Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment

NCT01720797 | Completed Results DMC

• 1 other identifier: 20121593
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion

Keywords

Malocclusion; Accelerated tooth movement; Braces; Orthodontic treatment; Propel

Outcome Measures

Primary Outcomes (1)

• Tooth Movement Between the Groups

  Accelerated tooth movement effectiveness as measured by dental impressions. These impressions at the 6 month follow-up will evaluate the rate of tooth movement by measuring casts. Ortholnsight software was used to measure the millimeters of tooth movement from the dental impressions, and then was converted to a Mean and Standard Deviation measurement.

  6 months

Study Arms (2)

Micro-osteoperforation

EXPERIMENTAL

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.

Device: Micro-osteoperforation; Drug: Anesthestic; Other: Chlorhexidine

Non Micro-osteoperforation

OTHER

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.

Other: Chlorhexidine

Interventions

Micro-osteoperforation DEVICE

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

Also known as: PROPEL™

Micro-osteoperforation

Anesthestic DRUG

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

Also known as: Topical or local anesthetic

Micro-osteoperforation

Chlorhexidine 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.

Also known as: Peridex

Micro-osteoperforation; Non Micro-osteoperforation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• AlevoLogic LLC: collaborator

Study Sites (1)

University of Florida, Department of Orthodontics

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Malocclusion

Interventions

Anesthetics, Local; Chlorhexidine; chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Calogero Dolce, DDS, PhD
• Organization: University of Florida

cdolce@dental.ufl.edu

352-273-5700

Study Officials

• Calogero Dolce, D.D.S, PhD

  University of Florida, Interim Chair

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 2, 2012
• Study Start: February 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 19, 2015
• Results First Posted: June 19, 2015

Record last verified: 2015-06

Locations

US (1)