The Effect of Corticotomy in En-mass Retraction
1 other identifier
interventional
26
0 countries
N/A
Brief Summary
- To compare patients who will undergo orthodontics treatment involving upper premolar extraction for space of time whether with or without corticotomy by Piezotome.
- Assess the safety of both methods of retraction in regard to the quality of the surrounding periodontium and roots of anterior teeth.
- Monitor postoperative pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 25, 2016
CompletedFirst Posted
Study publicly available on registry
June 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedOctober 3, 2023
October 1, 2023
1.3 years
December 25, 2016
October 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of tooth movement per time
4 months
Study Arms (2)
Orthodontic tooth movement group
NO INTERVENTIONThis is the control group in which pateints will be treated by conventional orthodontic treatment and extraction of premolars without piezotome
Corticotomy assisted orthodontic group
EXPERIMENTALThis is the study group in which patients will be treated by conventional orthodontic treatment aided by corticotomy procedure perfumed by using a piezotome.(piezotome assisted orthodontic tooth movement)
Interventions
Surgical procedure 1. After local anesthesia, vertical interproximal incisions will be done under the interdental papilla, on the labial aspect of upper arch using a blade No. 15. 2. The incisions will be kept minimal. 3. The incisions go though the periosteum, which permit the blade to reach to the alveolar bone. 4. A Piezo surgical knife will be used to make the cortical alveolar incision through the gingival incisions to a depth of approximately 3mm. 5. As we will not use bone graft so we don't need use suturing after cortication. 6. We give patient antibiotic and analgesic cover.
Eligibility Criteria
You may qualify if:
- On the basis of the diagnosis of the malocclusion, individuals who have Class I and Class II malocclusions and requiring extraction of premolars and retraction of anterior teeth will be selected (maxillary/mandibular or both).
- Good oral hygiene, healthy gingiva and no evidence of bone loss as seen in radiograph.
- Healthy systemic conditions.
- No previous orthodontic treatment.
- Patient needs to be in permanent dentition (hence, we need to define their age range).
You may not qualify if:
- Patient with systemic disease.
- Patient having any signs of active periodontal disease.
- Patients on long-term corticosteroid therapy.
- Persons taking medications that slows down bone metabolism.
- Craniofacial anomalies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hatrom AA, Howait MS, Zawawi KH, Al-Turki GA, Alansari RA, Almehayawi NF, Alammari SH, Mohammed RA, Hassan AH. Pulp volume changes after piezocision-assisted tooth movement: a randomized clinical trial. BMC Oral Health. 2021 Jan 13;21(1):28. doi: 10.1186/s12903-020-01382-2.
PMID: 33435897DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in orthodontic department
Study Record Dates
First Submitted
December 25, 2016
First Posted
June 8, 2017
Study Start
September 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
October 3, 2023
Record last verified: 2023-10