Antiseptic Effects on the Dental Implant Internal Surface Microbiome

NCT05024760 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: Pending
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Soldiers operate in environments that are more likely to lead to oral trauma, risking poor dentition which can directly impact military readiness. Dental restoration can often be accomplished via dental implant insertion. Microbiome-associated complications that result in bone loss, including the micro-leakage of bacterial species proliferating in the dental implant internal cavity, frequently lead to implant failure. Reduction in implant bacterial load may result in a shift of the composition of the microbiome in favor of less pathogenic species, potentially improving dental implant success rates, reducing surgical revisions, and associated cost savings. This study aims to determine how disinfectant gel (hydrogen peroxide or chlorhexidine) insertion into dental implant internal cavities affects implant failure rates, bacterial load and microbiome composition.

Conditions

Peri-Implantitis; Peri-implant Mucositis; Implant Infection; Dental Implant Failed

Outcome Measures

Primary Outcomes (1)

• Implant Failure

  We will compare the rates of dental implant failure between study arms.

  Four months post dental implant insertion.

Secondary Outcomes (3)

• Peri-Implantitis

  Four months post dental implant insertion.

• Bacterial Load

  Four months post dental implant insertion.

• Microbiome Composition

  Four months post dental implant insertion.

Study Arms (3)

Control

NO INTERVENTION

This arm will receive standard of care during dental implant insertion.

Chlorhexidine

EXPERIMENTAL

Chlorhexidine treatment.

Drug: Chlorhexidine

Hydrogen Peroxide

EXPERIMENTAL

Hydrogen Peroxide treatment.

Drug: Hydrogen Peroxide

Interventions

Chlorhexidine DRUG

Chlorhexidine will be inserted into the dental implant internal cavity during dental implant insertion.

Chlorhexidine

Hydrogen Peroxide DRUG

Hydrogen Peroxide will be inserted into the internal cavity of the dental implant during dental implant insertion.

Hydrogen Peroxide

Eligibility Criteria

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

You may qualify if:

• Active duty military
• years old
• Over 6 months remaining at local duty station

You may not qualify if:

• Tobacco user
• Medications that affect soft tissue or bone healing
• Metabolic disorder that affects soft tissue or bone healing
• Active periodontal disease

Sponsors & Collaborators

• Madigan Army Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

RECRUITING

Related Publications (13)

• Battle-Siatita SO, Bartoloni JA, Hancock RH, Chong CH. Retrospective analysis of dental implants among United States Air Force basic military trainees. Mil Med. 2009 Apr;174(4):437-40. doi: 10.7205/milmed-d-02-5008.

  PMID: 19485117 BACKGROUND

• Atieh MA, Alsabeeha NH, Faggion CM Jr, Duncan WJ. The frequency of peri-implant diseases: a systematic review and meta-analysis. J Periodontol. 2013 Nov;84(11):1586-98. doi: 10.1902/jop.2012.120592. Epub 2012 Dec 13.

  PMID: 23237585 BACKGROUND

• Podhorsky A, Biscoping S, Rehmann P, Streckbein P, Domann E, Wostmann B. Transfer of Bacteria into the Internal Cavity of Dental Implants After Application of Disinfectant or Sealant Agents In Vitro. Int J Oral Maxillofac Implants. 2016 May-Jun;31(3):563-70. doi: 10.11607/jomi.4408.

  PMID: 27183065 BACKGROUND

• Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.

  PMID: 29926957 BACKGROUND

• Solderer A, Kaufmann M, Hofer D, Wiedemeier D, Attin T, Schmidlin PR. Efficacy of chlorhexidine rinses after periodontal or implant surgery: a systematic review. Clin Oral Investig. 2019 Jan;23(1):21-32. doi: 10.1007/s00784-018-2761-y. Epub 2018 Dec 7.

  PMID: 30535817 BACKGROUND

• Daubert DM, Weinstein BF. Biofilm as a risk factor in implant treatment. Periodontol 2000. 2019 Oct;81(1):29-40. doi: 10.1111/prd.12280.

  PMID: 31407437 BACKGROUND

• Besimo CE, Guindy JS, Lewetag D, Meyer J. Prevention of bacterial leakage into and from prefabricated screw-retained crowns on implants in vitro. Int J Oral Maxillofac Implants. 1999 Sep-Oct;14(5):654-60.

  PMID: 10531737 BACKGROUND

• Duarte AR, Rossetti PH, Rossetti LM, Torres SA, Bonachela WC. In vitro sealing ability of two materials at five different implant-abutment surfaces. J Periodontol. 2006 Nov;77(11):1828-32. doi: 10.1902/jop.2006.060101.

  PMID: 17076607 BACKGROUND

• Podhorsky A, Putzier S, Rehmann P, Streckbein P, Domann E, Wostmann B. Bacterial Contamination of the Internal Cavity of Dental Implants After Application of Disinfectant or Sealant Agents Under Cyclic Loading In Vitro. Int J Prosthodont. 2016 Sep-Oct;29(5):493-5. doi: 10.11607/ijp.4546.

  PMID: 27611755 BACKGROUND

• Carinci F, Lauritano D, Bignozzi CA, Pazzi D, Candotto V, Santos de Oliveira P, Scarano A. A New Strategy Against Peri-Implantitis: Antibacterial Internal Coating. Int J Mol Sci. 2019 Aug 9;20(16):3897. doi: 10.3390/ijms20163897.

  PMID: 31405061 BACKGROUND

• D'Ercole S, Tete S, Catamo G, Sammartino G, Femminella B, Tripodi D, Spoto G, Paolantonio M. Microbiological and biochemical effectiveness of an antiseptic gel on the bacterial contamination of the inner space of dental implants: a 3-month human longitudinal study. Int J Immunopathol Pharmacol. 2009 Oct-Dec;22(4):1019-26. doi: 10.1177/039463200902200417.

  PMID: 20074465 BACKGROUND

• Ghannad F, Alkadi LT, Wiebe CB, Shen Y, Haapasalo M, Larjava HS. Intra-operative application of chlorhexidine gel reduces bacterial counts in internal implant cavity. Eur J Oral Sci. 2015 Dec;123(6):425-31. doi: 10.1111/eos.12213. Epub 2015 Sep 28.

  PMID: 26411835 BACKGROUND

• Paolantonio M, Perinetti G, D'Ercole S, Graziani F, Catamo G, Sammartino G, Piccolomini R. Internal decontamination of dental implants: an in vivo randomized microbiologic 6-month trial on the effects of a chlorhexidine gel. J Periodontol. 2008 Aug;79(8):1419-25. doi: 10.1902/jop.2008.070660.

  PMID: 18672991 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Chlorhexidine; Hydrogen Peroxide

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds

Central Study Contacts

Kevin D Smith, DMD

CONTACT

253-968-0181; kevin.d.smith2.mil@health.mil

Zachary T Colburn, PhD

CONTACT

253-968-3455; zachary.t.colburn.civ@health.mil

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a 3 arm study with 1 arm receiving no treatment and 2 arms receiving treatments.

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: July 28, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)