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Completed

NCT Number: NCT04811144

Clinical Application of Er:YAG Dental Laser System

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.

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Key information

Conditions

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. pain index

    Time frame: 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

  2. sensitive check

    Time frame: 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?

  3. Abnormal Frenum Attachment

    Time frame: a week

    wound healing status

  4. Probing depth

    Time frame: six months

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

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 23, 2021
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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