Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment

NCT ID: NCT01720797

Last Updated: 2015-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-04-30

Brief Summary

The purpose of this research study is to assess the clinical effectiveness of the procedure of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth movement in patients undergoing orthodontic treatment. "Accelerated tooth movement" means that using the PROPEL™ device may help complete your treatment with braces on one side of your mouth sooner than would be expected if the device were not to be used.

Detailed Description

Following informed consent and satisfying the screening/enrollment assessments, a panoramic and periapical radiograph of the teeth designated for micro-osteoperforation treatment is to be taken. Prior to the intervention the subjects will swish 5cc of chlorhexidine for one minute, twice. Micro-osteoperforation, PROPEL™, is conducted under local or topical anesthesia AFTER the subject is banded and bonded. The procedure will be randomized to either the left or right side in each subject. Following the procedure, Chlorhexidine rinses are to begin twice a day for a week.

The subjects will be advised to take Tylenol only in case of significant pain. Subjects will be seen four to six weeks after completion of treatment for the first follow-up. Subjects will be followed up with a telephone consult 24 hours after micro-osteoperforation is performed. They will be asked if any pain medication was taken after being dismissed from the research center and if so, they will be asked the name and dose of medication taken.

Study will conclude at the 6 month follow up visit or when space on the treating side is closed.

Conditions

Malocclusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Micro-osteoperforation

Minimally invasive micro-osteoperforation (PROPEL™) procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.

Group Type: EXPERIMENTAL

Micro-osteoperforation

Intervention Type: DEVICE

Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.

Anesthestic

Intervention Type: DRUG

Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.

Chlorhexidine

Intervention Type: OTHER

Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week.

Non Micro-osteoperforation

Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.

Group Type: OTHER

Chlorhexidine

Intervention Type: OTHER

Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week.

Interventions

Micro-osteoperforation

Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.

Intervention Type: DEVICE

Anesthestic

Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.

Intervention Type: DRUG

Chlorhexidine

Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week.

Intervention Type: OTHER

Other Intervention Names

PROPEL™; Topical or local anesthetic; Peridex

Eligibility Criteria

Inclusion Criteria

• Adolescent and adult subjects ages 18-55 years old, in good general health, with adult or mixed dentition, regardless of presence of third molars.
• Subjects are American Society of Anesthesiologists (ASA) class I (ASA class I - Patients are considered to be normal and healthy).
• Periodontal or gingivitis diseases must be addressed prior to study enrollments: Probing Depth(PD)<5mm,Gingival Index (GI)<1,Plaque Index(PI)=1
• If any caries is present, patient will be referred to dentist for treatment and maintenance before beginning treatment
• Able to understand English, follow simple instructions and sign informed consent

Exclusion Criteria

• Subjects who have taken any local or systemic antibiotics, corticosteroids or periodontal medications in the previous six weeks.
• Subjects with extreme skeletal class II malocclusion: Overjet>10mm, (Pogonion to Nasion Perpendicular line)Pg-Nper>18mm, A point Nasion B point (ANB)>7, Sella Nasion line to Gonion Gnathion Line (SN-GoGN)>38
• Vulnerable subjects who unable to consent for themselves

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AlevoLogic LLC

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Calogero Dolce, D.D.S, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida, Interim Chair

Locations

University of Florida, Department of Orthodontics

Gainesville, Florida, United States

Countries

United States

Other Identifiers

20121593

Identifier Type: -

Identifier Source: org_study_id