Clinical Application of Er:YAG Dental Laser System

Laser Therapy Clinical Trial

Official title:

Clinical Application of Er:YAG Dental Laser System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811144
• Other study ID #: KMUHIRB-F(II)-20170083
• Status: Completed
• Phase: N/A
• Start date: December 8, 2017
• Est. completion date: October 29, 2019

Study information

• Verified date: March 2021
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laser Therapy

Intervention

Device:
• Er:YAG dental laser
To treat Cavity, Sensitive Teeth, Abnormal Frenum Attachment and Peri-implantitis by using Er:YAG Dental Laser system which manufactured by LightMed Dental Technology Corp

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain index	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	two weeks
Primary	sensitive check	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?	two weeks
Primary	Abnormal Frenum Attachment	wound healing status	a week
Primary	Probing depth	dentist measurement participant's probing depth the distance from the gingival margin to pocket base	six months