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CompletedNCT04811144Updated Mar 23, 2021

Clinical Application of Er:YAG Dental Laser System

An interventional study of Er:YAG dental laser in Laser Therapy, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-23.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Dec 2017, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Laser Therapy

Keywords

  • Er:YAG
  • dentistry
03

In context

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
129 participants (actual)

Study arms

  • Experimental
    Cavity group

    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

  • Experimental
    Sensitive Teeth group

    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

  • Experimental
    Abnormal Frenum Attachment group

    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

  • Experimental
    Peri-implantitis intervention group

    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

  • No intervention
    Peri-implantitis control group

    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

  • DeviceEr: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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: two weeks

  2. 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?

    Time frame: two weeks

  3. Abnormal Frenum Attachment

    wound healing status

    Time frame: a week

  4. Probing depth

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

    Time frame: six months

07

Study locations

1 site
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung, 807, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04811144
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Mar 23, 2021
Start date
Dec 8, 2017
Primary completion
Oct 29, 2019
Completion
Oct 29, 2019
Last update
Mar 23, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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