Improving the Treatment Outcome Related to Inclination of Mandibular Incisors by Separating Aligning and Leveling Phases. (Alignment)
Improving the Treatment Outcome Related to Inclination of Mandibular Incisors by Separating Aligning and Leveling Phases During Fixed Orthodontic Treatment: A Randomized Clinical Trial
Study Summary
The goal of this clinical trial is to determine whether separating the aligning and leveling phases during fixed orthodontic treatment improves the treatment outcome related to the inclination of mandibular incisors in patients undergoing comprehensive orthodontic treatment.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Study Summary
The goal of this clinical trial is to determine whether separating the aligning and leveling phases during fixed orthodontic treatment improves the treatment outcome related to the inclination of mandibular incisors in patients undergoing comprehensive orthodontic treatment.
The main questions it aims to answer are:
Does separating the aligning and leveling phases result in better control of mandibular incisor inclination compared with the conventional simultaneous approach? Does the modified treatment approach reduce unwanted proclination of mandibular incisors during the initial phase of orthodontic treatment?
Researchers will compare patients treated with a separated aligning and leveling protocol to those treated with the conventional simultaneous aligning and leveling protocol to determine whether the modified approach provides superior control of mandibular incisor inclination.
Participants will:
Undergo a clinical examination and baseline orthodontic records, including dental casts and lateral cephalometric radiographs.
Be randomly assigned to either the experimental (separated aligning and leveling) group or the conventional treatment group.
Receive fixed orthodontic treatment according to the allocated treatment protocol.
Attend regular follow-up appointments for archwire changes and treatment monitoring.
Undergo post-treatment assessment of mandibular incisor inclination and other relevant treatment outcomes using lateral cephalometric radiographs.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75300
- Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients aged 18-30 years age
- Skeletal Class 1
- Angle class 1 malocclusion
- Little's irregularity index falls between 4-8mm
- Curve of spee depth 3-4mm
- Non-extraction Orthodontic plan
Exclusion Criteria:
- Previous Orthodontic treatment
- Advanced periodontal problem
- Drug used that modify bone metabolism
- Growing patients
- Patient with anterior mandibular spacing
- Systemic Disease (uncontrolled diabetes Mellitus etc )
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: separated phases of leveling and alignment
Separated phases of leveling and alignment using heat activated niti archwires
|
6 months
|
|
Ingen inngripen: Combined leveling alignment
Combined levelling and alignment
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
to Control mandibular incisor inclination
Tidsramme: 6 months
|
control mandibular incisor inclination using heat activated niti archwire.
It will be checked through cephalometric radiographs using the angles: Incisor Mandibular Plane Angle (IMPA) at T0: baseline, T1: 3 months follow up and T2: 6 month follow up.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
TO flatten curve of spee
Tidsramme: 6 months
|
Flattening of curve of spee using heat activated niti archwires.
It will be checked at cast by placing a flat object on the occlusal surface and measuring the deepest point from the premolar to the flat surface at T0: baseline, T1: 3 months follow up and T2: 6 month follow up.
|
6 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
to check alignment
Tidsramme: 6 months
|
to check alignment of lower incisors through littles irregularity index
|
6 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Sadia Rizwan, BDS, FCPS, CHPE, Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
- Dr Sadaf Zehra
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Studiedata/dokumenter
-
Studieprotokoll
Informasjonsidentifikator: shahsadaf939@gmail.comInformasjonskommentarer: will be provided upon request
Legemiddel- og utstyrsinformasjon, studiedokumenter
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