	two weeks	The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) and can be used for adults and children 10 years old or older
sensitive check	two weeks	The dentist asked participants few questions about dental status. Do you feel sudden discomfort in your teeth when you drink hot or cold beverages you once considered normal?
Abnormal Frenum Attachment	a week	wound healing status
Probing depth	six months	dentist measurement participant's probing depth the distance from the gingival margin to pocket base

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan