Clinical Application of Er:YAG Dental Laser System

NCT04811144 | Completed

• 1 other identifier: KMUHIRB-F(II)-20170083
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Laser Therapy

Keywords

Er:YAG; dentistry

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Abnormal Frenum Attachment

  wound healing status

  a week

• Probing depth

  dentist measurement participant's probing depth the distance from the gingival margin to pocket base

  six months

Study Arms (5)

Cavity group

EXPERIMENTAL

The 35 participants accepted Er:YAG laser treatment for dental cavity. Each participant was collected their data including history records, affected range check, X-ray\&photo, treatment, pain index check, return visit check after two weeks by researchers.

Device: Er:YAG dental laser

Sensitive Teeth group

EXPERIMENTAL

The 35 participants accepted Er:YAG laser treatment for sensitive teeth. Each participant was collected their data including history records, sensitive check, X-ray\&photo, treatment, pain index and effectiveness check, return visit check after two weeks by researchers.

Device: Er:YAG dental laser

Abnormal Frenum Attachment group

EXPERIMENTAL

The 35 participants accepted Er:YAG laser treatment for Abnormal Frenum Attachment. Each participant was collected their data including history records, abnormal position check, photo, cutting, pain index check, return visit check after three, five and seven days. by researchers.

Device: Er:YAG dental laser

Peri-implantitis intervention group

EXPERIMENTAL

The 12 participants accepted Er:YAG laser treatment for Peri-implantitis. Each participant was collected their data including 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, and six month check the effectiveness and collect anaerobes during every return visit. In the last return visit, X-ray and CT would be included

Device: Er:YAG dental laser

Peri-implantitis control group

NO INTERVENTION

The 12 participants accepted mechanical debridement for Peri-implantitis. Each participant was collected their data including 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, and six month check the effectiveness and collect anaerobes during every return visit. In the last return visit, X-ray and CT would be included

Interventions

Er:YAG dental laser DEVICE

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

Abnormal Frenum Attachment group; Cavity group; Peri-implantitis intervention group; Sensitive Teeth group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 23, 2021
• Study Start: December 8, 2017
• Primary Completion: October 29, 2019
• Study Completion: October 29, 2019
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)