CLASS II DIVISION 1 MALOCCLUSIONNCT07405905
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.
A study testing retraction of anterior teeth using mini implants placed at infrazygomatic crest. and retraction of anterior teeth using mini implants placed at interradicular sites. in people with CLASS II DIVISION 1 MALOCCLUSION, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- CLASS II DIVISION 1 MALOCCLUSION
- What is being tested?
- retraction of anterior teeth using mini implants placed at infrazygomatic crest. and retraction of anterior teeth using mini implants placed at interradicular sites.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences, Rohtak, Haryana 124001
Rohtak, Haryana, 124001
Dr sonal chowdhary, MDS, sonalsingla@rediffmail.com
About this study
Official title: MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST VERSUS INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
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.
Read more
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.
Read the detailed description
The present study is a randomized clinical trial , non-pharmacological, double blind, 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. The present study will be conducted in the Department of Orthodontics and Dentofacial Orthopaedics, in conjunction with the Department of Oral and Maxillofacial Surgery, P.G.I.D.S., Pt. B.D.Sharma University of Health Sciences, Rohtak. The study will be carried out after the institutional approval obtained from the ethical committee.
Inclusion criteria:- Non growing patients with 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.
Exclusion Criteria:- 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.
INFORMED CONSENT OF THE PATIENT AND AGREEMENT TO BE RANDOMIZED A valid, written informed consent of the patient or parent/ guardian and an agreement to be randomized will be obtained from the patient before registering the patient in this clinical study. Patient will be informed about all the theoretical risks and benefits of the intervention under test . The patient will be given 72 hours to discuss the study with his/her family and take the decision regarding participation in the study.
RANDOMIZATION \& ALLOCATION CONCEALMENT Randomization will be done by a person not involved in the trial using computer generated randomization list. The study subjects will be blinded regarding intervention group.
INTERVENTION AND DESIGN OF STUDY The main intervention in this prospective clinical study is the bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini-implants placed at infrazygomatic crest in group 1 (G1) and mini-implants placed at interradicular sites in group 2 (G2). The study consists of 2 groups with equal allocation of subjects in each group:- Group 1 (G1):- This group will 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.
Group 2 (G2):- This group will undergo bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at interradicular sites.
DATA COLLECTION The investigator will record the patient's name, address and contact number will be taken. Cephalometric radiographs will be recorded before placement of mini-implants and after 6 months of application of NiTi closed coil springs. These cephalometric radiographs will be analyzed and the relevant values will be entered in a predesigned format.
Patients will be asked to fill a questionnaire in which they will be asked about problems they might have while eating, talking ,laughing, yawning swallowing ,drinking ,brushing and also the pain experienced in tooth ,jaws, muscles, headache, swelling ,soft tissue ulceration ,restricted mouth opening ,and level of satisfaction .These questionnaires will be completed on the evening after force application and at 7 days ,14 days ,1 month and 6 months. .
In addition orthodontist's perceptions will be assessed during handling complexity of mini implant in both the positions on same day,1 month, 3 months and 6 months following orthodontic force application.
STATISTICAL ANALYSIS The data entered will be processed by standard statistical analysis. Results will be presented in the form of tables and graphs.
The data will be subjected to descriptive analysis for mean, standard deviation for quantitative and proportion for qualitative variables. Shapiro Wilk test will be used to check the normality of distribution.
Independent T test (normal distribution) and Mann Whitney U test (Non-normal distribution ) will be used to compare means between two groups at pre-retraction stage. Dependent T test (normal distribution) or Wilcoxon Signed Ranks(Non-normal distribution) test will be used to compare changes within groups. Independent T test and Mann Whitney U tests will be used to compare change between two groups i.e. Group 1 (Infrazygomatic mini-implant) and Group 2 (Interradicular mini-implant). In all the analysis, the level of significance will be set a 5 percent.
Patient pain perception and orthodontist perception regarding treatment has been evaluated using chi square test.
- Conditions
- CLASS II DIVISION 1 MALOCCLUSION
- Being tested
- retraction of anterior teeth using mini implants placed at infrazygomatic crest., retraction of anterior teeth using mini implants placed at interradicular sites.
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retraction of anterior teeth using mini implants placed at infrazygomatic crest.Procedure or surgery
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.
retraction of anterior teeth using mini implants placed at interradicular sites.Procedure or surgery
bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at interradicular sites.
| Study group | Role | What they receive |
|---|---|---|
| Retraction of anterior teeth using mini implants placed at infrazygomatic crest. | Experimental | bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at infrazygomatic crest Receives: Procedure: retraction of anterior teeth using mini implants placed at infrazygomatic crest. |
| Retraction of anterior teeth using mini implants placed at interradicular sites. | Experimental | bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at interradicular sites. Receives: Procedure: retraction of anterior teeth using mini implants placed at interradicular sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- SNA: SN to NA angle
- A-NPerp: linear distance from A-point to nasion-perpendicular(a line perpendicular to Frankfort plane, through nasion)
- SNB: SN to NB angle
- SND: SN to ND angle
- LAFH (lower anterior face height): distance from anterior nasal spine to menton.
Dental cephalometric variables
- Mx1.NA: maxillary incisor long axis to NA angle
- Mx1-NA: distance between the maxillary central incisor edge and the NA line
- 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)
- Mx6-VRL: distance from maxillary first molar mesial cusp to VRL
- Md1.NB: mandibular incisor long axis to NB angle
- Md1-NB: distance between the mandibular central incisor edge and the NB line.
Measured: 15 months
Secondary outcomes (1)
soft tissue variables between the two groups
Comparison of pretreatment and post 6 month evaluation of soft tissue variables between the two groups
- LL-E plane: distance from the lower lip to the esthetic plane of Ricketts (line from Pg= to Pr)
- UL-E plane: distance from the upper lip to the esthetic plane of Ricketts
- UL-S line: distance from the upper lip to Steiner's S line (line from Pg= to Cl)
- LL-S line: distance from the lower lip to Steiner's S line
- UL-SnPg: distance from the upper lip to the subnasale-soft-tissue pogonion plane (line from Sn to Pg)
- LL-SnPg: distance from the lower lip to the subnasale-soft-tissue pogonion plane
- H.NB: H line (tangent to Pg= and UL) to NB line angle
- H-Pr: distance between H line and the most anterior point on the nose
- Nasolabial angle: Cl.Sn.UL angle
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLASS II DIVISION 1 MALOCCLUSIONStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonal chowdhary, MDS, Study director, Post Graduate Institute of Dental Sciences, Rohtak, Haryana 124001 Recruiting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405905
- Sponsor's protocol ID
- SONAL NAYAN
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST VERSUS INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
- ClinicalTrials.gov ID
- NCT07405905
- Acronym / sponsor ID
- SONAL NAYAN
- Conditions
- CLASS II DIVISION 1 MALOCCLUSION
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The present study is a randomized clinical trial , non-pharmacological, double blind, 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. The present study will be conducted in the Department of Orthodontics and Dentofacial Orthopaedics, in conjunction with the Department of Oral and Maxillofacial Surgery, P.G.I.D.S., Pt. B.D.Sharma University of Health Sciences, Rohtak. The study will be carried out after the institutional approval obtained from the ethical committee.
Inclusion criteria:- Non growing patients with 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.
Exclusion Criteria:- 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.
INFORMED CONSENT OF THE PATIENT AND AGREEMENT TO BE RANDOMIZED A valid, written informed consent of the patient or parent/ guardian and an agreement to be randomized will be obtained from the patient before registering the patient in this clinical study. Patient will be informed about all the theoretical risks and benefits of the intervention under test . The patient will be given 72 hours to discuss the study with his/her family and take the decision regarding participation in the study.
RANDOMIZATION \& ALLOCATION CONCEALMENT Randomization will be done by a person not involved in the trial using computer generated randomization list. The study subjects will be blinded regarding intervention group.
INTERVENTION AND DESIGN OF STUDY The main intervention in this prospective clinical study is the bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini-implants placed at infrazygomatic crest in group 1 (G1) and mini-implants placed at interradicular sites in group 2 (G2). The study consists of 2 groups with equal allocation of subjects in each group:- Group 1 (G1):- This group will 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.
Group 2 (G2):- This group will undergo bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at interradicular sites.
DATA COLLECTION The investigator will record the patient's name, address and contact number will be taken. Cephalometric radiographs will be recorded before placement of mini-implants and after 6 months of application of NiTi closed coil springs. These cephalometric radiographs will be analyzed and the relevant values will be entered in a predesigned format.
Patients will be asked to fill a questionnaire in which they will be asked about problems they might have while eating, talking ,laughing, yawning swallowing ,drinking ,brushing and also the pain experienced in tooth ,jaws, muscles, headache, swelling ,soft tissue ulceration ,restricted mouth opening ,and level of satisfaction .These questionnaires will be completed on the evening after force application and at 7 days ,14 days ,1 month and 6 months. .
In addition orthodontist's perceptions will be assessed during handling complexity of mini implant in both the positions on same day,1 month, 3 months and 6 months following orthodontic force application.
STATISTICAL ANALYSIS The data entered will be processed by standard statistical analysis. Results will be presented in the form of tables and graphs.
The data will be subjected to descriptive analysis for mean, standard deviation for quantitative and proportion for qualitative variables. Shapiro Wilk test will be used to check the normality of distribution.
Independent T test (normal distribution) and Mann Whitney U test (Non-normal distribution ) will be used to compare means between two groups at pre-retraction stage. Dependent T test (normal distribution) or Wilcoxon Signed Ranks(Non-normal distribution) test will be used to compare changes within groups. Independent T test and Mann Whitney U tests will be used to compare change between two groups i.e. Group 1 (Infrazygomatic mini-implant) and Group 2 (Interradicular mini-implant). In all the analysis, the level of significance will be set a 5 percent.
Patient pain perception and orthodontist perception regarding treatment has been evaluated using chi square test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retraction of anterior teeth using mini implants placed at infrazygomatic crest. | Experimental | Procedure: 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 infrazygomatic crest |
| Retraction of anterior teeth using mini implants placed at interradicular sites. | Experimental | Procedure: retraction of anterior teeth using mini implants placed at interradicular sites.bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at interradicular sites. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Subjects with a history of fixed orthodontic treatment.
- Crossbite
- Vertical growth pattern
- Any systemic disease affecting bone and general growth
- Poor oral hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retraction of anterior teeth using mini implants placed at infrazygomatic crest.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. | Procedure or surgery | Retraction of anterior teeth using mini implants placed at infrazygomatic crest. |
| retraction of anterior teeth using mini implants placed at interradicular sites.bilateral extraction of maxillary first premolars before initial leveling and alignment followed by retraction of anterior teeth using mini implants placed at interradicular sites. | Procedure or surgery | Retraction of anterior teeth using mini implants placed at interradicular sites. |
Primary outcome
skeletal and dental cephalometric variables
Time frame: 15 months
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.
1 secondary outcome
soft tissue variables between the two groups
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sonal chowdhary, MDS study director
Post Graduate Institute of Dental Sciences, Rohtak, Haryana 124001 Recruiting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retraction of anterior teeth using mini implants placed at infrazygomatic crest. and retraction of anterior teeth using mini implants placed at interradicular sites. in people with CLASS II DIVISION 1 MALOCCLUSION, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonal chowdhary, MDS (9992025599, sonalsingla@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skeletal and dental cephalometric variables (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.