Material And Methodology

This prospective study will be conducted in the department of Orthodontics and dentofacial orthopedics in AIIMS Jodhpur. Patients will be recruited from orthodontic OPD of the hospital.

Sample selection criteria:-

1.          Treatment plan including extraction of the maxillary or mandibular premolars.      
2.          Fixed appliance treatment requiring Elastomeric Separator placement.
3.          Patients in need of anchorage reinforcement â€“ ( Microimplant anchorage).
4.          Permanent dentition including the maxillary second molars in occlusion.
5.          Patients requiring en-mass retraction to reduce excessive overjet.
6.          Patients between the age group of 13 and 25 years.
7.          Teeth with good gingival health.
8.          Teeth free from pathological conditions.

1.          Patients who had undergone previous active orthodontic treatment.
2.          Patients having any orofacial pain prior to treatment.
3.          Patients having TMJ disorders.
4.          Patients with systemic diseases.
5.          Patients under medications that interfere with bone metabolism and gingival tissue health.
6.          Patients with Compromised mental health.
7.          Patients with Poor oral hygiene.
8.          Patients having Ill habits like smoking.
9.          Patients having Gingival and periodontal diseases like gingivitis, periodontitis.
 

 Tooth extractions will be performed according to the following protocol:
1. Topical anesthesia with 5% lidocaine gel.
2. Buccal and palatal infiltration of Xylocaine Dental Adrenalin (lidocaine hydrochloride 20 mg/mL, adrenaline12.5 microg/mL).
3. Tooth extraction after careful mobilization. 

1)       Elastomeric separators of 2.5mm diameter are placed over the end of the separator plier
2)       Separators are squeezed into mesial and distal interdental area of maxillary and mandibular first molars in each quadrant.
3)       Extreme care is needed in holding the plier, so that it does not slip and cause injury.

All miniscrews will be inserted according to the following protocol:
1.       Topical anesthesia with lidocaine gel.
2.       Buccal infiltration of 0.3 mL Xylocaine Dental Adrenalin per site (lidocaine hydrochloride 20 mg/mL,adrenaline 12.5 lg/mL).
3.       Chlorhexidine mouth rinse for 60 seconds.
4.       Insertion of miniscrews buccally and interdentally.
5.       Periapical radiographs.
6.       After screw insertion, patients were instructed to apply chlorhexidine gel onto the miniscrews once a day for 2 weeks.

Methodology

Sample Size Calculation:

Assuming a Standard deviation of 22.37 and 25.48 in two treatment groups with absolute difference in mean VAS (Mean VAS scores at day 1 of separator and micro implant group) of 13 in two treatment groups and an effect size of 0.54 and power of 80% with clinically significance level of 0.05, a sample size of 53 patients per treatment group will be needed. The above data has been derived from the study of Lee et al. With a dropout rate of about 5 %, 56 patients will be required to be included in each treatment group. If there is no dropout, then 53 patients per treatment group will be enrolled for the study.

Statistical Analysis:

Data will be expressed as mean ± standard error. Mean change in the VAS in between three groups will be analyzed by One way ANOVA, followed by post-hoc test. Repeated measures ANOVA will be used to analyze the change in the VAS over the period of time in between three groups. For comparison of numerical variables between three groups, appropriate parametric tests will be used. Chi-square test or Fischer’s Exact test will be used to compare categorical variables. Intragroup comparison of mean changes in outcomes will be evaluated by Paired t-test. Analysis will be done using SPSS version 21 (IBM Corp. Ltd, Newark, USA).