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Improving the Treatment Outcome Related to Inclination of Mandibular Incisors by Separating Aligning and Leveling Phases.

Improving the Treatment Outcome Related to Inclination of Mandibular Incisors by Separating Aligning and Leveling Phases During Fixed Orthodontic Treatment: A Randomized Clinical Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07733258
Acronym
Alignment
Enrollment
36
Registered
2026-07-29
Start date
2023-10-10
Completion date
2024-10-08
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alignment, Leveling and Alignment of Teeth

Keywords

alignment, leveling, archwire, fixed orthodontic treatment

Brief summary

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.

Detailed description

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.

Interventions

OTHERSeparating phases of alignment and leveling using heat activated niti archwire

6 months

Sponsors

Dow University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

two arm parallel

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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 )

Design outcomes

Primary

MeasureTime frameDescription
to Control mandibular incisor inclination6 monthscontrol 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.

Secondary

MeasureTime frameDescription
TO flatten curve of spee6 monthsFlattening 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.

Countries

Pakistan

Contacts

STUDY_DIRECTORSadia Rizwan, BDS, FCPS, CHPE

Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026