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"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction

Primary Purpose

Angle Class II, Division 1 Malocclusion

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Piezocision
Micro-osteoperforations
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angle Class II, Division 1 Malocclusion

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Presence of any signs and symptoms of gingival and periodontal diseases.
  2. Overjet more than 10mm.
  3. Long-term drug history.
  4. Systemic diseases.
  5. Evidence of bone loss.
  6. Smoking habit.

Sites / Locations

  • Post Graduate Institute of Dental SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Piezocision on Experimental Side A

Micro-osteoperforations on Experimental side B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Assessment of pain/discomfort level
The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).
Assessment of pain/discomfort level
The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).
Assessment of pain/discomfort level
The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).
Assessment of pain/discomfort level
The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).

Full Information

First Posted
December 14, 2020
Last Updated
February 4, 2021
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT04743700
Brief Title
"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction
Official Title
"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction: A Split Mouth Randomized Clinical Trial"
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 25, 2020 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Patients with Angle's Class II division 1 malocclusion meeting selection criteria and are indicated for maxillary first premolar extraction, patients will be referred for extraction of the maxillary first premolars , treatment will be initiated by bonding preadjusted MBT 0.022" slot straight wire appliance(Patient will be instructed to report immediately in case of breakage of appliance), after that, leveling and alignment will be done in all subjects, after insertion of 0.019"× 0.025" stainless steel arch wire, alginate impression and periapical radiograph of canine and first molar region will be taken(Before the initiation of canine retraction), randomisation and allocation of two sides of maxillary arch i.e. right and left will be done and active interventions(piezocision and micro-osteoperforations) for each side will be done, immediately maxillary canine retraction will be started with mini-implant and closed NiTi coil spring, patient will be asked to fill pain and discomfort assessment card immediately after initiation of canine retraction., subsequent impressions records will be taken at 4th, 8th, 12th and 16th weeks for measuring rate of maxillary canine retraction, data collection and interpretation of results, further pain assessment cards will be filled after 24 hours, on 7th day and 28th day

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angle Class II, Division 1 Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Piezocision on Experimental Side A
Arm Type
Experimental
Arm Description
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
Arm Title
Micro-osteoperforations on Experimental side B
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Piezocision
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Micro-osteoperforations
Intervention Description
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
Primary Outcome Measure Information:
Title
Measurement of rate of canine retraction
Description
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
Time Frame
4th week
Title
Measurement of rate of canine retraction
Description
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
Time Frame
8th week
Title
Measurement of rate of canine retraction
Description
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
Time Frame
12th week
Title
Measurement of rate of canine retraction
Description
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
Time Frame
16th week
Secondary Outcome Measure Information:
Title
Assessment of pain/discomfort level
Description
The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).
Time Frame
at the beginning of canine retraction
Title
Assessment of pain/discomfort level
Description
The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).
Time Frame
24 hours
Title
Assessment of pain/discomfort level
Description
The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).
Time Frame
7th day
Title
Assessment of pain/discomfort level
Description
The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).
Time Frame
28th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manisha Kamal Kukreja, MDS
Phone
9215650617
Email
mk3pgids@gmail.com
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction

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