Predictive Value of Reduced Keratinized Mucosa on the Secondary Prevention of Peri-implant Mucositis and Periimplantitis in Patients Attending Regular Supportive Peri-implant Care. A Longitudinal Analysis

April 6, 2023 updated by: Hannover Medical School
  • Capture of the potential risk factor "lack of band of keratinised mucosa" over a period of up to 5 years.
  • Recording of peri-implant inflammatory processes in study participants that are not recorded during normal tooth cleaning
  • Registration of the extent of radiographic bone loss. Bone resorption through analysis of existing X-ray images
  • Individual therapy recommendation/individual supportive peri-implant care in case of peri-implant inflammation
  • The present study was specifically designed to investigate the effect of reduced width of keratinized mucosa (KM) on the secondary prevention of peri-implant mucositis and peri-implantitis in patients attending a supportive peri-implant care program (SPIC) over an observation period of up to five years.

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.

Detailed Description

Patient information such as age, gender, history of periodontitis, edentulism, previous oral and maxillofacial tumor with a history of head and neck radiation, smoking habits, and metabolic diseases like diabetes mellitus were collected. Implant-specific information such as bone augmentation, year of implantation, implant position, implant level (bone level, tissue level), and number of implants were also documented. Prosthetic factors like the type of prosthesis (single crown, bridge construction, telescope prosthesis) and the type of attachment (cemented, screwed) were recorded. Clinical examination and measurement of clinical parameters were subsequently performed, including probing depth (PD) at six implant sites using a graduated periodontal probe, bleeding on probing or suppuration (BoP/Sup) occurring within 30 seconds after probing, and recessions measured in mm using a graduated periodontal probe between a defined clinical reference point and the implant mucosa.Participants were motivated to undergo regular SPIC, with frequency based on their individual risk factors. Patients without increased risk were encouraged to attend a 6-month recall. If bleeding or suppuration occurred, the frequency of SPIC was increased to monthly controls with oral hygiene instruction and plaque removal. Peri-implantitis therapy was initiated in patients with radiographically detectable bone loss, followed by lifelong SPIC. The modified plaque index (mPl) and full mouth plaque score API were used to assess local plaque accumulation and compliance. The modified gingival index (mGI) was used to assess the inflammatory state of the soft tissue. The mucositis severity score (MSS) was used to investigate the initiation and progression of peri-implant mucositis, with scores ≥18 indicating advanced inflammation. KM impact on MSS values <8 and ≥18 was investigated. Periodontal screening index (PSI) was used to classify the general periodontal condition of the patients by dividing the dentition into sextants. The width of the KM mucogingival junction was assessed using the "rolling technique." Radiographs were analyzed using byzznxt to diagnose possible radiological bone resorption. An individual diagnosis was made for each implant at the end of the examination, and data was collected following a standardized operating procedure and saved electronically.

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.
Observational

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.
104

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

  • Germany
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover (MHH)

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

104 patients with at least one root-shaped dental implant who took part in one of the previous studies and who were attending supportive peri-implant care (SPIC) at the Department of Prosthetic Dentistry and Biomedical Materials Science of Hannover Medical School were asked to participate in the study.

Description

Inclusion Criteria:

- Patients aged at least 18 years who have at least one root-form dental implant in situ and were part of the first (DOI10.1111/clr.13432) and/or the second (DOI 10.1007/s00784-020-03422-1) observational study

Exclusion Criteria:

  • Systemic antibiotic use up to 3 months before the examination
  • pregnancy
  • lactating mothers

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
General population (i)
All participants of the study, including any periodontal condition.
Diagnostic test: Measurement of implant parameters
  1. Examination of the inclusion criteria
  2. Medical history/patient-specific data (smoking, tumour diseases, radiation, gender, number of implants, history of periodontitis).
  3. Recording of implant-specific parameters (measurement depth at six sites per implant(probing depth/PD), bleeding and or pus on probing (BOP) at six measurement sites per implant, condition of the peri-implant mucosa using the modified plaque index(mPI) and the modified ginigiva index (mGI), measurement of the width of the keratinised mucosa(KM), type of denture, approximal plaque index (API), radiographically detectable bone resorption.
Periodontally healthy patients with history of periodontitis (ii)
Patients whose current periodontal condition is healthy but who have developed periodontitis in the past.
Diagnostic test: Measurement of implant parameters
  1. Examination of the inclusion criteria
  2. Medical history/patient-specific data (smoking, tumour diseases, radiation, gender, number of implants, history of periodontitis).
  3. Recording of implant-specific parameters (measurement depth at six sites per implant(probing depth/PD), bleeding and or pus on probing (BOP) at six measurement sites per implant, condition of the peri-implant mucosa using the modified plaque index(mPI) and the modified ginigiva index (mGI), measurement of the width of the keratinised mucosa(KM), type of denture, approximal plaque index (API), radiographically detectable bone resorption.
Periodontally healthy patients without history of periodontitis (iii)
Patients whose current periodontal condition is healthy, who have also not had periodontitis in the past.
Diagnostic test: Measurement of implant parameters
  1. Examination of the inclusion criteria
  2. Medical history/patient-specific data (smoking, tumour diseases, radiation, gender, number of implants, history of periodontitis).
  3. Recording of implant-specific parameters (measurement depth at six sites per implant(probing depth/PD), bleeding and or pus on probing (BOP) at six measurement sites per implant, condition of the peri-implant mucosa using the modified plaque index(mPI) and the modified ginigiva index (mGI), measurement of the width of the keratinised mucosa(KM), type of denture, approximal plaque index (API), radiographically detectable bone resorption.

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
Protective value of keratinized mucosa around dental implants in periodontal healthy patients
Time Frame: Up to five years
Keratinized mucosa is a significant protective factor for the progression of peri-implant mucositis to severe peri-implant mucositis and to peri-implantitis in patients without history of periodontitis attending regular SPIC over a period of up to five years.
Up to five years

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
Mucositis severity score (MSS) related to the supported peri implant care (SPIC)
Time Frame: Up to five years
  1. The MSS ≤6 is a reasonable cut-off to define the endpoint of peri-implantitis treatment, define the entrance of the patient into SPIC and is an indicator for a successful SPIC program.
  2. MSS scores 7-17 indicate an elevated risk of disease progression and support the clinicians in decision making on reevaluating frequency and protocol of the patients individual SPIC.
  3. MSS scores ≥18 indicate that SPIC is not enough and (non-) surgical peri-implantitis treatment should be considered.
Up to five years

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.
Hannover Medical School

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.
February 12, 2020

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.
October 23, 2020

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.
December 17, 2020

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).
March 27, 2023

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 6, 2023

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 7, 2023

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.
April 7, 2023

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.
April 6, 2023

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.
March 1, 2023

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.
  • 9228_BO_S_2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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