- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07730658
Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children
Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children: A Randomized Clinical Trial
The goal of this randomized clinical trial is to compare the effect of erythritol air-polishing and conventional polishing following ultrasonic scaling on the relapse of chromogenic tooth staining in children aged 4-13 years attending the Pediatric Dentistry Clinic of Marmara University Faculty of Dentistry for routine dental examination.
The main questions this study aims to answer are:
- Does erythritol air-polishing reduce the relapse of chromogenic tooth staining compared with conventional polishing following ultrasonic scaling?
- Is there a difference in the time to relapse of chromogenic tooth staining between the two polishing techniques?
Researchers will compare conventional polishing (prophylaxis paste and a polishing brush) following ultrasonic scaling with erythritol air-polishing performed using the EMS air-polishing device following ultrasonic scaling to determine whether one method is more effective in preventing or delaying the relapse of chromogenic tooth staining.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Participants will:
Undergo a routine oral examination. Receive professional removal of chromogenic tooth staining using ultrasonic scaling.
Be randomly assigned to receive either conventional polishing with prophylaxis paste and a polishing brush or erythritol air-polishing using the EMS air-polishing device.
Attend follow-up visits to assess the recurrence of chromogenic tooth staining over time.
Chromogenic tooth staining will be assessed using the Qraycam.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
MALTEPE
-
Istanbul, MALTEPE, Tyrkia (Türkiye), 34854
- Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi
-
Ta kontakt med:
- Betul Sen Yavuz
- Telefonnummer: +90 539 988 76 46
- E-post: dtbetulsen@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Children aged 4-13 years.
- Absence of oral diseases, including gingivitis and oral mucosal diseases.
- No orthodontic appliances.
- No history of iron supplementation or professional fluoride treatment within the previous 3 months.
- Systemically healthy children.
Exclusion Criteria:
- Presence of oral diseases, including periodontitis, salivary gland diseases, or oral mucosal diseases.
- History of autoimmune disease.
- Antibiotic use within the previous 3 months.
- Consumption of tannin-containing beverages (e.g., tea, coffee, or similar beverages) within the previous 1 month.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Group 1 (Erythritol Air-Polishing Using the EMS Air-Polishing Device)
|
Description: Participants assigned to Group 1 will receive professional removal of chromogenic tooth staining using ultrasonic scaling followed by erythritol air-polishing with the EMS air-polishing device, guided by a plaque-disclosing agent.
At the end of the procedure, the investigator will record the treatment time, apply the plaque-disclosing agent, obtain intraoral photographs, and assess chromogenic tooth staining using the Qraycam.
|
|
Aktiv komparator: Group 2 (Conventional Polishing Using Prophylaxis Paste and a Polishing Brush)
|
Participants will undergo professional tooth cleaning using the ultrasonic scaler of the EMS device.
The tooth surfaces will then be polished using a polishing brush and prophylaxis paste.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Black Stain Score
Tidsramme: Baseline, immediately after polishing, 1 month, 2 months, 3 months, and 6 months
|
Black Stain Classification (Gasparetto et al., 2003) Score Description Clinical Characteristics 0 None No black pigmentation on the tooth surface.
Black Stain Classification (Zerman et al., 2024) Score Description A Pigmented lines or dots present only on the buccal surface. B Pigmented lines or dots present on both the buccal and lingual surfaces. C Pigmented lines or dots associated with dental caries. D Recurrent pigmented lines or dots. |
Baseline, immediately after polishing, 1 month, 2 months, 3 months, and 6 months
|
|
Participant Feedback
Tidsramme: Periprocedural
|
Pain perception during the procedure will be assessed using the Wong-Baker FACES Pain Rating Scale.
The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "hurts worst."
Higher scores indicate greater pain intensity (worse outcome).
|
Periprocedural
|
|
Time Session
Tidsramme: Periprocedural
|
The duration of treatment is noted and compared between groups
|
Periprocedural
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GBTvschromogenic
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .