Peri-ImplantitisNCT03384446
Dental Hygiene and Peri-Implant Tissues Homeostasis
A study testing Tooth-borne treatment and Implant-specific treatment in people with Peri-Implantitis, run by University of Washington at 2 sites in United States.
Trial summary
Dental implants have revolutionized the field of dentistry, providing improvements in function and esthetics. They are not, however, without risks. Bone loss around implants (i.e. periimplantitis) is an emerging public health concern. Untreated, peri-implantitis leads to implant loss and jawbone defects. 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?
- Tooth-borne treatment and Implant-specific treatment
- 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 10 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, Department of Periodontics
Seattle, Washington, 98195
About this study
Official title: The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I
Dental implants have revolutionized the field of dentistry, providing improvements in function and esthetics. They are not, however, without risks. Bone loss around implants (i.e. periimplantitis) is an emerging public health concern. Untreated, peri-implantitis leads to implant loss and jawbone defects. Nonetheless, existing therapies have failed to show long-term efficacy. The pathogenesis of peri-implantitis is believed to be of bacterial etiology similar to periodontal disease. Therefore, existing treatments duplicate strategies for the treatment of natural teeth. However, the titanium (Ti) surface of implants is quite dissimilar to teeth. Recent work from our lab has demonstrated that peri-implantitis is associated with increased release of Ti particles around implants. These findings suggest that treatments targeting periimplantitis must be designed around Ti material properties. A gap in knowledge exists regarding the potential triggers of increased Ti dissolution from the implant surface and the mechanisms by which Ti dissolution products amplify peri-implant inflammation. The aim of this study is to determine if the use of tooth-driven treatment approaches increase Ti in the submucosal plaque.
- Conditions
- Peri-Implantitis
- Being tested
- Tooth-borne treatment, Implant-specific treatment
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth-borne treatmentOther
Titanium curettes
Implant-specific treatmentOther
Implant brush
| Study group | Role | What they receive |
|---|---|---|
| Tooth-borne treatment | Active comparator | A cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning. Receives: Other: Tooth-borne treatment |
| Implant-specific treatment | Experimental | A cleaning aid that has been specifically designed for implant surface cleaning. Receives: Other: Implant-specific treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titanium elution
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)
Measured: 8 weeks
Secondary outcomes (3)
Probing depth reduction
Probing depth reduction following surgical peri-implant treatment
Measured: 5 months, 12 months
BOP reduction
Changes in % bleeding on probing following surgical peri-implant treatment
Measured: 5 months, 12 months
Bone level changes
Changes in peri-implant bone level as assessed via standardized radiographs
Measured: 5 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start22 Nov 2017
- Primary completion1 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- 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
- Osteogenics Biomedical
- Responsible party
- Principal investigator, Giorgios Kotsakis, University of Washington
- Investigators
- Georgios Kotsakis, DDS, MS, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384446
- Sponsor's protocol ID
- STUDY00002852
- Status last verified
- Jun 2023
- First submitted
- 19 Dec 2017
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Daubert D, Lee E, Botto A, Eftekhar M, Palaiologou A, Kotsakis GA. Assessment of titanium release following non-surgical peri-implantitis treatment: A randomized clinical trial. J Periodontol. 2023 Sep;94(9):1122-1132. doi: 10.1002/JPER.22-0716. Epub 2023 May 2.
PubMed 37070363Kotsakis GA, Botto A, Jazaeri MS, Palaiologou A, Lee E, Daubert DM. Impact of abrasive versus non-abrasive cleaning on peri-implantitis titanium release: A randomized clinical trial. J Periodontol. 2026 Jun 18. doi: 10.1002/jper.70158. Online ahead of print.
PubMed 42316309
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
- ClinicalTrials.gov ID
- NCT03384446
- Acronym / sponsor ID
- STUDY00002852
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Osteogenics Biomedical
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 27 Dec 2017 (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.
Dental implants have revolutionized the field of dentistry, providing improvements in function and esthetics. They are not, however, without risks. Bone loss around implants (i.e. periimplantitis) is an emerging public health concern. Untreated, peri-implantitis leads to implant loss and jawbone defects. Nonetheless, existing therapies have failed to show long-term efficacy. The pathogenesis of peri-implantitis is believed to be of bacterial etiology similar to periodontal disease. Therefore, existing treatments duplicate strategies for the treatment of natural teeth. However, the titanium (Ti) surface of implants is quite dissimilar to teeth. Recent work from our lab has demonstrated that peri-implantitis is associated with increased release of Ti particles around implants. These findings suggest that treatments targeting periimplantitis must be designed around Ti material properties. A gap in knowledge exists regarding the potential triggers of increased Ti dissolution from the implant surface and the mechanisms by which Ti dissolution products amplify peri-implant inflammation. The aim of this study is to determine if the use of tooth-driven treatment approaches increase Ti in the submucosal plaque.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tooth-borne treatment | Active comparator | Other: Tooth-borne treatmentA cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning. |
| Implant-specific treatment | Experimental | Other: Implant-specific treatmentA cleaning aid that has been specifically designed for implant surface cleaning. |
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 (7 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?
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 |
|---|---|---|
| Tooth-borne treatmentTitanium curettes | Other | Tooth-borne treatment |
| Implant-specific treatmentImplant brush | Other | Implant-specific treatment |
Primary outcome
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)
3 secondary outcomes
Probing depth reduction
Time frame: 5 months, 12 months
BOP reduction
Time frame: 5 months, 12 months
Bone level changes
Time frame: 5 months, 12 months
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.
- Results publication: PubMed 37070363Daubert D, Lee E, Botto A, Eftekhar M, Palaiologou A, Kotsakis GA. Assessment of titanium release following non-surgical peri-implantitis treatment: A randomized clinical trial. J Periodontol. 2023 Sep;94(9):1122-1132. doi: 10.1002/JPER.22-0716. Epub 2023 May 2.
- Derived from this study: PubMed 42316309Kotsakis GA, Botto A, Jazaeri MS, Palaiologou A, Lee E, Daubert DM. Impact of abrasive versus non-abrasive cleaning on peri-implantitis titanium release: A randomized clinical trial. J Periodontol. 2026 Jun 18. doi: 10.1002/jper.70158. Online ahead of print.
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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
Assistant Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth-borne treatment and Implant-specific treatment 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 7 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 elution (time frame: 8 weeks). 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 NCT03384446, which also lists 2 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 5 Jul 2023.