Angle Class II, Division 1 MalocclusionNCT04743700
"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction
A study testing Piezocision and Micro-osteoperforations in people with Angle Class II, Division 1 Malocclusion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Angle Class II, Division 1 Malocclusion
- What is being tested?
- Piezocision and Micro-osteoperforations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 25 Dec 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
About this study
Official title: "Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction: A Split Mouth Randomized Clinical Trial"
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.
Read the 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
- Conditions
- Angle Class II, Division 1 Malocclusion
- Being tested
- Piezocision, Micro-osteoperforations
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiezocisionProcedure or surgery
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-osteoperforationsProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Micro-osteoperforations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 16th week
Secondary outcomes (4)
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).
Measured: at the beginning of canine retraction
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).
Measured: 24 hours
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).
Measured: 7th day
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).
Measured: 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start25 Dec 2020
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angle Class II, Division 1 MalocclusionStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743700
- Sponsor's protocol ID
- Karan.mahendru
- Status last verified
- Feb 2021
- First submitted
- 14 Dec 2020
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction: A Split Mouth Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT04743700
- Acronym / sponsor ID
- Karan.mahendru
- Conditions
- Angle Class II, Division 1 Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 25 Dec 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezocision on Experimental Side A | Experimental | Procedure: PiezocisionPiezocisions 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 |
| Micro-osteoperforations on Experimental side B | Experimental | Procedure: Micro-osteoperforationsThree 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 |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiezocisionPiezocisions 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. | Procedure or surgery | Piezocision on Experimental Side A |
| Micro-osteoperforationsThree 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 | Procedure or surgery | Micro-osteoperforations on Experimental side B |
Primary outcome
Measurement of rate of canine retraction
Time frame: 4th week
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
Time frame: 8th week
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
Time frame: 12th week
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
Time frame: 16th week
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
4 secondary outcomes
Assessment of pain/discomfort level
Time frame: at the beginning of canine retraction
Assessment of pain/discomfort level
Time frame: 24 hours
Assessment of pain/discomfort level
Time frame: 7th day
Assessment of pain/discomfort level
Time frame: 28th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezocision and Micro-osteoperforations in people with Angle Class II, Division 1 Malocclusion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manisha Kamal Kukreja, MDS (9215650617, mk3pgids@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of rate of canine retraction (time frame: 4th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.