NCT03384446

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2023

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

5.5 years

First QC Date

December 19, 2017

Last Update Submit

June 30, 2023

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

  • 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)

    8 weeks

Secondary Outcomes (3)

  • Probing depth reduction

    5 months, 12 months

  • BOP reduction

    5 months, 12 months

  • Bone level changes

    5 months, 12 months

Study Arms (2)

Tooth-borne treatment

ACTIVE COMPARATOR

A cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning.

Other: Tooth-borne treatment

Implant-specific treatment

EXPERIMENTAL

A cleaning aid that has been specifically designed for implant surface cleaning.

Other: Implant-specific treatment

Interventions

Tooth-borne treatmentOTHER

Titanium curettes

Tooth-borne treatment
Implant-specific treatmentOTHER

Implant brush

Implant-specific treatment

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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?

You may not qualify if:

  • 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?

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UTHealth San Antonio

San Antonio, Texas, 78229, United States

Location

University of Washington, Department of Periodontics

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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.

    PMID: 37070363RESULT

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Georgios Kotsakis, DDS, MS

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will not know which intervention was administered. Outcome assessor will be different than care provider and will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, School of Dentistry:Dept. of Periodontics

Study Record Dates

First Submitted

December 19, 2017

First Posted

December 27, 2017

Study Start

November 22, 2017

Primary Completion

June 1, 2023

Study Completion

June 10, 2023

Last Updated

July 5, 2023

Record last verified: 2023-06

Locations

US(2)