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PeriimplantitisNCT03753464

The Role of Functional Epigenetic Modifications in Peri-Implantitis

An observational study of Periimplantitis, run by NYU College of Dentistry at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this pilot, exploratory, single blind clinical trial is to evaluate the epigenetic changes associated with peri-implantitis. Read more about this study

Who is it for?
Ages 20 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Periimplantitis
What is being tested?
Gingival biopsy and blood sample collection
Type of treatment
Surgery or procedure
How many people
15 participants
Where
1 siteUnited States
Study dates
4 Oct 2018to 2 Jul 2019
Phase
Observational
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 20 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: * Periodontally Healthy Subjects * Peri-implantitis Subjects

Who may be able to join

  • General Inclusion Criteria:
  • Subjects must have read, understood, and signed an informed consent form.
  • Subjects must be 20-90 years of age.
  • Subjects must be non-smokers or ex-smokers who have quit smoking for at least one year prior to enrollment in the study.
  • Subjects must be in good general health as assessed by the Investigator.
  • Healthy Periodontal Subjects Inclusion Criteria:
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  • In addition to the general inclusion criteria, a healthy periodontal subject must meet all of the following criteria:
  • Subjects show gingival health and no history of periodontitis, as described in the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
  • Peri-implantitis Subjects Inclusion Criteria:
  • In addition to the general inclusion criteria, a PIT subject must meet all of the following criteria:
  • Subjects with implant-supported prosthesis/es in function for at least 12 months who had at least one implant diagnosed with peri-implantitis based on the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
  • Subjects must be committed to the study and the required follow-up visits.
  • Standard of care treatment of the diseased implant with PID will consist on open flap debridement (OFD).

Who cannot join

  • General Exclusion Criteria:
  • Pregnant or lactating.
  • Use of antibiotics, within 1 month before enrollment in the study.
  • Chronic use of nonsteroidal anti-inflammatory drugs for over 3 weeks of continuous use at the time of enrollment or during the course of the study.
  • Requirement for prophylactic antibiotics for dental procedures.
  • Mucosal diseases in the localized area around the biopsy site.
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  • Subjects with a systemic disease that would preclude biopsy/oral surgery.
  • History of local irradiation therapy in the head/neck area.
  • Subjects with poor oral hygiene.
  • Subjects receiving, or having a history of receiving intravenous or subcutaneous anti-resorptive agents associated with osteonecrosis of the jaw.
  • Subjects with any untreated endodontic lesions or untreated periodontal disease adjacent to the biopsy site.
  • Acute necrotizing ulcerative gingivitis or gross tooth decay, as determined by the investigator.
  • Subjects with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis.
  • Periodontally Healthy Subjects Exclusion:
  • In addition to the general exclusion criteria, subjects allocated to the healthy group who meet any of the following criteria will be excluded from participation in this study:
  • Root fragments, pericoronitis, endo-perio lesions, gross tooth decay, or other dental abscesses at the biopsy site. Subjects may be rescreened after resolution of these dental conditions.
  • Peri-implantitis subjects Exclusion:
  • In addition to the general exclusion criteria, subjects allocated to the PIT group who meet any of the following criteria will be excluded from participation in this study:
  • Inadequate implant position (i.e., prosthetically driven).
  • PIT due to excess of cement.
  • Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene.
  • Subjects with implants previously surgically treated for PIT.
  • Less than 2mm of keratinized peri-implant tissue.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Bluestone Center for Clinical Research. New York University College of Dentistry

    New York, New York, 10010-4086

Other trials in United States

About this study

Official title: The Role of Functional Epigenetic Modifications in Peri-Implantitis: A Pilot Clinical Study

The aim of this pilot, exploratory, single blind clinical trial is to evaluate the epigenetic changes associated with peri-implantitis.

Read the detailed description

Twenty patients will be voluntarily enrolled in two groups: 10 healthy participants, and 10 participants with peri-implantitis. Periodontal and peri-implant clinical and radiographic measurements, as well as body mass index, medical and dental history will be recorded within the following timelines: at baseline (for both groups), and 6 months after baseline for the peri-implantitis group only. At baseline, gingival biopsies and blood will be harvested from: a) healthy gingival sites during either surgical removal of wisdom teeth or gingivoplasty, in the healthy group; and, b) from a peri-implantitis site during surgical treatment of peri-implantitis, and when possible, from a healthy gingival site within the same participant, in the peri-implantitis group. After harvesting of biopsies, peri-implantitis subjects will be re-evaluated 6 months after treatment. During the 6-month visit, if a second surgical treatment of peri-implantitis in the same implant treated at baseline is indicated as standard of care of the participant, a new gingiva biopsy and blood will be collected. Gingival biopsies and blood collected from each participant will be used to perform DNA methylation analysis.

Conditions
Periimplantitis
Being tested
Gingival biopsy and blood sample collection
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gingival biopsy and blood sample collectionProcedure or surgery

    Gingival and blood samples will be collected.

Study groups in NCT03753464
Study groupRoleWhat they receive
Peri-implantitisPatients undergoing surgical treatment for peri-implantitis. Gingival and blood samples will be collected during the treatment for peri-implantitis.
Receives: Procedure: Gingival biopsy and blood sample collection
HealthyHealthy patients undergoing treatment for either wisdom tooth extraction or gingivectomy. Gingival and blood samples will be collected during either wisdom tooth extraction or gingivectomy.
Receives: Procedure: Gingival biopsy and blood sample collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in epigenetic signatures in peri-implantitis subjects as compared to healthy subjects, in an exploratory manner. (Gingival biopsies and blood collected to perform DNA methylation analysis)

    Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis will be used to determinate epigenetic signatures associated with peri-implantitis.

    Measured: 6 months

  2. Epigenetic signatures associated with response to treatment peri-implantitis at 6 months, in an exploratory manner. (Differences in epigenetic signatures in peri-implantitis subjects as compared to healthy subjects, in an exploratory manner.

    Samples collected from patients with peri-implantitis will be used to determinate epigenetic signatures associated response to treatment peri-implantitis at 6 months. (Gingival biopsies and blood collected to perform DNA methylation analysis)

    Measured: 6 months

Secondary outcomes (9)

  1. Visual Analog Scale (VAS) will be assessed to determinate patient-reported outcome measures, at baseline and at 6 months.

    A visual analog scale (VAS) will be used to evaluate patient's pain/discomfort, esthetic satisfaction, and the subjects' overall satisfaction at baseline and at 6 months.

    Measured: 6 months

  2. Oral Health Impact Profile-14 (OHIP-14) will be assessed to determinate patient-reported outcome measures, at baseline and at 6 months.

    Oral Health Impact Profile-14 (OHIP-14) assessed at baseline and at 6 months.

    Measured: 6 months

  3. Changes in peri-implant pocket depths (PPD) (in mm) from baseline to 6 month after surgery (only peri-implantitis group).

    Peri-implant pocket depths (PPD) will be assessed at baseline and 6 month after surgery.

    Measured: 6 months

  4. Changes in peri-implant BOP (in percentage), from baseline to 6 month after surgery (only peri-implantitis group).

    Peri-implant BOP (in percentage) will be assessed at baseline and 6 month after surgery.

    Measured: 6 months

  5. Percentage of peri-implant pocket closure at to 6 month after surgery (only peri-implantitis group).

    Percentage of peri-implant pocket closure will be assessed at at to 6 month after surgery.

    Measured: 6 months

  6. Changes in peri-implant marginal bone level (in mm) from baseline to 6 month after surgery (only peri-implantitis group).

    Mean crestal bone level change around the implants will be determined by periapical radiographs of mesial and distal bone levels from baseline to 6 months surgery.

    Measured: 6 months

  7. Change in soft tissue levels (in mm) from baseline to 6 month after surgery (only peri-implantitis group).

    Soft tissue levels assessed at baseline and 6 months post-surgery in implants with peri-implantitis.

    Measured: 6 months

  8. Incidence of post-operative surgical site infections (only peri-implantitis group).

    Number of post-operative surgical site infections from surgery to 6 months.

    Measured: 6 months

  9. Incidence of post-operative complications (only peri-implantitis group).

    Number of post-operative complications from surgery to 6 months.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2018
  2. Study start4 Oct 2018
  3. Primary completion2 Jul 2019
  4. Study completion2 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03753464
Sponsor's protocol ID
18-00986
Status last verified
Jul 2024
First submitted
15 Nov 2018
Last updated
3 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Periimplantitis, run by NYU College of Dentistry at 1 site 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 13 inclusion and 23 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Differences in epigenetic signatures in peri-implantitis subjects as compared to healthy subjects, in an exploratory manner. (Gingival biopsies and blood collected to perform DNA methylation analysis) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT03753464.

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 3 Jul 2024.

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