Crowding of Anterior Mandibular TeethNCT04940351
Evaluation of the Effectiveness of Piezocision and Micro-osteoperforation in Alleviating Mandibular Anterior Crowding
A study testing GROUP - A: PIEZOCISION GROUP and GROUP- B: MICRO-OSTEOPERFORATION GROUP in people with Crowding of Anterior Mandibular Teeth, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
In recent times, many patients want their treatment duration to be reduced, because lengthy orthodontic treatment duration is associated with negative sequelae such as discomfort, pain, white spot lesions, and decreased patient's compliance. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Crowding of Anterior Mandibular Teeth
- What is being tested?
- GROUP - A: PIEZOCISION GROUP and GROUP- B: MICRO-OSTEOPERFORATION GROUP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jun 2021to Jul 2022
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient satisfying the following criteria will be included in this clinical study:
- Patients with age between 16-25 years
- Patients with either Angle's class I or class II malocclusion with moderate crowding in the anterior mandible(LII- 4-6mm) who requires extraction in the lower arch (tooth-size-arch-length discrepancy>5 mm)
- Permanent dentition
- Existence of all tooth in the mandibular arch (except third molars which may or may not be present)
- Good oral hygiene and periodontal health
- No smoking habit.
Who cannot join
- medical conditions that would affect tooth movement (corticosteroid treatments, NSAIDs consumption, bisphosphonates, hyperparathyroidism, osteoporosis, uncontrolled diabetes)
- Contraindication to oral surgery (medical, social, psychological)
- Missing tooth in the mandibular arch
- Presence of primary or supernumerary tooth in mandibular arch
- Previous orthodontic treatment
- Poor oral hygiene and current periodontal disease
- 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
MANISHA KAMAL KUKREJA, MDS, 9215650617, mk3pgids@gmail.com
About this study
Official title: Comparative Evaluation of the Effectiveness of Piezocision and Micro-osteoperforation in Alleviating Mandibular Anterior Crowding: A Randomized Clinical Trial
In recent times, many patients want their treatment duration to be reduced, because lengthy orthodontic treatment duration is associated with negative sequelae such as discomfort, pain, white spot lesions, and decreased patient's compliance. Several techniques have been employed in an attempt to accelerate the tooth movement and shorten the lengthy orthodontic treatment duration. So, this study will investigate the effectiveness of minimal invasive technique like piezocision and microosteoperforation in alleviating mandibular anterior crowding which is one of the common malocclusiom and provide scientific knowledge regarding which minimal invasive tecnique will relieve the crowding faster.
Read the detailed description
Records will be taken from patients who are meeting selection criteria and then analysis of record will be done to attain a proper diagnosis and treatment plan. Afterthat, those patients will be referred to oral surgery department for extraction of first premolar. After healing, orthodontic treatment will be started with bonding of preadjusted MBT 0.022" slot straight wire appliance(Patient will be instructed to report immediately in case of breakage of appliance), after that, randomisation and allocation of two groups will be done and on the day of initial aligning archwire placement i.e., 0.014" NiTi, active interventions(piezocision and micro-osteoperforations) will be done for each group and then levelling and alignment will be continued with the following arch wire sequence 0.016" , 0.016" x 0.022" and 0.017" x 0.025" NiTi. Levelling and alignment will be considered finished when 0.017x0.025" NiTi archwire will be engaged passively in the brackets. Records i.e,. mandibular study models will be taken on the day of surgical procedure before surgery (T0) and then after every 4th week i.e., 4th week(T1), 8th week(T2), 12th week(T3), 16th week(T4). Following this, data collection and interpretation of results will be done. And also, CBCT will be taken at post levelling and alignment with 0.017" x 0.025" arch wire to assess the root resorption and marginal alveolar bone loss.
- Conditions
- Crowding of Anterior Mandibular Teeth
- Being tested
- GROUP - A: PIEZOCISION GROUP, GROUP- B: MICRO-OSTEOPERFORATION GROUP
- Keywords
- dental crowding
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GROUP - A: PIEZOCISION GROUPProcedure or surgery
This group will receive piezocisions after placement of initial arch wire, in between the roots of mandibular anteriors (in a vertical line) i.e., between mandibular canine and lateral incisors bilaterally, lateral incisors and central incisors bilaterally and between two cental incisors with the help of piezotome. These piezocisions will be performed on the labial cortical bone only, 4mm below the interdental papilla under 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. A piezosurgical microsaw with piezosurgical drill will be placed over that incision with irrigation. Then, vertical 5- to 8-mm and 3mm deep corticotomies will be perform using periapical radiographs as a guide to avoid penetrating into the adjacent roots. No subsequent sutures required.
GROUP- B: MICRO-OSTEOPERFORATION GROUPProcedure or surgery
This group will receive MOPs after initial arch wire placement. These MOPs will be performed under local anesthesia with standard asepsis, using a self drilling 1.6mm x 8mm orthodontic mini-implants and mini-implant screw driver and no flap will be raised. MOP's will be placed on five sites i.e., interproximally between mandibular canine and lateral incisors bilaterally, central incisor and lateral incisor bilaterally and between two central incisors. Each site will receive two MOP's, first 2mm apical to alveolar crest and second 2mm below the first in a vertical line and 2mm deep into the bone. Then the mini-implant will be removed by rotating the screw driver anticlockwise and pressure will be applied to achieve hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| GROUP - A: PIEZOCISION GROUP | Experimental | This group will receive piezocision using piezotome inbetween the roots of mandibular anteriors after the placement of initial arch wire. Receives: Procedure: GROUP - A: PIEZOCISION GROUP |
| GROUP- B: MICRO-OSTEOPERFORATION GROUP | Experimental | This group will receive Micro-Osteoperforation using orthodontic mini-implants and mini-implant screw driver after the placement of initial arch wire. Receives: Procedure: GROUP- B: MICRO-OSTEOPERFORATION GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Crowding Relieved
Measured with Little Irregularity index using Digital caliper
Measured: 4 weeks
Amount of Crowding Relieved
Measured with Little Irregularity index using Digital caliper
Measured: 8 weeks
Amount of Crowding Relieved
Measured with Little Irregularity index using Digital caliper
Measured: 12 weeks
Amount of Crowding Relieved
Measured with Little Irregularity index using Digital caliper
Measured: 16 weeks
Secondary outcomes (3)
Overall Alignment Time
Time taken to align the mandibular anteriors calculated in days
Measured: 16 weeks
Root resorption of mandibular anteriors
Root length of mandibular anteriors measured before and after alignment using CBCT
Measured: 16 weeks
Marginal Alveolar Bone Loss
Alveolar bone length measured before and after alignment using CBCT
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start15 Jun 2021
- Primary completionApr 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crowding of Anterior Mandibular TeethStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 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
- NCT04940351
- Sponsor's protocol ID
- ANANDA RAJ S PGIDS/BHRC/21/19
- Status last verified
- Jan 2022
- First submitted
- 17 Jun 2021
- Last updated
- 25 Jan 2022
- 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 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Effectiveness of Piezocision and Micro-osteoperforation in Alleviating Mandibular Anterior Crowding: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04940351
- Acronym / sponsor ID
- ANANDA RAJ S PGIDS/BHRC/21/19
- Conditions
- Crowding of Anterior Mandibular Teeth
- Keywords
- dental crowding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 25 Jun 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.
In recent times, many patients want their treatment duration to be reduced, because lengthy orthodontic treatment duration is associated with negative sequelae such as discomfort, pain, white spot lesions, and decreased patient's compliance. Several techniques have been employed in an attempt to accelerate the tooth movement and shorten the lengthy orthodontic treatment duration. So, this study will investigate the effectiveness of minimal invasive technique like piezocision and microosteoperforation in alleviating mandibular anterior crowding which is one of the common malocclusiom and provide scientific knowledge regarding which minimal invasive tecnique will relieve the crowding faster.
Detailed description
Records will be taken from patients who are meeting selection criteria and then analysis of record will be done to attain a proper diagnosis and treatment plan. Afterthat, those patients will be referred to oral surgery department for extraction of first premolar. After healing, orthodontic treatment will be started with bonding of preadjusted MBT 0.022" slot straight wire appliance(Patient will be instructed to report immediately in case of breakage of appliance), after that, randomisation and allocation of two groups will be done and on the day of initial aligning archwire placement i.e., 0.014" NiTi, active interventions(piezocision and micro-osteoperforations) will be done for each group and then levelling and alignment will be continued with the following arch wire sequence 0.016" , 0.016" x 0.022" and 0.017" x 0.025" NiTi. Levelling and alignment will be considered finished when 0.017x0.025" NiTi archwire will be engaged passively in the brackets. Records i.e,. mandibular study models will be taken on the day of surgical procedure before surgery (T0) and then after every 4th week i.e., 4th week(T1), 8th week(T2), 12th week(T3), 16th week(T4). Following this, data collection and interpretation of results will be done. And also, CBCT will be taken at post levelling and alignment with 0.017" x 0.025" arch wire to assess the root resorption and marginal alveolar bone loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP - A: PIEZOCISION GROUP | Experimental | Procedure: GROUP - A: PIEZOCISION GROUPThis group will receive piezocision using piezotome inbetween the roots of mandibular anteriors after the placement of initial arch wire. |
| GROUP- B: MICRO-OSTEOPERFORATION GROUP | Experimental | Procedure: GROUP- B: MICRO-OSTEOPERFORATION GROUPThis group will receive Micro-Osteoperforation using orthodontic mini-implants and mini-implant screw driver after the placement of initial arch wire. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patients with age between 16-25 years
- Patients with either Angle's class I or class II malocclusion with moderate crowding in the anterior mandible(LII- 4-6mm) who requires extraction in the lower arch (tooth-size-arch-length discrepancy>5 mm)
- Permanent dentition
- Existence of all tooth in the mandibular arch (except third molars which may or may not be present)
- Good oral hygiene and periodontal health
Key exclusion criteria (7 listed)
- medical conditions that would affect tooth movement (corticosteroid treatments, NSAIDs consumption, bisphosphonates, hyperparathyroidism, osteoporosis, uncontrolled diabetes)
- Contraindication to oral surgery (medical, social, psychological)
- Missing tooth in the mandibular arch
- Presence of primary or supernumerary tooth in mandibular arch
- Previous orthodontic treatment
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 |
|---|---|---|
| GROUP - A: PIEZOCISION GROUPThis group will receive piezocisions after placement of initial arch wire, in between the roots of mandibular anteriors (in a vertical line) i.e., between mandibular canine and lateral incisors bilaterally, lateral incisors and central incisors bilaterally and between two cental incisors with the help of piezotome. These piezocisions will be performed on the labial cortical bone only, 4mm below the interdental papilla under 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. A piezosurgical microsaw with piezosurgical drill will be placed over that incision with irrigation. Then, vertical 5- to 8-mm and 3mm deep corticotomies will be perform using periapical radiographs as a guide to avoid penetrating into the adjacent roots. No subsequent sutures required. | Procedure or surgery | GROUP - A: PIEZOCISION GROUP |
| GROUP- B: MICRO-OSTEOPERFORATION GROUPThis group will receive MOPs after initial arch wire placement. These MOPs will be performed under local anesthesia with standard asepsis, using a self drilling 1.6mm x 8mm orthodontic mini-implants and mini-implant screw driver and no flap will be raised. MOP's will be placed on five sites i.e., interproximally between mandibular canine and lateral incisors bilaterally, central incisor and lateral incisor bilaterally and between two central incisors. Each site will receive two MOP's, first 2mm apical to alveolar crest and second 2mm below the first in a vertical line and 2mm deep into the bone. Then the mini-implant will be removed by rotating the screw driver anticlockwise and pressure will be applied to achieve hemostasis. | Procedure or surgery | GROUP- B: MICRO-OSTEOPERFORATION GROUP |
Primary outcome
Amount of Crowding Relieved
Time frame: 4 weeks
Measured with Little Irregularity index using Digital caliper
Amount of Crowding Relieved
Time frame: 8 weeks
Measured with Little Irregularity index using Digital caliper
Amount of Crowding Relieved
Time frame: 12 weeks
Measured with Little Irregularity index using Digital caliper
Amount of Crowding Relieved
Time frame: 16 weeks
Measured with Little Irregularity index using Digital caliper
3 secondary outcomes
Overall Alignment Time
Time frame: 16 weeks
Root resorption of mandibular anteriors
Time frame: 16 weeks
Marginal Alveolar Bone Loss
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- 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 GROUP - A: PIEZOCISION GROUP and GROUP- B: MICRO-OSTEOPERFORATION GROUP in people with Crowding of Anterior Mandibular Teeth, 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 7 inclusion and 7 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 25 Jan 2022. 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?
Amount of Crowding Relieved (time frame: 4 weeks). 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 25 Jan 2022.