Peri-Implantitis Clinical Trial
Official title:
Antiseptic Effects on the Dental Implant Internal Surface Microbiome
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | April 2024 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Active duty military - 18-55 years old - Over 6 months remaining at local duty station Exclusion Criteria: - Tobacco user - Medications that affect soft tissue or bone healing - Metabolic disorder that affects soft tissue or bone healing - Active periodontal disease |
Country | Name | City | State |
---|---|---|---|
United States | Madigan Army Medical Center | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Madigan Army Medical Center | United States Department of Defense |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implant Failure | We will compare the rates of dental implant failure between study arms. | Four months post dental implant insertion. | |
Secondary | Peri-Implantitis | We will compare the rates of peri-implantitis between study arms. | Four months post dental implant insertion. | |
Secondary | Bacterial Load | We will compare the bacterial load in the dental implant internal cavity between study arms. | Four months post dental implant insertion. | |
Secondary | Microbiome Composition | We will compare the relative abundance of red and orange complex bacteria in the dental implant internal cavity between study arms. | Four months post dental implant insertion. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05332327 -
Comparison of the Accuracy of Different Periodontal Probes for Peri-implant Pocket Registration
|
||
Enrolling by invitation |
NCT06063876 -
Experimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without Implantoplasty
|
N/A | |
Completed |
NCT04249024 -
Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery
|
N/A | |
Withdrawn |
NCT03624257 -
Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery
|
N/A | |
Completed |
NCT02375750 -
Treatment of Peri-implantitis Lesions by Using Biomaterial
|
N/A | |
Completed |
NCT03157193 -
Effect of Hyaluronic Acid on Perimplantitis
|
Phase 4 | |
Completed |
NCT03018795 -
Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis
|
N/A | |
Enrolling by invitation |
NCT02575274 -
Peri-Implantitis Surgical Treatment an RCT Study
|
Phase 2/Phase 3 | |
Completed |
NCT04833569 -
ICG-PDT, Periimplantitis, Diabetes Mellitus
|
Phase 1 | |
Not yet recruiting |
NCT04337645 -
Resective Surgical Treatment of Peri-implantitis.
|
N/A | |
Enrolling by invitation |
NCT06033859 -
Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression
|
||
Active, not recruiting |
NCT06390124 -
Reconstructive Therapy of Peri-implantitis With PDGF-BB (Gem-21)
|
Phase 4 | |
Enrolling by invitation |
NCT05675241 -
Characterizing the Inflammation Around Dental Implants
|
||
Recruiting |
NCT04983758 -
20-year Implant Survival in Periodontally Healthy and Compromised Patients
|
||
Completed |
NCT04769609 -
Reconstructive Surgical Therapy of Peri-implantitis
|
||
Not yet recruiting |
NCT04323540 -
Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation
|
N/A | |
Completed |
NCT04874467 -
Influence of Keratinized Mucosa on Dental Implants With Mucositis
|
N/A | |
Completed |
NCT05724706 -
An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease
|
||
Completed |
NCT04559841 -
Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin
|
N/A | |
Recruiting |
NCT05906810 -
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis
|
N/A |