NCT05964127

Brief Summary

To investigate the effects of peri-implantitis (a disease around dental implants) and its treatment at both local and systemic levels using clinical and biological parameters. One study with two parts which will run simultaneously. An initial observational study comparing cases and controls and a subsequent interventional study in which the cases will proceed to treatments and all participants will be followed up for 6 months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 11, 2020

Completed
2.6 years until next milestone

Study Start

First participant enrolled

July 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

December 11, 2020

Last Update Submit

July 19, 2023

Conditions

Peri-Implantitis and Systemic Inflammation

Outcome Measures

Primary Outcomes (1)

  • Inflammation

    Serum CRP

    6-months after treatment

Secondary Outcomes (5)

  • Inflammation

    Baseline, 3 and 6-months after treatment

  • Endothelial Function

    Baseline, 3 and 6 months after treatment

  • OCT

    Baseline, 3 and 6 months after treatment

  • Blood flow

    Baseline, 3 and 6 months

  • Gingival tissue thickness

    Baseline, 3 and 6 months after treatment

Study Arms (3)

Group A - Non-surgical hand instruments

ACTIVE COMPARATOR

After appropriate local anaesthesia of the treatment site supragingival, subgingival and implant surface debridement will be undertaken with Hu-Friedy titanium implant hand instruments only. Any remaining supragingival deposits will be polished using a contra-angle handpiece, rubber cup and Cleanic polishing paste.

Other: Hand instruments

Group B - Non-surgical Air-flow

ACTIVE COMPARATOR

After appropriate local anaesthesia of the treatment site supragingival, subgingival and implant surface debridement will be undertaken using EMS PerioFlow with Plus powder (Erythritol) and supplemented with EMS Piezon and EMS AirFlow and Plus powder as required.

Device: Air flow device

Group C - Surgical Air-flow

ACTIVE COMPARATOR

After appropriate local anaesthesia of the treatment site a full thickness mucoperiosteal flap will be raised to adequately expose the tissue defect. Supragingival, subgingival and implant surface debridement will be undertaken using EMS PerioFlow with Plus powder (Erythritol) and supplemented with EMS Piezon and EMS AirFlow and Plus powder as required.

Device: Air flow deviceProcedure: Access flap surgery

Interventions

Air flow deviceDEVICE

An air/powder device for surface decontamination

Group B - Non-surgical Air-flowGroup C - Surgical Air-flow
Hand instrumentsOTHER

Periodontal hand instruments

Group A - Non-surgical hand instruments
Access flap surgeryPROCEDURE

To improve the surgical access for implant decontamination

Group C - Surgical Air-flow

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age and in good general health
  • A minimum of 20 teeth
  • Participants must have at least one implant in situ with peri-implantitis as per its case definition
  • Must voluntarily agree to sign the consent form

You may not qualify if:

  • Currently on any weight reduction program
  • History of diabetes
  • Uncontrolled or currently undergoing treatment for systemic medical conditions
  • Chronic treatment (defined as 2 weeks or more) of antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline assessment
  • Taking statins drugs
  • History of alcohol or drug abuse
  • Self-reported pregnancy or breastfeeding
  • Patients who have active periodontitis as per its case definition and/or have had treatment for periodontitis within the last 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Jeanie Suvan

CONTACT

+442034561108j.suvan@ucl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Head of Department of Periodontology

Study Record Dates

First Submitted

December 11, 2020

First Posted

July 27, 2023

Study Start

July 19, 2023

Primary Completion

July 31, 2025

Study Completion

December 31, 2025

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

GB(1)