Peri-ImplantitisNCT03917264
Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study
A study testing Peri-implantitis debridement and Dental hygiene procedures in people with Peri-Implantitis, run by University of Washington at 2 sites in United States.
Trial summary
Peri-implantitis is an inflammatory disease that leads to loss of jawbone around dental implants. Recent discoveries have identified increased release of Titanium (Ti) particles around implants as being associated to peri-implantitis. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Peri-implantitis debridement and Dental hygiene procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Nov 2017to 1 Jun 2023
- Phase
- Interventional
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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?
Who cannot join
- 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?
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UTHealth San Antonio
San Antonio, Texas, 78229
University of Washington School of Dentistry
Seattle, Washington, 98155
About this study
Official title: The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I (Ancillary Study)
Peri-implantitis is an inflammatory disease that leads to loss of jawbone around dental implants. Recent discoveries have identified increased release of Titanium (Ti) particles around implants as being associated to peri-implantitis. In this ancillary study to the Dental Hygiene and Peri-Implant Tissues Homeostasis trial the objective is to determine potential triggers of increased Ti dissolution from the implant surface and the mechanisms by which Ti dissolution products amplify peri-implant inflammation. Results from this study will determine whether there is a differential response to Ti particles across individuals, which may alter susceptibility to peri-implantitis.
- Conditions
- Peri-Implantitis
- Being tested
- Peri-implantitis debridement, Dental hygiene procedures
- Keywords
- implant, titanium, dental
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-implantitis debridementProcedure or surgery
Mechanical cleaning of titanium implants, peri-implantitis debridement.
Dental hygiene proceduresOther
Titanium scalers and nylon brushed used for implant cleaning
| Study group | Role | What they receive |
|---|---|---|
| Tooth-borne treatment | Active comparator | Titanium curettes Receives: Procedure: Peri-implantitis debridement; Other: Dental hygiene procedures |
| Implant-specific treatment | Experimental | Implant brush Receives: Procedure: Peri-implantitis debridement; Other: Dental hygiene procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titanium Dissolution
The primary outcome of the clinical trial will be titanium dissolution in periimplant plaque following treatment quantified using inductively coupled mass spectrometry (ICMS)
Measured: 12 weeks +/- 4 weeks
Secondary outcomes (1)
Expression of pro-inflammatory cytokines in response to titanium
We will determine whether PBMCs from peri-implantitis persons and controls have a differential pro-inflammatory response to titanium particles.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start22 Nov 2017
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Royalty Research Fund - University of Washington
- Responsible party
- Principal investigator, Giorgios Kotsakis, University of Washington
- Investigators
- Georgios Kotsakis, DDS, MS, Principal investigator, UTHealth San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917264
- Sponsor's protocol ID
- STUDY00002852A
- Status last verified
- Jun 2023
- First submitted
- 1 May 2018
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I (Ancillary Study)
- ClinicalTrials.gov ID
- NCT03917264
- Acronym / sponsor ID
- STUDY00002852A
- Conditions
- Peri-Implantitis
- Keywords
- implant, titanium, dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Royalty Research Fund - University of Washington
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 17 Apr 2019 (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.
Peri-implantitis is an inflammatory disease that leads to loss of jawbone around dental implants. Recent discoveries have identified increased release of Titanium (Ti) particles around implants as being associated to peri-implantitis. In this ancillary study to the Dental Hygiene and Peri-Implant Tissues Homeostasis trial the objective is to determine potential triggers of increased Ti dissolution from the implant surface and the mechanisms by which Ti dissolution products amplify peri-implant inflammation. Results from this study will determine whether there is a differential response to Ti particles across individuals, which may alter susceptibility to peri-implantitis.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tooth-borne treatment | Active comparator | Procedure: Peri-implantitis debridement, Other: Dental hygiene proceduresTitanium curettes |
| Implant-specific treatment | Experimental | Procedure: Peri-implantitis debridement, Other: Dental hygiene proceduresImplant brush |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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?
Key exclusion criteria (1 listed)
- 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?
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 |
|---|---|---|
| Peri-implantitis debridementMechanical cleaning of titanium implants, peri-implantitis debridement. | Procedure or surgery | Implant-specific treatment, Tooth-borne treatment |
| Dental hygiene proceduresTitanium scalers and nylon brushed used for implant cleaning | Other | Implant-specific treatment, Tooth-borne treatment |
Primary outcome
Titanium Dissolution
Time frame: 12 weeks +/- 4 weeks
The primary outcome of the clinical trial will be titanium dissolution in periimplant plaque following treatment quantified using inductively coupled mass spectrometry (ICMS)
1 secondary outcome
Expression of pro-inflammatory cytokines in response to titanium
Time frame: baseline
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 5 Jul 2023.
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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.
Georgios Kotsakis, DDS, MS principal investigator
UTHealth San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peri-implantitis debridement and Dental hygiene procedures in people with Peri-Implantitis, run by University of Washington at 2 sites 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 3 inclusion and 1 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 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Titanium Dissolution (time frame: 12 weeks +/- 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2023.