search
Back to results

Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants

Primary Purpose

Peri-implant Mucositis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy
Sponsored by
University of Messina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peri-implant Mucositis

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • age ≥ 18 years
  • non-smokers and smokers ≤ 10 cigarettes/day
  • subjects with gingivitis or treated periodontal conditions (i.e., absence of residual PPD > 5 mm), peri-implant mucositis defined as ≥ 1 implant site with presence of BoP and absence of radiographic bone loss compared with a previous radiograph16 ,implant-supported fixed dental prostheses.

Exclusion criteria:

  • 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
  • pregnant or lactating females
  • removable implant-supported dental prostheses
  • prothesis reconstruction with visible gap between abutment and supra-structure,
  • peri-implantitis, defined as inflammation in the peri-implant mucosa with concomitant loss of supporting bone .

Sites / Locations

  • University of Messina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tissue level implant Group

Bone level implant Group

Arm Description

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)

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).

Outcomes

Primary Outcome Measures

Bleeding on Probing (BOP) changes
Changes over time in BOP changes (percentage)

Secondary Outcome Measures

Full mouth plaque score (FMPS) changes
Chenges in Full mouth plaque score (FMPS) (parameter)

Full Information

First Posted
February 6, 2021
Last Updated
February 24, 2023
Sponsor
University of Messina
search

1. Study Identification

Unique Protocol Identification Number
NCT04751565
Brief Title
Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants
Official Title
Analysis of the Treatment of Non-surgical Peri-implant Mucositis Treatment in Patients With Tissue-level (TL) and Bone-level (BL) Implants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Group A: Peri-implant mucositis (PM) at tissue-level (TL) implants after non-surgical mechanical debridement. Group B: Peri-implant mucositis (PM) bone-level (BL) implants after non-surgical mechanical debridement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tissue level implant Group
Arm Type
Experimental
Arm Description
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)
Arm Title
Bone level implant Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy
Intervention Description
Statistically significant different in terms of Bleeding on Probing will be recorded between groups.
Primary Outcome Measure Information:
Title
Bleeding on Probing (BOP) changes
Description
Changes over time in BOP changes (percentage)
Time Frame
Baseline (T0), 3-months (T1) and at 6-months (T2)
Secondary Outcome Measure Information:
Title
Full mouth plaque score (FMPS) changes
Description
Chenges in Full mouth plaque score (FMPS) (parameter)
Time Frame
Baseline (T0), 3-months (T1) and at 6-months (T2)
Other Pre-specified Outcome Measures:
Title
Pocket probing depth (PD) mm changes
Description
changes in Pocket probing depth (PD)
Time Frame
Baseline (T0), 3-months (T1) and at 6-months (T2)
Title
Presence of plaque at implant sites according to plaque index (PlI)
Description
Changes in presence of plaque at implant sites according to plaque index (PlI)
Time Frame
Baseline (T0), 3-months (T1) and at 6-months (T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
Università degli Studi di Mesina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Messina
City
Messina
ZIP/Postal Code
98100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Sharing study results
IPD Sharing Time Frame
6-months
IPD Sharing Access Criteria
Pubmed website

Learn more about this trial

Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants

We'll reach out to this number within 24 hrs