Clinical Application of Er:YAG Dental Laser System

Kaohsiung Medical University

Status: Completed

Conditions: Laser Therapy

Treatments: Device: Er:YAG dental laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04811144

KMUHIRB-F(II)-20170083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 5 patient groups

Cavity group

Experimental group

Description:

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.

Treatment:

Device: Er:YAG dental laser

Sensitive Teeth group

Experimental group

Description:

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.

Treatment:

Device: Er:YAG dental laser

Abnormal Frenum Attachment group

Experimental group

Description:

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.

Treatment:

Device: Er:YAG dental laser

Peri-implantitis intervention group

Experimental group

Description:

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

Treatment:

Device: Er:YAG dental laser

Peri-implantitis control group

No Intervention group

Description:

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