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.
