Evaluation of the Effectiveness of Piezocision and Micro-osteoperforation in Alleviating Mandibular Anterior Crowding

Comparative Evaluation of the Effectiveness of Piezocision and Micro-osteoperforation in Alleviating Mandibular Anterior Crowding: A Randomized Clinical Trial

In recent times, many patients want their treatment duration to be reduced, because lengthy orthodontic treatment duration is associated with negative sequelae such as discomfort, pain, white spot lesions, and decreased patient's compliance. Several techniques have been employed in an attempt to accelerate the tooth movement and shorten the lengthy orthodontic treatment duration. So, this study will investigate the effectiveness of minimal invasive technique like piezocision and microosteoperforation in alleviating mandibular anterior crowding which is one of the common malocclusiom and provide scientific knowledge regarding which minimal invasive tecnique will relieve the crowding faster.

Study Overview

• Status: Recruiting
• Conditions: Crowding of Anterior Mandibular Teeth
• Intervention / Treatment: Procedure: GROUP - A: PIEZOCISION GROUP; Procedure: GROUP- B: MICRO-OSTEOPERFORATION GROUP

Detailed Description

Records will be taken from patients who are meeting selection criteria and then analysis of record will be done to attain a proper diagnosis and treatment plan. Afterthat, those patients will be referred to oral surgery department for extraction of first premolar. After healing, orthodontic treatment will be started with bonding of preadjusted MBT 0.022" slot straight wire appliance(Patient will be instructed to report immediately in case of breakage of appliance), after that, randomisation and allocation of two groups will be done and on the day of initial aligning archwire placement i.e., 0.014" NiTi, active interventions(piezocision and micro-osteoperforations) will be done for each group and then levelling and alignment will be continued with the following arch wire sequence 0.016" , 0.016" x 0.022" and 0.017" x 0.025" NiTi. Levelling and alignment will be considered finished when 0.017x0.025" NiTi archwire will be engaged passively in the brackets. Records i.e,. mandibular study models will be taken on the day of surgical procedure before surgery (T0) and then after every 4th week i.e., 4th week(T1), 8th week(T2), 12th week(T3), 16th week(T4). Following this, data collection and interpretation of results will be done. And also, CBCT will be taken at post levelling and alignment with 0.017" x 0.025" arch wire to assess the root resorption and marginal alveolar bone loss.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MANISHA KAMAL KUKREJA, MDS; Phone Number: 9215650617; Email: mk3pgids@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • Post Graduate Institute of dental sciences
      • Contact: MANISHA KAMAL KUKREJA, MDS; Phone Number: 9215650617; Email: mk3pgids@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patient satisfying the following criteria will be included in this clinical study:

1. Patients with age between 16-25 years
2. Patients with either Angle's class I or class II malocclusion with moderate crowding in the anterior mandible(LII- 4-6mm) who requires extraction in the lower arch (tooth-size-arch-length discrepancy>5 mm)
3. Permanent dentition
4. Existence of all tooth in the mandibular arch (except third molars which may or may not be present)
5. Good oral hygiene and periodontal health
6. No smoking habit.

Exclusion Criteria:

1. medical conditions that would affect tooth movement (corticosteroid treatments, NSAIDs consumption, bisphosphonates, hyperparathyroidism, osteoporosis, uncontrolled diabetes)
2. Contraindication to oral surgery (medical, social, psychological)
3. Missing tooth in the mandibular arch
4. Presence of primary or supernumerary tooth in mandibular arch
5. Previous orthodontic treatment
6. Poor oral hygiene and current periodontal disease
7. Smoking habit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GROUP - A: PIEZOCISION GROUP; This group will receive piezocision using piezotome inbetween the roots of mandibular anteriors after the placement of initial arch wire.	Procedure: GROUP - A: PIEZOCISION GROUP; This group will receive piezocisions after placement of initial arch wire, in between the roots of mandibular anteriors (in a vertical line) i.e., between mandibular canine and lateral incisors bilaterally, lateral incisors and central incisors bilaterally and between two cental incisors with the help of piezotome. These piezocisions will be performed on the labial cortical bone only, 4mm below the interdental papilla under 2% lidocaine with 1:100,000 epinephrine and with standard asepsis, and gingival overlying will be incised first with blade number 15 in a Bard Parker handle. A piezosurgical microsaw with piezosurgical drill will be placed over that incision with irrigation. Then, vertical 5- to 8-mm and 3mm deep corticotomies will be perform using periapical radiographs as a guide to avoid penetrating into the adjacent roots. No subsequent sutures required.
Experimental: GROUP- B: MICRO-OSTEOPERFORATION GROUP; This group will receive Micro-Osteoperforation using orthodontic mini-implants and mini-implant screw driver after the placement of initial arch wire.	Procedure: GROUP- B: MICRO-OSTEOPERFORATION GROUP; This group will receive MOPs after initial arch wire placement. These MOPs will be performed under local anesthesia with standard asepsis, using a self drilling 1.6mm x 8mm orthodontic mini-implants and mini-implant screw driver and no flap will be raised. MOP's will be placed on five sites i.e., interproximally between mandibular canine and lateral incisors bilaterally, central incisor and lateral incisor bilaterally and between two central incisors. Each site will receive two MOP's, first 2mm apical to alveolar crest and second 2mm below the first in a vertical line and 2mm deep into the bone. Then the mini-implant will be removed by rotating the screw driver anticlockwise and pressure will be applied to achieve hemostasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Crowding Relieved	Measured with Little Irregularity index using Digital caliper	4 weeks
Amount of Crowding Relieved	Measured with Little Irregularity index using Digital caliper	8 weeks
Amount of Crowding Relieved	Measured with Little Irregularity index using Digital caliper	12 weeks
Amount of Crowding Relieved	Measured with Little Irregularity index using Digital caliper	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Alignment Time	Time taken to align the mandibular anteriors calculated in days	16 weeks
Root resorption of mandibular anteriors	Root length of mandibular anteriors measured before and after alignment using CBCT	16 weeks
Marginal Alveolar Bone Loss	Alveolar bone length measured before and after alignment using CBCT	16 weeks

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 9, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: dental crowding
• Other Study ID Numbers: ANANDA RAJ S PGIDS/BHRC/21/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No