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Root Resorption in Class II Div 1 Malocclusion in Upper 1st Premolar Extraction vs Distalization

Primary Purpose

Class II Div 1 Malocclusion

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
maxillary Ist premolar extraction
SURGICAL
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Div 1 Malocclusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. 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

Sites / Locations

  • Sonal ChowdharyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

EXTRACTION OF MAXILLARY IST PREMOLARS

DISTALIZATION

Arm Description

Experimental: EXTRACTION treatment of class II div 1 malocclusion with bilateral maxillary premolar extraction

Experimental: DISTALIZATION treatment of class II div 1 malocclusion with distalization using zygomatic miniplates

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

patient and orthodontist perception
patient and orthodontist perception in both the groups has been evaluated using Visual Analogue Scale

Full Information

First Posted
November 12, 2022
Last Updated
November 28, 2022
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05639725
Brief Title
Root Resorption in Class II Div 1 Malocclusion in Upper 1st Premolar Extraction vs Distalization
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Div 1 Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EXTRACTION OF MAXILLARY IST PREMOLARS
Arm Type
Experimental
Arm Description
Experimental: EXTRACTION treatment of class II div 1 malocclusion with bilateral maxillary premolar extraction
Arm Title
DISTALIZATION
Arm Type
Experimental
Arm Description
Experimental: DISTALIZATION treatment of class II div 1 malocclusion with distalization using zygomatic miniplates
Intervention Type
Procedure
Intervention Name(s)
maxillary Ist premolar extraction
Intervention Description
Procedure/Surgery: Patients will undergo bilateral maxillary 1st premolars extraction before bonding followed by leveling & alignment.
Intervention Type
Procedure
Intervention Name(s)
SURGICAL
Intervention Description
Surgery:After leveling and alignment,placement of zygomatic miniplates in bilaterally
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
34 MONTHS
Secondary Outcome Measure Information:
Title
patient and orthodontist perception
Description
patient and orthodontist perception in both the groups has been evaluated using Visual Analogue Scale
Time Frame
34 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DR. SONAL CHOWDHARY, MDS
Phone
9992025599
Email
sonalsingla@rediffmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
DR.VIRENDER SINGH, MDS
Facility Information:
Facility Name
Sonal Chowdhary
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SONAL CHOWDHARY, MDS
Phone
9992025599
Email
sonalsingla@rediffmail.com
First Name & Middle Initial & Last Name & Degree
SONAL CHOWDHARY, MDS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
STUDY PROTOCOL

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Root Resorption in Class II Div 1 Malocclusion in Upper 1st Premolar Extraction vs Distalization

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