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Clinical Application of Er:YAG Dental Laser System

22 mars 2021 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

129

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: 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
Experimentell: 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.
Enhet: 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
Experimentell: 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.
Enhet: 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
Experimentell: 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
Enhet: 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
Inget ingripande: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
pain index
Tidsram: 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
Tidsram: 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
Tidsram: a week
wound healing status
a week
Probing depth
Tidsram: six months
dentist measurement participant's probing depth the distance from the gingival margin to pocket base
six months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 december 2017

Primärt slutförande (Faktisk)

29 oktober 2019

Avslutad studie (Faktisk)

29 oktober 2019

Studieregistreringsdatum

Först inskickad

22 mars 2021

Först inskickad som uppfyllde QC-kriterierna

22 mars 2021

Första postat (Faktisk)

23 mars 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 mars 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 mars 2021

Senast verifierad

1 mars 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • KMUHIRB-F(II)-20170083

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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