Class II Div 1 MalocclusionNCT05639725
Root Resorption in Class II Div 1 Malocclusion in Upper 1st Premolar Extraction vs Distalization
A study testing maxillary Ist premolar extraction and SURGICAL in people with Class II Div 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 years and olderHealthy volunteers can take part
- Conditions the study is for
- Class II Div 1 Malocclusion
- What is being tested?
- maxillary Ist premolar extraction and SURGICAL
- 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
- 15 Jun 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non growing patients
- Complete 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.
DR.VIRENDER SINGH, MDS contact
India1 site, 1 recruiting
- Recruiting
Sonal Chowdhary
Rohtak, Haryana, 124001
SONAL CHOWDHARY, MDS, 9992025599, sonalsingla@rediffmail.com
SONAL CHOWDHARY, MDS
About this study
Official title: A Comparative Evaluation of Root Resorption Using CBCT, Patients and Orthodontists Perceptions in Class II Division I Malocclusion With Bilateral Extraction of Maxillary First Premolar vs Full Arch Distalization : 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 between maxillary 2nd premolar \& 1st molar.
Treatment of class II malocclusion due to maxillary protrusion without premolar extraction frequently requires distalization of maxillary molars into Class I molar relation by means of extra-oral or intraoral forces. Absolute skeletal anchorage, available 24 hours a day is an alternative method for molar distalization. Zygomatic miniplates fixed at a distance from the root apices, allows distalization of entire dentition as there is no interference between the fixation device and roots of the teeth.
Read more
Aims and Objectives: To quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en - masse retraction of anterior teeth) vs full arch distalization with zygomatic miniplates in Class II Division I malocclusion.
Method of study: Patients will be allocated randomly to 2 groups-G1 and G2. Patients in G1 will undergo bilateral maxillary 1st premolar extraction before bonding followed by leveling \& alignment. Maxillary arch will be stabilized with the help of 0.019"×0.025" stainless steel wire. Hooks will be soldered on archwire used for stabilizing dentition. Mini implants will be placed under local anaesthesia between maxillary 2nd premolar \& 1st molar. Ni-Ti closed coil spring will be used to apply a force for en masse retraction of maxillary anterior teeth .
In G2, treatment will be initiated 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. Zygomatic miniplates will be placed bilaterally. Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring will be used to apply a force .
Read the detailed description
The present study is a prospective, non-pharmacological, single blind, randomized clinical study to quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en - masse retraction of anterior teeth) vs full arch distalization with zygomatic miniplates in Class II Division I malocclusion. 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.
SOURCE OF DATA The study sample consists of 30 subjects selected from the patients attending the regular OPD at the Department of Orthodontics and Dentofacial Orthopaedics for orthodontic treatment.
Patients who fail to follow up or undergo complete treatment TARGET SAMPLE SIZEA sample size of 14 per group for the present study was calculated to detect a clinical difference of 0.25 with a pooled standard deviation of 0.2 (effect size 1.56) at 90% power and 95% confidence interval.
To compensate for 10% dropouts the final sample size was calculated to be 15 per group.
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 (Annexure I). 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 extraction of bilateral maxillary first premolars before initial leveling and alignment with retraction of anterior teeth using mini implants in first group (G1) and is the placement of zygomatic miniplates after initial leveling and alignment of maxillary dental arch in second group(G2) . The study consists of 2 groups with equal allocation of subjects in each group:- Group 1 (G1):- In this group, bilateral maxillary 1st premolars will be extracted followed by Levelling \& alignment with 0.022" MBT preadjusted edgewise appliance. Maxillary arch will be stabilized with the help of 0.019" × 0.025" stainless steel wire. Placement of Mini implants bilaterally between maxillary 2nd premolar \& 1st molar under LA. Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring will be used to apply force . Regular follow up of the patient will be done and records including cephalograms and study models will be taken post 6 months of application of NiTi closed coil spring Group 2 (G2):- In this group treatment will be initiated with 0.022" MBT preadjusted edgewise appliance. Maxillary arch will be stabilized with the help of 0.019" × 0.025" stainless steel wire. After that, bilateral Maxillary third molar will be extracted, if present followed by placement of zygomatic miniplates bilaterally under LA.Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring will be used to apply force . Regular follow up of the patient will be done and records including cephalograms and study models will be taken post 6 months of application of NiTi closed coil spring DATA COLLECTION The investigator will record the patient's name, address and contact number and other relevant case history records (Annexure II) will be taken. CBCTwill be recorded before treatment and after completion of tratment to evaluate root resorprion. The relevant values will be entered in a predesigned format. (Annexure III, IV).
STATISTICAL ANALYSIS The data will be entered into Microsoft Excel and analyzed using SPSS 21(Statistical Package For Social Sciences) package for relevant statistical comparison. Results will be presented in the form of tables and graphs.
Descriptive statistics and inferential statistics will be used. Data will be checked for normality. In all the analysis, the level of significance will be set a 5 percent.
- Conditions
- Class II Div 1 Malocclusion
- Being tested
- maxillary Ist premolar extraction, SURGICAL
- 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.
maxillary Ist premolar extractionProcedure or surgery
Procedure/Surgery: Patients will undergo bilateral maxillary 1st premolars extraction before bonding followed by leveling \& alignment.
SURGICALProcedure or surgery
Surgery:After leveling and alignment,placement of zygomatic miniplates in bilaterally
| Study group | Role | What they receive |
|---|---|---|
| EXTRACTION OF MAXILLARY IST PREMOLARS | Experimental | Experimental: EXTRACTION treatment of class II div 1 malocclusion with bilateral maxillary premolar extraction Receives: Procedure: maxillary Ist premolar extraction |
| DISTALIZATION | Experimental | Experimental: DISTALIZATION treatment of class II div 1 malocclusion with distalization using zygomatic miniplates Receives: Procedure: SURGICAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.To quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en-masse retraction of anterior teeth) vs maxillary full arch distalization using zygomatic miniplates in Class II division 1 malocclusion.
pre treatment and post treatment cbct has been assessed to measure the root resorption of maxillary teeth in millimetres 2. To compare both patients' and orthodontist's perceptions of treatment being done in both the groups.
Measured: 34 MONTHS
Secondary outcomes (1)
patient and orthodontist perception
patient and orthodontist perception in both the groups has been evaluated using Visual Analogue Scale
Measured: 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start15 Jun 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Div 1 MalocclusionStudies of the same condition, open and under way.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639725
- Sponsor's protocol ID
- SONAL RAVEENA
- Status last verified
- Nov 2022
- First submitted
- 12 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: STUDY PROTOCOL
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Root Resorption Using CBCT, Patients and Orthodontists Perceptions in Class II Division I Malocclusion With Bilateral Extraction of Maxillary First Premolar vs Full Arch Distalization : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05639725
- Acronym / sponsor ID
- SONAL RAVEENA
- Conditions
- Class II Div 1 Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 6 Dec 2022 (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 between maxillary 2nd premolar \& 1st molar.
Treatment of class II malocclusion due to maxillary protrusion without premolar extraction frequently requires distalization of maxillary molars into Class I molar relation by means of extra-oral or intraoral forces. Absolute skeletal anchorage, available 24 hours a day is an alternative method for molar distalization. Zygomatic miniplates fixed at a distance from the root apices, allows distalization of entire dentition as there is no interference between the fixation device and roots of the teeth.
Aims and Objectives: To quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en - masse retraction of anterior teeth) vs full arch distalization with zygomatic miniplates in Class II Division I malocclusion.
Method of study: Patients will be allocated randomly to 2 groups-G1 and G2. Patients in G1 will undergo bilateral maxillary 1st premolar extraction before bonding followed by leveling \& alignment. Maxillary arch will be stabilized with the help of 0.019"×0.025" stainless steel wire. Hooks will be soldered on archwire used for stabilizing dentition. Mini implants will be placed under local anaesthesia between maxillary 2nd premolar \& 1st molar. Ni-Ti closed coil spring will be used to apply a force for en masse retraction of maxillary anterior teeth .
In G2, treatment will be initiated 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. Zygomatic miniplates will be placed bilaterally. Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring will be used to apply a force .
Detailed description
The present study is a prospective, non-pharmacological, single blind, randomized clinical study to quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en - masse retraction of anterior teeth) vs full arch distalization with zygomatic miniplates in Class II Division I malocclusion. 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.
SOURCE OF DATA The study sample consists of 30 subjects selected from the patients attending the regular OPD at the Department of Orthodontics and Dentofacial Orthopaedics for orthodontic treatment.
Patients who fail to follow up or undergo complete treatment TARGET SAMPLE SIZEA sample size of 14 per group for the present study was calculated to detect a clinical difference of 0.25 with a pooled standard deviation of 0.2 (effect size 1.56) at 90% power and 95% confidence interval.
To compensate for 10% dropouts the final sample size was calculated to be 15 per group.
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 (Annexure I). 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 extraction of bilateral maxillary first premolars before initial leveling and alignment with retraction of anterior teeth using mini implants in first group (G1) and is the placement of zygomatic miniplates after initial leveling and alignment of maxillary dental arch in second group(G2) . The study consists of 2 groups with equal allocation of subjects in each group:- Group 1 (G1):- In this group, bilateral maxillary 1st premolars will be extracted followed by Levelling \& alignment with 0.022" MBT preadjusted edgewise appliance. Maxillary arch will be stabilized with the help of 0.019" × 0.025" stainless steel wire. Placement of Mini implants bilaterally between maxillary 2nd premolar \& 1st molar under LA. Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring will be used to apply force . Regular follow up of the patient will be done and records including cephalograms and study models will be taken post 6 months of application of NiTi closed coil spring Group 2 (G2):- In this group treatment will be initiated with 0.022" MBT preadjusted edgewise appliance. Maxillary arch will be stabilized with the help of 0.019" × 0.025" stainless steel wire. After that, bilateral Maxillary third molar will be extracted, if present followed by placement of zygomatic miniplates bilaterally under LA.Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring will be used to apply force . Regular follow up of the patient will be done and records including cephalograms and study models will be taken post 6 months of application of NiTi closed coil spring DATA COLLECTION The investigator will record the patient's name, address and contact number and other relevant case history records (Annexure II) will be taken. CBCTwill be recorded before treatment and after completion of tratment to evaluate root resorprion. The relevant values will be entered in a predesigned format. (Annexure III, IV).
STATISTICAL ANALYSIS The data will be entered into Microsoft Excel and analyzed using SPSS 21(Statistical Package For Social Sciences) package for relevant statistical comparison. Results will be presented in the form of tables and graphs.
Descriptive statistics and inferential statistics will be used. Data will be checked for normality. In all the analysis, the level of significance will be set a 5 percent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXTRACTION OF MAXILLARY IST PREMOLARS | Experimental | Procedure: maxillary Ist premolar extractionExperimental: EXTRACTION treatment of class II div 1 malocclusion with bilateral maxillary premolar extraction |
| DISTALIZATION | Experimental | Procedure: SURGICALExperimental: DISTALIZATION treatment of class II div 1 malocclusion with distalization using zygomatic miniplates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non growing patients
- Complete 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 |
|---|---|---|
| maxillary Ist premolar extractionProcedure/Surgery: Patients will undergo bilateral maxillary 1st premolars extraction before bonding followed by leveling \& alignment. | Procedure or surgery | EXTRACTION OF MAXILLARY IST PREMOLARS |
| SURGICALSurgery:After leveling and alignment,placement of zygomatic miniplates in bilaterally | Procedure or surgery | DISTALIZATION |
Primary outcome
1.To quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en-masse retraction of anterior teeth) vs maxillary full arch distalization using zygomatic miniplates in Class II division 1 malocclusion.
Time frame: 34 MONTHS
pre treatment and post treatment cbct has been assessed to measure the root resorption of maxillary teeth in millimetres 2. To compare both patients' and orthodontist's perceptions of treatment being done in both the groups.
1 secondary outcome
patient and orthodontist perception
Time frame: 34 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: Yes. STUDY PROTOCOL
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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. This study is not recruiting at the moment.
DR.VIRENDER SINGH, MDS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maxillary Ist premolar extraction and SURGICAL in people with Class II Div 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DR. 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?
1.To quantify root resorption seen with bilateral extraction of maxillary first premolars (followed by en-masse retraction of anterior teeth) vs maxillary full arch distalization using zygomatic miniplates in Class II division 1 malocclusion. (time frame: 34 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 6 Dec 2022.