Non-surgical Treatment of Peri-implant Mucositis

May 16, 2022 updated by: Istituto Ortopedico Galeazzi

Non-surgical Treatment of Peri-implant Mucositis: A Randomized Controlled Clinical Trial Comparing Standard Treatment and Comprehensive Treatment

This a Randomized Controlled Clinical Trial comparing two techniques for the nonsurgical treatment of peri-implant mucositis. The main objective of the present randomized controlled clinical trial is to determine whether the application of a novel treatment strategy for peri-implant mucositis could lead to significantly improved clinical parameters as compared to standard treatment. Half of the patients receives treatment with manual instruments and chlorhexidine gel 1%, half receives treatment with submucosal biofilm removal by erythritol powder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20161
        • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects should have at least one implant (Renvert et al. 2009),
  • with bleeding on probing using a 0.2N probing force or spontaneous bleeding with local swelling (code 1, 2 or 3 as described in Corbella et al. 2011) and with bone resorption of no more of 1 mm (preferably no bone loss visible on radiographs) as evaluated through the use of standardized radiographs, taken with the use of an individualized radiograph holder in comparison with findings from radiographs taken immediately following placement of the implant prosthesis (similar to Renvert et al. 2009 and Algraffee et al. 2011).
  • females and males 35 to 65 years old; (IV) full mouth bleeding score % lower than 20%.

Exclusion Criteria:

  • systemic diseases that could affect the immune response or that could condition the bacterial colonization
  • use of anti-inflammatory prescription medications, or antibiotics within the preceding respectively 1 week and 3 months or during the study,
  • full-mouth plaque score (FMPS) >20%;
  • full-mouth bleeding score (FMBS) >20%,
  • smokers of more than 5 cigarettes a day,
  • Documented allergy or intolerance towards the components of the products used in the study,
  • Presence of active infection with suppuration.
  • Absence of periodontitis in the rest of the mouth
  • Pregnancy (certified by auto-declaration)
  • Patients suffering from upper respiratory tract infections, from chronic bronchitis
  • endocarditis, breast feeding, contagious disease, immune deficiency (neutropenia, angranulocytosis, diabetes, hemophilia), patients under treatment (radiotherapy, chemotherapy, antibiotics).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard treatment
Manual treatment One application of Chlorhexidine 1% gel
Drug: Chlorhexidine
Chlorhexidine gel 1% one single application after mechanical biofilm removal through manual instruments
Experimental: Comprehensive treatment
Supragingival biofilm removal with Erythritol air-powder Submucosal biofilm removal with Erythritol air-powder (30%-60% power)
Device: Air-powder
Erythritol powder using air-powder device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bleeding index change
Time Frame: 3 months
The primary outcome measure is the change in bleeding index between the baseline and the follow-up visit, on the basis of the following index: 0) no bleeding; 1) bleeding on probing without redness and swelling; 2) bleeding on probing, redness and swelling; and 3) spontaneous bleeding.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PPD changes
Time Frame: 2 weeks, 1 month, 3, 6, 12, 24 months
Changes in peri-implant probing depth between baseline and follow-up visit
2 weeks, 1 month, 3, 6, 12, 24 months
Tissue level changes
Time Frame: 2 weeks, 1 month, 3, 6, 12, 24 months
Changes in tissue level between baseline and follow-up visit, measured as the distance between a reference point on an occlusal personalized stent, made with polyvinylsiloxane impression material, and the mucosal margin
2 weeks, 1 month, 3, 6, 12, 24 months
PI changes
Time Frame: 2 weeks, 1 month, 3, 6, 12, 24 months
Changes in plaque index between baseline and follow-up visit on the basis of the following indeX: 0) no plaque accumulation; 1) plaque accumulation only detectable using a probe; 2) moderate accumulation of visible plaque/ calculus; 3) high accumulation of visible plaque/calculus.)
2 weeks, 1 month, 3, 6, 12, 24 months
BI changes
Time Frame: 2 weeks, 1 month, 6, 12, 24 months
The primary outcome measure is the change in bleeding index between the baseline and the follow-up visit, on the basis of the following index: 0) no bleeding; 1) bleeding on probing without redness and swelling; 2) bleeding on probing, redness and swelling; and 3) spontaneous bleeding.
2 weeks, 1 month, 6, 12, 24 months
Marginal bone level changes
Time Frame: 6 and 12 months
Changes in radiographic marginal bone level between baseline and follow-up visit measured comparing the periapical radiograph (with individualized holder) taken during baseline visit and the ones taken 6 and 12 months after intervention.
6 and 12 months
Pain perception: Visual Analogue Scale
Time Frame: Immediately after intervention
Pain perception during intervention, measured with a 10-mm long Visual Analogue Scale scale being 0 equal to no pain and 10 equal to maximum, unbearable, pain. Lower values represent better outcome.
Immediately after intervention
Limitations in daily activity
Time Frame: 7 days
Limitations in daily activity measured with a 10-mm long VAS scale being 0 equal to no limitation and 10 equal to complete limitation in daily activity, recorded daily. Lower values represent better outcome.
7 days
Taste alteration
Time Frame: 7 days
Alteration in taste measured with a 10-mm long VAS scale being 0 equal to no alteration and 10 equal to complete taste alteration, recorded daily. Lower values represent better outcome.
7 days
Taste sensation
Time Frame: 7 days
Taste sensation measured with a 10-mm long VAS scale being 0 equal to no sensation and 10 equal to revolting taste sensation, recorded daily. Lower values represent better outcome.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSTPM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators planned to share anonymized IPD after the end of the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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