- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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MALTEPE
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Istanbul, MALTEPE, Türkei (türkiye), 34854
- Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi
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Kontakt:
- Betul Sen Yavuz
- Telefonnummer: +90 539 988 76 46
- E-Mail: dtbetulsen@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Group 1 (Erythritol Air-Polishing Using the EMS Air-Polishing Device)
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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.
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Aktiver Komparator: Group 2 (Conventional Polishing Using Prophylaxis Paste and a Polishing Brush)
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Black Stain Score
Zeitfenster: Baseline, immediately after polishing, 1 month, 2 months, 3 months, and 6 months
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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
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Participant Feedback
Zeitfenster: Periprocedural
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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).
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Periprocedural
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Time Session
Zeitfenster: Periprocedural
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The duration of treatment is noted and compared between groups
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Periprocedural
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GBTvschromogenic
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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