NCT04751565

Brief Summary

This study is designed to compare the resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

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

February 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

February 6, 2021

Last Update Submit

February 24, 2023

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (1)

  • Bleeding on Probing (BOP) changes

    Changes over time in BOP changes (percentage)

    Baseline (T0), 3-months (T1) and at 6-months (T2)

Secondary Outcomes (1)

  • Full mouth plaque score (FMPS) changes

    Baseline (T0), 3-months (T1) and at 6-months (T2)

Other Outcomes (2)

  • Pocket probing depth (PD) mm changes

    Baseline (T0), 3-months (T1) and at 6-months (T2)

  • Presence of plaque at implant sites according to plaque index (PlI)

    Baseline (T0), 3-months (T1) and at 6-months (T2)

Study Arms (2)

Tissue level implant Group

EXPERIMENTAL

Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with tissue level implant Primary outcome The primary outcome will be based on probing depth (PD)

Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy

Bone level implant Group

EXPERIMENTAL

Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with bone level implant Primary outcome The primary outcome will be the change in Bleeding on Probing (BOP) (Lang, Joss, Orsanic, Gusberti, Siegrist, 1986).

Other: Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy

Interventions

Bleeding on Probing change reduction following peri-implant mucositis non surgical therapyOTHER

Statistically significant different in terms of Bleeding on Probing will be recorded between groups.

Bone level implant GroupTissue level implant Group

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female aged \> 18 years
  • TL and BL titanium implants with smooth necks supporting cemented or screw-retained single-unit crowns diagnosed with PM (Berglundh, et al.,2018)
  • Implants placed in both arches
  • Patients with gingivitis or treated periodontitis (i.e., absence of residual PD \> 5 mm)
  • Presence of at least 2 mm of keratinized mucosa at implant sites.

You may not qualify if:

  • presence of medical conditions contraindicating treatment of peri-implant mucositis,
  • regular use of anti-inflammatory drugs or antibiotics within 3 months prior to study enrollment
  • Presence of systemic diseases
  • Pregnant and lactating females
  • Smokers \> 10 cigarettes/day
  • Use of inflammatory drugs or antibiotics within 3 months prior to study recruitment
  • Implants with modified (i.e. micro-rough) necks
  • Interproximal open contacts between implant restoration and adjacent teeth
  • Peri-implantitis (Renvert, et al., 2018)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Messina

Messina, 98100, Italy

Location

Study Officials

  • Gaetano Isola

    Università degli Studi di Mesina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Compare resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 6, 2021

First Posted

February 12, 2021

Study Start

February 1, 2021

Primary Completion

December 15, 2021

Study Completion

December 20, 2021

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Sharing study results

Shared Documents
STUDY PROTOCOL
Time Frame
6-months
Access Criteria
Pubmed website

Locations

IT(1)