Clinical Application of Er:YAG Dental Laser System

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04811144
Collaborator
(none)
129
1
5
22.7
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Er:YAG dental laser
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
129 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Application of Er:YAG Dental Laser System
Actual Study Start Date :
Dec 8, 2017
Actual Primary Completion Date :
Oct 29, 2019
Actual Study Completion Date :
Oct 29, 2019

Arms and Interventions

Arm Intervention/Treatment
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
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

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
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

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
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

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
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

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

Outcome Measures

Primary Outcome Measures

  1. pain index [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 [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 [a week]

    wound healing status

  4. Probing depth [six months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807

Sponsors and Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04811144
Other Study ID Numbers:
  • KMUHIRB-F(II)-20170083
First Posted:
Mar 23, 2021
Last Update Posted:
Mar 23, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Results

No Results Posted as of Mar 23, 2021