Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws
18. juni 2026 opdateret af: Tanzila Rafique
Factors Associated With the Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws
The goal of this randomized clinical study is to assess the factors associated with the failure rate of infra-zygomatic crest orthodontic mini-screws used for anchorage reinforcement during orthodontic treatment.
Studieoversigt
Status
Tilmelding efter invitation
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Researchers will evaluate the influence of mini-screw length, diameter, oral hygiene status, age, sex, and loading time on the failure rate of infra-zygomatic mini-screws. Mini-screw failure will be assessed clinically by the presence of mobility or loss of stability.
Participants will:
- Receive fixed orthodontic treatment with a pre-adjusted edgewise appliance system.
- Receive infra-zygomatic mini-screws bilaterally for maxillary anchorage reinforcement.
- Receive a 10 mm × 1.8 mm mini-screw on one side with immediate loading.
- Receive a 12 mm × 2.0 mm mini-screw on the contralateral side with delayed loading.
- Receive standardized orthodontic force using elastic power chain.
- Undergo CBCT assessment to evaluate the position of the inserted mini-screws.
- Be evaluated at baseline and at one-month intervals for three consecutive months to assess mini-screw mobility or failure.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Dhaka, Bangladesh, 1000
- Bangladesh Medical University (BMU), Dhaka,1000
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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
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Participants aged 19 to 35 years.
- Both male and female participants.
- Patients requiring absolute anchorage for maxillary arch and orthodontic tooth movement.
- Patients undergoing fixed orthodontic treatment.
- Patients in whom infra-zygomatic mini-screws are indicated for anchorage reinforcement.
- Participants whose oral hygiene status can be clinically assessed.
- Participants willing to provide written informed consent.
Exclusion Criteria:
- Patients with incomplete history or records
- Patients with a history of previous orthodontic treatment.
- Patients with a history of maxillofacial surgery.
- Patients with a history of head or facial trauma.
- Patients with temporomandibular joint disorder.
- Medically compromised patients.
- Patients with diagnosed syndromes, congenital defects, or facial deformities.
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 |
|---|---|
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Aktiv komparator: Immediate loading mini-screw group
A 10 mm length and 1.8 mm diameter infra-zygomatic mini-screw will be placed on one side of the maxillary arch and loaded immediately with orthodontic force.
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A 10 mm length and 1.8 mm diameter infra-zygomatic mini-screw will be placed on one side of the maxillary arch and loaded immediately with orthodontic force.
|
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Aktiv komparator: Delayed loading mini-screw group
A 12 mm length and 2.0 mm diameter infra-zygomatic mini-screw will be placed on the contralateral side of the maxillary arch and loaded after a delayed period.
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A 12 mm length and 2.0 mm diameter infra-zygomatic mini-screw will be placed on the contralateral side of the maxillary arch and loaded after a delayed period
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To assess the failure rate of infra-zygomatic orthodontic mini-screws over a three-month follow-up period. Failure will be defined as any degree of clinical mobility or loss of stability of the mini-screw.
Tidsramme: over a three-month follow-up period
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This is a split-mouth randomized clinical study in which each participant will receive infra-zygomatic mini-screws bilaterally.
One side will receive a 10 mm × 1.8 mm mini-screw with immediate loading, while the contralateral side will receive a 12 mm × 2.0 mm mini-screw with delayed loading.
The failure rate will be assessed clinically over a three-month follow-up period.Mini-screw failure will be assessed clinically by the presence of mobility or loss of stability.
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over a three-month follow-up period
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To assess the failure rate of infra-zygomatic orthodontic mini-screws over a three-month follow-up period. Failure will be defined as any degree of clinical mobility or loss of stability of the mini-screw
Tidsramme: Over a three-month follow-up period.
|
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Over a three-month follow-up period.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Factors Associated with the Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws
Tidsramme: From October 25 to September 26
|
This randomized clinical study will assess the factors associated with the failure rate of infra-zygomatic crest orthodontic mini-screws used for anchorage reinforcement during orthodontic treatment. Researchers will evaluate the influence of mini-screw length, diameter, oral hygiene status, age, sex, and loading time on the failure rate of infra-zygomatic mini-screws. Mini-screw failure will be assessed clinically by the presence of mobility or loss of stability. Participants will receive:
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From October 25 to September 26
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Mahmood Sajedeen, BDS,FCPS, Bangladesh Medical University (BMU)
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)
1. september 2025
Primær færdiggørelse (Anslået)
30. december 2026
Studieafslutning (Anslået)
8. februar 2027
Datoer for studieregistrering
Først indsendt
11. juni 2026
Først indsendt, der opfyldte QC-kriterier
18. juni 2026
Først opslået (Faktiske)
22. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- BMU/2026/1583
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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