NCT04743700

Brief Summary

Acceleration of orthodontic tooth movement persuades tremendous rise in the interest of adolescents and aduts, as it not only shortens the treatment duration but also lessens the incidence of white spot lesions, root resorption, periodontal and other soft tissue problems. Minimal invasive techniques i.e.both piezocision and micro-osteoperforations had promising results in accelerating tooth movement. Therefore current study will provide evidence for better minimal invasive technique in terms of reducing treatment time and patient comfort.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

December 25, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

December 14, 2020

Last Update Submit

February 4, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Measurement of rate of canine retraction

    Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction

    4th week

  • Measurement of rate of canine retraction

    Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction

    8th week

  • Measurement of rate of canine retraction

    Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction

    12th week

  • Measurement of rate of canine retraction

    Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction

    16th week

Secondary Outcomes (4)

  • Assessment of pain/discomfort level

    at the beginning of canine retraction

  • Assessment of pain/discomfort level

    24 hours

  • Assessment of pain/discomfort level

    7th day

  • Assessment of pain/discomfort level

    28th day

Study Arms (2)

Piezocision on Experimental Side A

EXPERIMENTAL

Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome to accelerate maxillary canine retraction

Procedure: Piezocision

Micro-osteoperforations on Experimental side B

EXPERIMENTAL

Three MOPs with the help of mini-implant screw driver,mesial and distal to canine(in a vertical line) with the help of minisrew implant driver to accelrate maxillary canine retraction

Procedure: Micro-osteoperforations

Interventions

PiezocisionPROCEDURE

Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome. These piezocisions will be performed on the buccal cortical bone only, 2-3mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (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 . The exact location of incision will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added and then 5mm incision is given in gingiva and overlying mucoperiosteum in a vertical line apically to expose the underlying bone.

Piezocision on Experimental Side A

Three MOPs mesial and three MOPs distal to canine(in a vertical line) with the help of minisrew implant driver (fig.2). These MOPs will be performed on the buccal cortical bone only, 2-3 mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and no flap will be raised. The exact location of first MOP will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added. The location of second MOP at 5mm apically in a vertical line and third MOP at 5 mm apically to second MOP

Micro-osteoperforations on Experimental side B

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with age between 16-25 years
  • Patients with Angle's class II division 1 malocclusion requiring bilateral extraction of maxillary first premolars.
  • Overjet of ≤ 10mm
  • No debilitating systemic disease.
  • No radiographic evidence of bone loss.
  • No history of periodontal disease/ therapy.
  • No smoking habit.
  • Probing depth of not more than 3mm in all teeth.

You may not qualify if:

  • Presence of any signs and symptoms of gingival and periodontal diseases.
  • Overjet more than 10mm.
  • Long-term drug history.
  • Systemic diseases.
  • Evidence of bone loss.
  • Smoking habit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Central Study Contacts

Manisha Kamal Kukreja, MDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2020

First Posted

February 8, 2021

Study Start

December 25, 2020

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations