Clinical trial NCT04940351: Evaluation of the Effectiveness of Piezocision and Micro-osteoperforation in Alleviating Mandibular Anterior Crowding
Official title: Comparative Evaluation of the Effectiveness of Piezocision and Micro-osteoperforation in Alleviating Mandibular Anterior Crowding: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crowding of Anterior Mandibular Teeth
Keywords: dental crowding
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

Patient satisfying the following criteria will be included in this clinical study:

1. Patients with age between 16-25 years
2. 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)
3. Permanent dentition
4. Existence of all tooth in the mandibular arch (except third molars which may or may not be present)
5. Good oral hygiene and periodontal health
6. No smoking habit.

Exclusion Criteria:

1. medical conditions that would affect tooth movement (corticosteroid treatments, NSAIDs consumption, bisphosphonates, hyperparathyroidism, osteoporosis, uncontrolled diabetes)
2. Contraindication to oral surgery (medical, social, psychological)
3. Missing tooth in the mandibular arch
4. Presence of primary or supernumerary tooth in mandibular arch
5. Previous orthodontic treatment
6. Poor oral hygiene and current periodontal disease
7. Smoking habit.

Primary outcomes:
measure: Amount of Crowding Relieved
timeFrame: 4 weeks
measure: Amount of Crowding Relieved
timeFrame: 8 weeks
measure: Amount of Crowding Relieved
timeFrame: 12 weeks
measure: Amount of Crowding Relieved
timeFrame: 16 weeks
Secondary outcomes:
measure: Overall Alignment Time
timeFrame: 16 weeks
measure: Root resorption of mandibular anteriors
timeFrame: 16 weeks
measure: Marginal Alveolar Bone Loss
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
References: