Antibiotics Prior to Mini-screw Implant Insertion

NCT03582605 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 29379
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to use amoxicillin in capsule form, prepared by a pharmacist, for antibiotic prophylaxis to decrease the failure rate of mini-screw implants temporarily placed in the palate of patients involved in Phase II orthodontics treatments. The mini-screws will be 8 mm long 1.7 mm diameter titanium screws manufactured by Forestadent and are commercially available and currently widely used in orthodontic treatment in both private practice and educational settings. Since antibiotic prophylaxis is considered the standard of care with traditional dental implants, the investigators believe that such prophylaxis will decrease the failure rate of orthodontic mini-screw implants also.

Conditions

Inflammation at Mini-screw Insertion Site; Mobility, Mini-screw

Keywords

antibiotics; prophylaxis; temporary anchorage devices; mini-screw implants; TADs; MSIs; failure rate

Outcome Measures

Primary Outcomes (4)

• Mini-screw implant success or failure

  Participants will undergo an intra-oral exam to determine mobility of the mini-screw(s), to check for inflammation at the site of mini-screw placement. Mobility will be determined by placing a small amount of force on the mini-screw with a cotton plier. The amount of mobility will be assessed as having no mobility (Grade 0), having between 0mm and 1 mm of mobility (Grade 1), or having more than 1 mm of mobility (Grade 2). Inflammation will be assessed as having no redness or swelling at the site (Grade 0), having redness only at the site (Grade 1), or having both redness and swelling (Grade 2). Success of the mini-screw will be defined as number of survival with "Mobility Grade 0 or 1" \& "No Pain" \& "Inflammation Grade 0 or 1". Failure of the mini-screw will be immediately determined as failed if the mini-screw is not present at one of the time points or upon an assessment of Grade 2 mobility. Grade 2 mobility will result in removal of the mini-screw.

  T(0) at time of insertion

• Mini-screw implant success or failure

  Participants will undergo an intra-oral exam to determine mobility of the mini-screw(s), to check for inflammation at the site of mini-screw placement. Mobility will be determined by placing a small amount of force on the mini-screw with a cotton plier. The amount of mobility will be assessed as having no mobility (Grade 0), having between 0mm and 1 mm of mobility (Grade 1), or having more than 1 mm of mobility (Grade 2). Inflammation will be assessed as having no redness or swelling at the site (Grade 0), having redness only at the site (Grade 1), or having both redness and swelling (Grade 2). Success of the mini-screw will be defined as number of survival with "Mobility Grade 0 or 1" \& "No Pain" \& "Inflammation Grade 0 or 1". Failure of the mini-screw will be immediately determined as failed if the mini-screw is not present at one of the time points or upon an assessment of Grade 2 mobility. Grade 2 mobility will result in removal of the mini-screw.

  T(1) at 1 month post-placement

• Mini-screw implant success or failure

  Participants will undergo an intra-oral exam to determine mobility of the mini-screw(s), to check for inflammation at the site of mini-screw placement. Mobility will be determined by placing a small amount of force on the mini-screw with a cotton plier. The amount of mobility will be assessed as having no mobility (Grade 0), having between 0mm and 1 mm of mobility (Grade 1), or having more than 1 mm of mobility (Grade 2). Inflammation will be assessed as having no redness or swelling at the site (Grade 0), having redness only at the site (Grade 1), or having both redness and swelling (Grade 2). Success of the mini-screw will be defined as number of survival with "Mobility Grade 0 or 1" \& "No Pain" \& "Inflammation Grade 0 or 1". Failure of the mini-screw will be immediately determined as failed if the mini-screw is not present at one of the time points or upon an assessment of Grade 2 mobility. Grade 2 mobility will result in removal of the mini-screw.

  T(2) at 3 months post-placement

• Mini-screw implant success or failure

  Participants will undergo an intra-oral exam to determine mobility of the mini-screw(s), to check for inflammation at the site of mini-screw placement. Mobility will be determined by placing a small amount of force on the mini-screw with a cotton plier. The amount of mobility will be assessed as having no mobility (Grade 0), having between 0mm and 1 mm of mobility (Grade 1), or having more than 1 mm of mobility (Grade 2). Inflammation will be assessed as having no redness or swelling at the site (Grade 0), having redness only at the site (Grade 1), or having both redness and swelling (Grade 2). Success of the mini-screw will be defined as number of survival with "Mobility Grade 0 or 1" \& "No Pain" \& "Inflammation Grade 0 or 1". Failure of the mini-screw will be immediately determined as failed if the mini-screw is not present at one of the time points or upon an assessment of Grade 2 mobility. Grade 2 mobility will result in removal of the mini-screw.

  T(3) at 6 months post-placement

Study Arms (2)

Control Group

PLACEBO COMPARATOR

All participants will be weighed. This group will receive a placebo (glucose) 1 hour prior to insertion of mini-screw implants.

Drug: Placebo oral capsule

Experimental Group

EXPERIMENTAL

All participants will be weighed so that appropriate dosing can be ensured and will receive 2 grams of Amoxicillin 1 hour prior to mini-screw insertion. Patients weighing less than 40 kg will be given 50mg/kg of Amoxicillin.

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

see previous descriptions

Experimental Group

Placebo oral capsule DRUG

see previous descriptions

Control Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with experience in previous MSI placements
• allergy to amoxicillin
• allergy to Beta-lactam based antibiotics
• medical syndrome diagnoses
• psychiatric disorders (ADHD, autism, manic-depressive disorder, etc.)
• a compromised immune system
• impaired or decreased kidney function
• Type I or Type II diabetes
• patients taking Probenicid or Allopurinol

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University Center for Advanced Dental Education

St Louis, Missouri, 63104, United States

Location

Related Publications (24)

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  BACKGROUND

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  BACKGROUND

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• Esposito M, Grusovin MG, Worthington HV. Interventions for replacing missing teeth: antibiotics at dental implant placement to prevent complications. Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD004152. doi: 10.1002/14651858.CD004152.pub4.

  PMID: 23904048 BACKGROUND

• Esposito M, Hirsch JM, Lekholm U, Thomsen P. Biological factors contributing to failures of osseointegrated oral implants. (II). Etiopathogenesis. Eur J Oral Sci. 1998 Jun;106(3):721-64. doi: 10.1046/j.0909-8836..t01-6-.x.

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  BACKGROUND

• Freudenthaler JW, Haas R, Bantleon HP. Bicortical titanium screws for critical orthodontic anchorage in the mandible: a preliminary report on clinical applications. Clin Oral Implants Res. 2001 Aug;12(4):358-63. doi: 10.1034/j.1600-0501.2001.012004358.x. English, French, German.

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• Lee SJ, Ahn SJ, Lee JW, Kim SH, Kim TW. Survival analysis of orthodontic mini-implants. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):194-9. doi: 10.1016/j.ajodo.2008.03.031.

  PMID: 20152674 BACKGROUND

• Miyawaki S, Koyama I, Inoue M, Mishima K, Sugahara T, Takano-Yamamoto T. Factors associated with the stability of titanium screws placed in the posterior region for orthodontic anchorage. Am J Orthod Dentofacial Orthop. 2003 Oct;124(4):373-8. doi: 10.1016/s0889-5406(03)00565-1.

  PMID: 14560266 BACKGROUND

• Odman J, Lekholm U, Jemt T, Branemark PI, Thilander B. Osseointegrated titanium implants--a new approach in orthodontic treatment. Eur J Orthod. 1988 May;10(2):98-105. doi: 10.1093/ejo/10.2.98. No abstract available.

  PMID: 3164683 BACKGROUND

• Ohmae M, Saito S, Morohashi T, Seki K, Qu H, Kanomi R, Yamasaki KI, Okano T, Yamada S, Shibasaki Y. A clinical and histological evaluation of titanium mini-implants as anchors for orthodontic intrusion in the beagle dog. Am J Orthod Dentofacial Orthop. 2001 May;119(5):489-97. doi: 10.1067/mod.2001.114300.

  PMID: 11343020 BACKGROUND

• Papadopoulos MA, Tarawneh F. The use of miniscrew implants for temporary skeletal anchorage in orthodontics: a comprehensive review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e6-15. doi: 10.1016/j.tripleo.2006.11.022. Epub 2007 Feb 21.

  PMID: 17317235 BACKGROUND

• Prophylaxis in surgery. Veterans Administration Ad Hoc Interdisciplinary Advisory Committee on Antimicrobial Drug Usage. JAMA. 1977 Mar 7;237(10):1003-8. No abstract available.

  PMID: 319261 BACKGROUND

• Reynders R, Ronchi L, Bipat S. Mini-implants in orthodontics: a systematic review of the literature. Am J Orthod Dentofacial Orthop. 2009 May;135(5):564.e1-19; discussion 564-5. doi: 10.1016/j.ajodo.2008.09.026.

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• Roberts WE, Helm FR, Marshall KJ, Gongloff RK. Rigid endosseous implants for orthodontic and orthopedic anchorage. Angle Orthod. 1989 Winter;59(4):247-56. doi: 10.1043/0003-3219(1989)0592.0.CO;2.

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• Roberts WE, Marshall KJ, Mozsary PG. Rigid endosseous implant utilized as anchorage to protract molars and close an atrophic extraction site. Angle Orthod. 1990 Summer;60(2):135-52. doi: 10.1043/0003-3219(1990)0602.0.CO;2.

  PMID: 2344070 BACKGROUND

• Roberts WE, Smith RK, Zilberman Y, Mozsary PG, Smith RS. Osseous adaptation to continuous loading of rigid endosseous implants. Am J Orthod. 1984 Aug;86(2):95-111. doi: 10.1016/0002-9416(84)90301-4.

  PMID: 6589962 BACKGROUND

• Sharaf B, Jandali-Rifai M, Susarla SM, Dodson TB. Do perioperative antibiotics decrease implant failure? J Oral Maxillofac Surg. 2011 Sep;69(9):2345-50. doi: 10.1016/j.joms.2011.02.095. Epub 2011 Jun 15.

  PMID: 21676512 BACKGROUND

• Wehrbein H, Merz BR. Aspects of the use of endosseous palatal implants in orthodontic therapy. J Esthet Dent. 1998;10(6):315-24. doi: 10.1111/j.1708-8240.1998.tb00510.x.

  PMID: 10321202 BACKGROUND

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hiroshi Ueno, DDS

  Full time faculty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The Amoxicillin and the placebo (glucose) will be prepared in capsule form by a pharmacist and made to look identical.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Saint Louis University Orthodontic Resident

Model Details: The study will be a double-blind randomized control trial in which half the participants will be given two grams of amoxicillin in capsule form, prepared by a pharmacist, and the other half will be given a placebo in capsule form, prepared by a pharmacist, 1 hour prior to MSI placement. Sealed envelopes containing either antibiotics or placebo capsules will be given to patients, with only the research committee chair knowing which patients are in the control group (placebo) and which are in the experimental group (antibiotics). Test subjects will be followed for 1 month (T1), 3 months (T2), 6 months (T3) following placement of MSIs.

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 11, 2018
• Study Start: August 7, 2018
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)