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

Angle Class II, Division 1 Malocclusion Clinical Trial

Official title:

"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction: A Split Mouth Randomized Clinical Trial"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04743700
• Other study ID #: Karan.mahendru
• Status: Recruiting
• Phase: N/A
• Start date: December 25, 2020
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Manisha Kamal Kukreja, MDS
• Phone: 9215650617
• Email: mk3pgids[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angle Class II, Division 1 Malocclusion
• Malocclusion
• Malocclusion, Angle Class II

Intervention

Procedure:
• Piezocision
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.
• Micro-osteoperforations
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

Locations

Country	Name	City	State
India	Post Graduate Institute of Dental Sciences	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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).	at the beginning of canine retraction
Secondary	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).	24 hours
Secondary	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).	7th day
Secondary	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).	28th day