Clinical Application of Er:YAG Dental Laser System
22. marts 2021 opdateret af: Kaohsiung Medical University Chung-Ho Memorial Hospital
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
129
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Kaohsiung, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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
|
|
Eksperimentel: 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.
|
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
|
|
Eksperimentel: 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.
|
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
|
|
Eksperimentel: 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
|
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
|
|
Ingen indgriben: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
pain index
Tidsramme: 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
|
two weeks
|
|
sensitive check
Tidsramme: 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?
|
two weeks
|
|
Abnormal Frenum Attachment
Tidsramme: a week
|
wound healing status
|
a week
|
|
Probing depth
Tidsramme: six months
|
dentist measurement participant's probing depth the distance from the gingival margin to pocket base
|
six months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. december 2017
Primær færdiggørelse (Faktiske)
29. oktober 2019
Studieafslutning (Faktiske)
29. oktober 2019
Datoer for studieregistrering
Først indsendt
22. marts 2021
Først indsendt, der opfyldte QC-kriterier
22. marts 2021
Først opslået (Faktiske)
23. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .