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

Recruiting

Conditions

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

Observational

Enrollment (Estimated)

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 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

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
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

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

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

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

Investigators

  • 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)

October 1, 2022

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

November 26, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID 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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