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

NCT04940351 | Unknown DMC

• 1 other identifier: ANANDA RAJ S PGIDS/BHRC/21/19
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crowding of Anterior Mandibular Teeth

Keywords

dental crowding

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Overall Alignment Time

  16 weeks

• Root resorption of mandibular anteriors

  16 weeks

• Marginal Alveolar Bone Loss

  16 weeks

Study Arms (2)

GROUP - A: PIEZOCISION GROUP

EXPERIMENTAL

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

GROUP- B: MICRO-OSTEOPERFORATION GROUP

EXPERIMENTAL

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

Interventions

GROUP - A: PIEZOCISION GROUP PROCEDURE

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.

GROUP - A: PIEZOCISION GROUP

GROUP- B: MICRO-OSTEOPERFORATION GROUP PROCEDURE

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.

GROUP- B: MICRO-OSTEOPERFORATION GROUP

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient satisfying the following criteria will be included in this clinical study:
• Patients with age between 16-25 years
• 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)
• Permanent dentition
• Existence of all tooth in the mandibular arch (except third molars which may or may not be present)
• Good oral hygiene and periodontal health
• No smoking habit.

You may not qualify if:

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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Central Study Contacts

MANISHA KAMAL KUKREJA, MDS

CONTACT

9215650617; mk3pgids@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: June 15, 2021
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)