- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07617480
Comparison of Orthodontic Bracket Bond Failure Using Acid Etching With or Without Sandblasting (AE SBE BF BB)
Comparison of Orthodontic Bracket Bond Failure Using Acid Etching With or Without Sandblasting Method for the Preparation of Enamel
The goal of this clinical trial is to assess if sandblasting before acid etching reduce orthodontic bracket bond failure in fixed orthodontic treatment. The main question it aims to answer is:
• What are the differences in bracket bond failure rate between acid etching with or without sandblasting method for the preparation of enamel? Researchers will compare acid etching with sandblasting method to acid etching without sandblasting method for enamel preparation to see if sandblasting prior to acid etching reduce bracket bond failure rate.
Participants will:
- Receive sandblasting of enamel before acid etching on one side of the mouth and only acid etching on the contralateral side for enamel preparation.
- Participants would visit at the the OPD of Hospital at 3 weeks interval for follow up and for a total duration of 4 months to assess the changes. The number of bracket bond dislodgements at each session will be recorded .
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Dhaka, Bangladesh, 1000
- Bangladesh Medical University
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Participants with good general health condition and oral hygiene status.
- Age range of the patients will be 18 years and above.
- Sex of the participants will be both male and female.
- Patients with full permanent dentition present (excluding 3rd molar).
- Patients with enamel integrity, absence of traumatic or carious lesion.
- Participants who had no enamel pretreatment procedure performed with chemical agents.
- Participants with no crossbite, scissor bite or occlusal interference (to prevent any potential early bond failure).
Exclusion Criteria:
- Patients who have congenital enamel defects,
- Patients who are in need of orthognathic surgery.
- Patients with craniofacial syndromes.
- Patients who present with partially erupted teeth with hypoplasia.
- Patients for whom a rapid expander or a fixed functional appliance will be planned.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Sandblasting
Sandblasting will be applied onto the vestibular surfaces of the teeth before applying the etchant
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Sandblasting will be applied onto the vestibular surfaces of the teeth before applying the etchant;
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Aktiv komparator: Acid Etching Alone
Only acid etching will be applied onto the vestibular surfaces of the teeth for enamel preparation.
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Acid etching will be applied onto the vestibular surfaces of the teeth for enamel preparation.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To compare the bracket bond failure rate using acid etching with or without sandblasting method for the preparation of enamel.
Tidsramme: 6 months
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6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Mahmood Sajedeen, BDS, FCPS, Bangladesh Medical University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
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
Andre studie-ID-numre
- BMU/2026/1641 (Annen identifikator: Bangladesh Medical University (BMU))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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