EVALUATION OF TREATMENT CHANGES IN CLASS II DIVISION 1 MALOCCLUSION DURING EN MASSE RETRACTION OF UPPER ANTERIOR TEETH USING MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST AND INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST VERSUS INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
1 other identifier
interventional
30
1 country
1
Brief Summary
Rationale: Class II Division 1 malocclusion is characterized by upper anterior teeth protrusion resulting in upper lip protrusion and convex facial profile, which are considered esthetically unfavorable. Treatment of class II malocclusion due to maxillary protrusion can be done with bilateral maxillary first premolar extraction followed by en-masse retraction of upper anterior teeth using mini-implants placed at infrazygomatic or interradicular sites. Aims and Objectives: To evaluate the treatment changes achieved in class II division 1 malocclusion during en- masse retraction of upper anterior teeth using mini-implants placed at infrazygomatic crest versus interradicular sites. To compare patients' and orthodontist's perceptions of treatment being done in both the groups. Method of study: Treatment will be initiated by bilateral maxillary 1st premolar extraction followed by bonding 0.022" slot MBT preadjusted edgewise appliance. Maxillary arch will be stabilized with the help of 0.019"×0.025" stainless steel wire and then randomized allocation of the patients into 2 groups-G1 and G2 will be done. G1 will receive infrazygomatic crest mini-implants bilaterally and G2 will receive bilateral interradicular mini-implants. Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring will be used to apply force.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2025
CompletedFirst Submitted
Initial submission to the registry
January 30, 2026
CompletedFirst Posted
Study publicly available on registry
February 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
February 12, 2026
February 1, 2026
1.2 years
January 30, 2026
February 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
skeletal and dental cephalometric variables
Comparison of pretreatment and post 6 month evaluation of skeletal and dental cephalometric variables between the two groups Skeletal cephalometric variables 1. SNA: SN to NA angle 2. A-NPerp: linear distance from A-point to nasion-perpendicular(a line perpendicular to Frankfort plane, through nasion) 3. SNB: SN to NB angle 4. SND: SN to ND angle 5. LAFH (lower anterior face height): distance from anterior nasal spine to menton. Dental cephalometric variables 1. Mx1.NA: maxillary incisor long axis to NA angle 2. Mx1-NA: distance between the maxillary central incisor edge and the NA line 3. Mx1-VRL: distance from the maxillary central incisor edge to VRL (vertical reference line passing through sella and perpendicular to horizontal line constructed by reducing 7° from SN line) 4. Mx6-VRL: distance from maxillary first molar mesial cusp to VRL 5. Md1.NB: mandibular incisor long axis to NB angle 6. Md1-NB: distance between the mandibular central incisor edge and the NB line.
15 months
Secondary Outcomes (1)
soft tissue variables between the two groups
15 months
Other Outcomes (2)
patient attitude and pain perception
15 months
orthodontic perception
15 months
Study Arms (2)
Retraction of anterior teeth using mini implants placed at infrazygomatic crest.
EXPERIMENTALbilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at infrazygomatic crest
Retraction of anterior teeth using mini implants placed at interradicular sites.
EXPERIMENTALbilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at interradicular sites.
Interventions
undergo bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at infrazygomatic crest.
bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at interradicular sites.
Eligibility Criteria
You may qualify if:
- Non growing patients
- Bilateral Class II molar relationship at pre-treatment.
- All permanent teeth upto the second molars should be present.
- No or minor crowding in the maxillary arch.
- Horizontal to average growth pattern.
You may not qualify if:
- Subjects with a history of fixed orthodontic treatment.
- Crossbite
- Vertical growth pattern
- Any systemic disease affecting bone and general growth
- Poor oral hygiene
- Cleft patients
- Patients who fail to follow up or undergo complete treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Dental Sciences, Rohtak, Haryana 124001
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sonal chowdhary, MDS
Post Graduate Institute of Dental Sciences, Rohtak, Haryana 124001 Recruiting
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2026
First Posted
February 12, 2026
Study Start
October 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL