Association of Implant Position and Crown Contour With Tissue Health

April 16, 2024 updated by: Maurizio Tonetti, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Association of Implant Position and Crown Contour With Esthetics and Tissue Health in Anterior Single Tooth Replacement: a Prospective Study

Emergence profile and crown contour of implant supported rehabilitation, which is influenced by implant position, is associated with peri-implant health and esthetic outcomes. However, there is no study prospectively explore the association between implant position, emergence profile/crown contour, and dental implant outcomes. Thus, the present study aims to (1) assess the multivariate association between local factors and peri-implant soft-tissue health, inflammation, and microbiome; and (2) to identify patterns/clusters of implant characteristics significantly associated with health or inflammation.

Study Overview

Status

Status

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

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.

Detailed Description

This will be a prospective study aimed at associating the development of peri-implant mucosal inflammation (mucositis) and deeper inflammation (peri-implantitis with marginal bone loss) with features associated with implant position (three-dimensional position of the implant platform) and the consequent shape of the crown contour and emergence profile. The hypothesis is that implant position determines the shape of the crown, which in turn determines the persistence of a local microbial biofilm as unfavourable crown contours hamper oral hygiene efforts aimed at biofilm control/removal. The persistence of a biofilm will cause soft tissue inflammation, which may lead to microbial dysbiosis and disease.

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 (Estimated)

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.
122

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
        • Contact:

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

Sampling Method

Non-Probability Sample

Study Population

Patients will have undergone pre-surgery examination (including CBCT and intra-oral scan) received dental implant treatment in Department of Oral Implantology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. Timing of implant placement will be type 3/4. Patients will have one single implant supported rehabilitation in anterior jaws (premolar to premolar), with adjacent natural teeth.

Description

Inclusion Criteria:

Patients with a single implant-supported restoration in anterior jaws (premolars to premolars), with adjacent natural teeth, with pre-surgery CBCT and intra-oral scans, and willing to comply with research appointments/schedule.

Exclusion Criteria:

  • Pregnancy or intention to become pregnant at any point during the study duration;
  • With any systematic diseases/conditions that are contradictions to dental implant treatment;
  • Inability or unwillingness of individual to give written informed consent.
  • Inability of follow-up according to the protocol.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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.
Dental implant rehabilitation
Patients having undergone dental implant treatment, with a single implant-supported restoration in anterior jaws (premolars to premolars), will be included.

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
Changes in bleeding on probing
Time Frame: Changes over six months, 1, 2, and 3 years after final crown insertion.
Peri-implant probing will be performed with light (∼25 g) force using UNC-15 periodontal probe, at six sites (mesio- buccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual) per implant. At each site, presence of bleeding will be recorded.
Changes over six months, 1, 2, and 3 years after final crown insertion.

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
Changes in cytokine level in peri-implant crevicular fluid
Time Frame: Changes over six months, 1, 2, and 3 years after final crown insertion.
Peri-implant crevicular fluid will be collected and level of inflammatory cytokines will be analyzed using commercial enzyme-linked immunosorbent assays (ELISAs) kits.
Changes over six months, 1, 2, and 3 years after final crown insertion.
Changes in composition of microbiome in sub-gingival plaque sample
Time Frame: Changes over six months, 1, 2, and 3 years after final crown insertion.
Sub-gingival plaque sample will be collected. Composition of microbiome in sub-gingival plaque samples will be assessed by 16sRNA technique.
Changes over six months, 1, 2, and 3 years after final crown insertion.
Marginal bone level change
Time Frame: Chenges over Six months, 1, 2, and 3 years after final crown insertion.
Marginal bone level change will be measured on periapical radiograph using parallel technique. The uppermost end of bone-to-implant contact will be recorded as marginal bone level. Implant will be used as reference.
Chenges over Six months, 1, 2, and 3 years after final crown insertion.
Buccal soft tissue level change
Time Frame: Changes over six months, 1, 2, and 3 years after final crown insertion.
Intra-oral scan taken at different follow-up time points will be superimposed. Buccal soft tissue level will be recorded and the change will be measured.
Changes over six months, 1, 2, and 3 years after final crown insertion.
Papilla height change
Time Frame: Changes over six months, 1, 2, and 3 years after final crown insertion.
Intra-oral scan taken at different follow-up time points will be superimposed. Papilla height will be recorded and the change will be measured.
Changes over six months, 1, 2, and 3 years after final crown insertion.

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.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maurizio Tonetti, DMD, Shanghai Ninth People Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
October 1, 2022

Primary Completion (Estimated)

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.
September 30, 2025

Study Completion (Estimated)

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.
September 30, 2025

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).
November 26, 2022

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.
December 6, 2022

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.
December 9, 2022

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 17, 2024

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 16, 2024

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.
April 1, 2024

More Information

Terms related to this study

Keywords

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.
  • SH9H-2022-T296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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