Dental Hygiene and Peri-Implant Tissues Homeostasis
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|ClinicalTrials.gov Identifier: NCT03384446|
Recruitment Status : Active, not recruiting
First Posted : December 27, 2017
Last Update Posted : November 14, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Peri-Implantitis||Other: Tooth-borne treatment Other: Implant-specific treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Participants will not know which intervention was administered. Outcome assessor will be different than care provider and will be masked.|
|Official Title:||The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I|
|Actual Study Start Date :||November 22, 2017|
|Estimated Primary Completion Date :||April 15, 2023|
|Estimated Study Completion Date :||April 15, 2023|
Active Comparator: Tooth-borne treatment
A cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning.
Other: Tooth-borne treatment
Experimental: Implant-specific treatment
A cleaning aid that has been specifically designed for implant surface cleaning.
Other: Implant-specific treatment
- Titanium elution [ Time Frame: 8 weeks ]The primary outcome of the clinical trial will be titanium dissolution in periimplant plaque at 8 weeks following treatment quantified using inductively coupled mass spectrometry (ICMS)
- Probing depth reduction [ Time Frame: 5 months, 12 months ]Probing depth reduction following surgical peri-implant treatment
- BOP reduction [ Time Frame: 5 months, 12 months ]Changes in % bleeding on probing following surgical peri-implant treatment
- Bone level changes [ Time Frame: 5 months, 12 months ]Changes in peri-implant bone level as assessed via standardized radiographs
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||25 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Is the subject ≥ 25 years of age?
- Does the subject have an implant with a probing depth ≥ 5mm, bleeding on probing, and radiographic bone loss of > 2mm?
- Is the subject committed to the study and the required follow-up visits?
- Is the subject immune compromised?
- Is the subject diabetic?
- Does the subject take steroid medication?
- Does the subject regularly use non-steroidal anti-inflammatories?
- Is the subject pregnant or intending to become pregnant during the duration of the study?
- Has the subject had previous implantoplasty?
- Did the subject take any antibiotics in the last 3 months?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384446
|United States, Texas|
|UTHealth San Antonio|
|San Antonio, Texas, United States, 78229|
|United States, Washington|
|University of Washington, Department of Periodontics|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Georgios Kotsakis, DDS, MS||Assistant Professor|
|Responsible Party:||Giorgios Kotsakis, Assistant Professor, School of Dentistry:Dept. of Periodontics, University of Washington|
|Other Study ID Numbers:||
|First Posted:||December 27, 2017 Key Record Dates|
|Last Update Posted:||November 14, 2022|
|Last Verified:||November 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|