Inflammation at Mini-screw Insertion SiteEarly Phase 1NCT03582605
Antibiotics Prior to Mini-screw Implant Insertion
A Early Phase 1 study testing Amoxicillin in people with Inflammation at Mini-screw Insertion Site and Mobility, Mini-screw, run by St. Louis University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Inflammation at Mini-screw Insertion Site, Mobility, Mini-screw
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 1 Nov 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- impaired or decreased kidney function
- Type I or Type II diabetes
- patients taking Probenicid or Allopurinol
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Louis University Center for Advanced Dental Education
St Louis, Missouri, 63104
About this study
Official title: Antibiotic Prophylaxis Prior to the Insertion of Orthodontic Mini-screw Implants: a Randomized Controlled Trial
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.
Read the detailed description
Subjects will be selected for the study based on treatment plans for Phase II orthodontics at Saint Louis University Center for Advanced Dental Education orthodontics program, which require the use of palatally placed mini-screw implants for anchorage control. If the patient is at or beyond the age of 18 years, they will be approached about this study. If the patient is under the age of 18 years, the parent or legal guardian of the patient will be approached. After the consult is completed, where the treatment plan has been explained and standard consent forms have been signed, a member of the research team will verbally confirm with the patient or the patient and parent/guardian that the patient cannot be excluded from the study based on exclusion criteria from the patient's medical history. Orthodontic treatment at SLU CADE involves monthly visits to the orthodontic clinic where patients receive orthodontic treatment, including leveling and aligning of teeth with archwires and fixed appliances on teeth, space closure, occlusion correction, and finishing and detailing. Mini-screw placement is not necessary nor included in all treatment plans given at SLU CADE orthodontics. The possible subjects for the study will patients who will receive mini-screw implants as a course of their treatment for orthodontic anchorage (standard of care).
Participants will be weighed so that appropriate dosing can be ensured and randomized 1:1 to receive either and antibiotic (Amoxicillin) or a placebo (glucose) 1 hour prior to mini-screw insertion (research related). Patients weighing less than 40 kg will be given 50mg/kg. The Amoxicillin and the placebo (glucose) will be prepared in capsule form by a pharmacist and made to look identical. The Amoxicillin or placebo will be dispensed at CADE and taken at CADE 1 hour prior to the procedure. Standard procedure for dispensing Amoxicillin at SLU CADE is to draw appropriate dosage from the dispensary and provide Amoxicillin to at risk patients prior to invasive dental procedures, in accordance with prophylaxis guidelines set form by the American Heart Association. Documentation of dosage and time of dispensing is noted in the patient record. However, in this study, documentation in the patient dental record will only reflect that either a placebo or Amoxicillin was given as part of a randomized controlled trial. Standard of care for orthodontic mini-screw implants includes oral hygiene instructions and 1 week of oral antibiotic mouth rinse use (.12% Chlorhexidine) and all participants in this study will follow standard of care in addition to the administration of either placebo or antibiotic. Randomization between control or experimental group will be conducted by the Research Chair, Hiroshi Ueno, and the PI will have no knowledge of to which group subjects are assigned.
Participants will be followed at time of mini-screw placement (T0), 1 month post procedure (T1), 3 months post-procedure (T2), and 6 months post-procedure (T3). The participant has standard of care appointments at these time points, so there are not any extra visits for research purposes. At these appointment, 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, assess oral hygiene at the site of mini-screw placement, and be asked to rate both their pain and tenderness related to the mini-screw. Pain is defined as spontaneous pain frim the mini-screw site. Tenderness is defined as pain resulting from palpation of the mini-screw. 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). Oral hygiene will be assessed as having no visible plaque at the site (Grade 0), having small amounts of plaque at the site (Grade 1), or having moderate to large amounts of plaque at the site (Grade 2). Pain and tenderness will be evaluated separately and will be assessed by asking the patient to rate their pain level on a scale of 0 to 10, 0 being no pain and 10 being unbearable, excruciating pain. A member of the research team will make these evaluations at each time point. All five of these would be assessed as part of the standard of care for mini-screw placement, regardless of participation in the research study or lack thereof. The only action related to the research that is not standard of care is the dispensing of either the antibiotic or the placebo at 1 hour prior to mini-screw placement.
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.
If the mini-screw implants fail, the participants will have the mini-screw removed. It is up to assigned instructors as to whether or not mini-screws will be replaced. If the mini-screws will not be replaced, the patient will be removed from the study, but all data collected will be included in the research.
Standard of Care will be followed in all instances at time points T(0), T(1), T(2) and T(3).
The dependent variable will be success or failure, while the independent variable will be antibiotic prophylaxis or placebo. Failure will be defined as mobile or lost MSIs, and success will be defined as stability of the MSIs maintained after 6 months. 8mm long, 1.5 mm diameter, palatally placed MSIs provided by a single manufacturer (Forestadent) that are immediately force loaded or delayed in force loading will be included in the study. Data will be analyzed with SPSS for Windows (SPSS Inc., Chicago, Ill). A Chi Square test for independence will be used to determine association, if any, between the two categorical variables. This study will establish an alpha of 0.05 and a beta of 0.08322, and to achieve power of 0.91, a sample size of 100 subjects is the goal for recruiting.
- Being tested
- Amoxicillin, Placebo oral capsule
- Keywords
- antibiotics, prophylaxis, temporary anchorage devices, mini-screw implants, TADs, MSIs, failure rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
see previous descriptions
Placebo oral capsuleDrug
see previous descriptions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T(3) at 6 months post-placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start7 Aug 2018
- Primary completion1 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Inflammation at Mini-screw Insertion SiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byron Schroeder, DDS, St. Louis University
- Investigators
- Hiroshi Ueno, DDS, Study chair, Full time faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582605
- Sponsor's protocol ID
- 29379
- Status last verified
- Nov 2020
- First submitted
- 26 Jun 2018
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Publications
Berens A, Wiechmann D & Rudiger J. "L'ancrage intra-osseux en orthodontie a' l'aide de mini et de microvis." International Orthodontics (2005) 3: 235-43.
Carano A, Melsen B. Implants in orthodontics. Interview. Prog Orthod. 2005;6(1):62-9. No abstract available. English, Italian.
PubMed 15891785Cope J. "Temporary anchorage devices in orthodontics: a paradigm shift." Seminars in Orthodontics (2005)11:3-9.
Costa A, Raffainl M, Melsen B. Miniscrews as orthodontic anchorage: a preliminary report. Int J Adult Orthodon Orthognath Surg. 1998;13(3):201-9.
PubMed 9835819Esposito 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.
PubMed 23904048Esposito 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.
PubMed 9672097Flemmig TF & Newman MG. "Antimicrobials in implant dentistry." In: Newman MG, Kornman K editor. Antibiotics/antimicrobial use in dental practice. Chicago: Quintessence Publishing Co, Inc,(1990):187-200.
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.
PubMed 11488865Fritz U, Ehmer A, Diedrich P. Clinical suitability of titanium microscrews for orthodontic anchorage-preliminary experiences. J Orofac Orthop. 2004 Sep;65(5):410-8. doi: 10.1007/s00056-004-0408-x. English, German.
PubMed 15378195Gray JB, Steen ME, King GJ, Clark AE. Studies on the efficacy of implants as orthodontic anchorage. Am J Orthod. 1983 Apr;83(4):311-7. doi: 10.1016/0002-9416(83)90226-9.
PubMed 6573144Heymann GC, Tulloch JF. Implantable devices as orthodontic anchorage: a review of current treatment modalities. J Esthet Restor Dent. 2006;18(2):68-79; discussion 80. doi: 10.2310/6130.2006.00013_1.x.
PubMed 16519871Kanomi R. Mini-implant for orthodontic anchorage. J Clin Orthod. 1997 Nov;31(11):763-7. No abstract available.
PubMed 9511584Lee 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.
PubMed 20152674Miyawaki 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.
PubMed 14560266Odman 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.
PubMed 3164683
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis Prior to the Insertion of Orthodontic Mini-screw Implants: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03582605
- Acronym / sponsor ID
- 29379
- Keywords
- antibiotics, prophylaxis, temporary anchorage devices, mini-screw implants, TADs, MSIs, failure rate
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will be selected for the study based on treatment plans for Phase II orthodontics at Saint Louis University Center for Advanced Dental Education orthodontics program, which require the use of palatally placed mini-screw implants for anchorage control. If the patient is at or beyond the age of 18 years, they will be approached about this study. If the patient is under the age of 18 years, the parent or legal guardian of the patient will be approached. After the consult is completed, where the treatment plan has been explained and standard consent forms have been signed, a member of the research team will verbally confirm with the patient or the patient and parent/guardian that the patient cannot be excluded from the study based on exclusion criteria from the patient's medical history. Orthodontic treatment at SLU CADE involves monthly visits to the orthodontic clinic where patients receive orthodontic treatment, including leveling and aligning of teeth with archwires and fixed appliances on teeth, space closure, occlusion correction, and finishing and detailing. Mini-screw placement is not necessary nor included in all treatment plans given at SLU CADE orthodontics. The possible subjects for the study will patients who will receive mini-screw implants as a course of their treatment for orthodontic anchorage (standard of care).
Participants will be weighed so that appropriate dosing can be ensured and randomized 1:1 to receive either and antibiotic (Amoxicillin) or a placebo (glucose) 1 hour prior to mini-screw insertion (research related). Patients weighing less than 40 kg will be given 50mg/kg. The Amoxicillin and the placebo (glucose) will be prepared in capsule form by a pharmacist and made to look identical. The Amoxicillin or placebo will be dispensed at CADE and taken at CADE 1 hour prior to the procedure. Standard procedure for dispensing Amoxicillin at SLU CADE is to draw appropriate dosage from the dispensary and provide Amoxicillin to at risk patients prior to invasive dental procedures, in accordance with prophylaxis guidelines set form by the American Heart Association. Documentation of dosage and time of dispensing is noted in the patient record. However, in this study, documentation in the patient dental record will only reflect that either a placebo or Amoxicillin was given as part of a randomized controlled trial. Standard of care for orthodontic mini-screw implants includes oral hygiene instructions and 1 week of oral antibiotic mouth rinse use (.12% Chlorhexidine) and all participants in this study will follow standard of care in addition to the administration of either placebo or antibiotic. Randomization between control or experimental group will be conducted by the Research Chair, Hiroshi Ueno, and the PI will have no knowledge of to which group subjects are assigned.
Participants will be followed at time of mini-screw placement (T0), 1 month post procedure (T1), 3 months post-procedure (T2), and 6 months post-procedure (T3). The participant has standard of care appointments at these time points, so there are not any extra visits for research purposes. At these appointment, 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, assess oral hygiene at the site of mini-screw placement, and be asked to rate both their pain and tenderness related to the mini-screw. Pain is defined as spontaneous pain frim the mini-screw site. Tenderness is defined as pain resulting from palpation of the mini-screw. 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). Oral hygiene will be assessed as having no visible plaque at the site (Grade 0), having small amounts of plaque at the site (Grade 1), or having moderate to large amounts of plaque at the site (Grade 2). Pain and tenderness will be evaluated separately and will be assessed by asking the patient to rate their pain level on a scale of 0 to 10, 0 being no pain and 10 being unbearable, excruciating pain. A member of the research team will make these evaluations at each time point. All five of these would be assessed as part of the standard of care for mini-screw placement, regardless of participation in the research study or lack thereof. The only action related to the research that is not standard of care is the dispensing of either the antibiotic or the placebo at 1 hour prior to mini-screw placement.
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.
If the mini-screw implants fail, the participants will have the mini-screw removed. It is up to assigned instructors as to whether or not mini-screws will be replaced. If the mini-screws will not be replaced, the patient will be removed from the study, but all data collected will be included in the research.
Standard of Care will be followed in all instances at time points T(0), T(1), T(2) and T(3).
The dependent variable will be success or failure, while the independent variable will be antibiotic prophylaxis or placebo. Failure will be defined as mobile or lost MSIs, and success will be defined as stability of the MSIs maintained after 6 months. 8mm long, 1.5 mm diameter, palatally placed MSIs provided by a single manufacturer (Forestadent) that are immediately force loaded or delayed in force loading will be included in the study. Data will be analyzed with SPSS for Windows (SPSS Inc., Chicago, Ill). A Chi Square test for independence will be used to determine association, if any, between the two categorical variables. This study will establish an alpha of 0.05 and a beta of 0.08322, and to achieve power of 0.91, a sample size of 100 subjects is the goal for recruiting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Placebo oral capsuleAll participants will be weighed. This group will receive a placebo (glucose) 1 hour prior to insertion of mini-screw implants. |
| Experimental Group | Experimental | Drug: AmoxicillinAll 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillinsee previous descriptions | Drug | Experimental Group |
| Placebo oral capsulesee previous descriptions | Drug | Control Group |
Primary outcome
Mini-screw implant success or failure
Time frame: T(0) at time of insertion
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.
Mini-screw implant success or failure
Time frame: T(1) at 1 month post-placement
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.
Mini-screw implant success or failure
Time frame: T(2) at 3 months post-placement
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.
Mini-screw implant success or failure
Time frame: T(3) at 6 months post-placement
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- BackgroundBerens A, Wiechmann D & Rudiger J. "L'ancrage intra-osseux en orthodontie a' l'aide de mini et de microvis." International Orthodontics (2005) 3: 235-43.
- Background: PubMed 15891785Carano A, Melsen B. Implants in orthodontics. Interview. Prog Orthod. 2005;6(1):62-9. No abstract available. English, Italian.
- BackgroundCope J. "Temporary anchorage devices in orthodontics: a paradigm shift." Seminars in Orthodontics (2005)11:3-9.
- Background: PubMed 9835819Costa A, Raffainl M, Melsen B. Miniscrews as orthodontic anchorage: a preliminary report. Int J Adult Orthodon Orthognath Surg. 1998;13(3):201-9.
- Background: PubMed 23904048Esposito 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.
- Background: PubMed 9672097Esposito 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.
- BackgroundFlemmig TF & Newman MG. "Antimicrobials in implant dentistry." In: Newman MG, Kornman K editor. Antibiotics/antimicrobial use in dental practice. Chicago: Quintessence Publishing Co, Inc,(1990):187-200.
- Background: PubMed 11488865Freudenthaler 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.
- Background: PubMed 15378195Fritz U, Ehmer A, Diedrich P. Clinical suitability of titanium microscrews for orthodontic anchorage-preliminary experiences. J Orofac Orthop. 2004 Sep;65(5):410-8. doi: 10.1007/s00056-004-0408-x. English, German.
- Background: PubMed 6573144Gray JB, Steen ME, King GJ, Clark AE. Studies on the efficacy of implants as orthodontic anchorage. Am J Orthod. 1983 Apr;83(4):311-7. doi: 10.1016/0002-9416(83)90226-9.
- Background: PubMed 16519871Heymann GC, Tulloch JF. Implantable devices as orthodontic anchorage: a review of current treatment modalities. J Esthet Restor Dent. 2006;18(2):68-79; discussion 80. doi: 10.2310/6130.2006.00013_1.x.
- Background: PubMed 9511584Kanomi R. Mini-implant for orthodontic anchorage. J Clin Orthod. 1997 Nov;31(11):763-7. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroshi Ueno, DDS study chair
Full time faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Amoxicillin in people with Inflammation at Mini-screw Insertion Site and Mobility, Mini-screw, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-screw implant success or failure (time frame: T(0) at time of insertion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03582605, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.