Clinical trial NCT04743700: "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
Overall status: UNKNOWN
Phase: NA
Conditions: Angle Class II, Division 1 Malocclusion
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of rate of canine retraction
timeFrame: 4th week
measure: Measurement of rate of canine retraction
timeFrame: 8th week
measure: Measurement of rate of canine retraction
timeFrame: 12th week
measure: Measurement of rate of canine retraction
timeFrame: 16th week
Secondary outcomes:
measure: Assessment of pain/discomfort level
timeFrame: at the beginning of canine retraction
measure: Assessment of pain/discomfort level
timeFrame: 24 hours
measure: Assessment of pain/discomfort level
timeFrame: 7th day
measure: Assessment of pain/discomfort level
timeFrame: 28th day
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
References: