An observational study in Dental Implants, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Observational
This prospective cohort study aims to investigate the associations between the morphology of single-tooth implant-supported restorations, implant-related local factors, and peri-implant tissue health.
Participants receiving a single implant-supported restoration will undergo routine clinical follow-up. Peri-implant clinical parameters, supragingival and subgingival plaque, peri-implant crevicular fluid, intraoral scans, and periapical radiographs will be collected during routine follow-up visits.
The study will evaluate whether factors including implant three-dimensional position, restoration emergence profile, emergence angle, mucosal tunnel depth, restoration retention type, abutment type, and patient-related factors are associated with peri-implant inflammation, microbiological composition, marginal bone level, and peri-implant soft tissue changes.
The primary hypothesis is that deviation between the actual implant position and the digitally planned ideal implant position, as well as prosthetic emergence morphology, may be associated with peri-implant inflammation and changes in the local microbiome.
This is a prospective observational cohort study of patients receiving single-tooth implant-supported restorations at Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine.
All implant treatment and follow-up procedures are performed as part of routine clinical care. Participation in the study does not require additional invasive treatment or additional clinical visits beyond routine implant follow-up.
Patients are enrolled approximately 6 months after placement of the definitive implant-supported restoration if they meet the eligibility criteria.
Clinical and demographic information collected includes age, sex, smoking and alcohol use, medical history, medication use, implant site, implant system and dimensions, implant placement protocol, use of guided or navigated surgery, soft- and hard-tissue augmentation, healing protocol, restoration retention type, abutment type, and restoration material.
At approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement, participants undergo peri-implant probing, plaque assessment, intraoral scanning, collection of subgingival plaque and peri-implant crevicular fluid, standardized periapical radiography, assessment of complications, and oral health-related quality-of-life evaluation.
Peri-implant crevicular fluid will be analyzed for inflammatory mediators including IL-1β, IL-6, TNF-α, MIP-1α, MMP-8, and MMP-9. Subgingival plaque composition will be evaluated using 16S rRNA-based microbial analysis.
Digital imaging will be used to characterize implant three-dimensional position, emergence profile, emergence angle, mucosal tunnel depth, marginal bone level, buccal soft-tissue height, and papillary height.
Associations between implant-, restoration-, patient-, and site-related factors and peri-implant clinical, inflammatory, microbiological, radiographic, and soft-tissue outcomes will be assessed using descriptive statistics, correlation analyses, multivariable or regression analyses, and exploratory cluster or principal component analyses.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.
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Patients treated at the Department of Oral Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, who receive a single implant-supported restoration and attend routine clinical follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults receiving a single implant-supported restoration with natural teeth adjacent on both the mesial and distal sides. Participants receive routine implant treatment and are prospectively followed to evaluate associations between implant/restoration characteristics and peri-implant tissue health.
Other: Because this is an observational study, no treatment is assigned by the investigators for research purposes.
Observed implant- and restoration-related characteristics include three-dimensional implant position, emergence profile, emergence angle, mucosal tunnel depth, restoration retention type, abutment type, implant design, and use of guided or navigated implant surgery. These characteristics are not assigned by the research protocol.
Peri-implant Bleeding on Probing
Bleeding on probing will be assessed during peri-implant probing using a periodontal probe. Peri-implant probing is performed at six sites around each implant-supported restoration: mesiobuccal, mid-buccal, distobuccal, mesiolingual/palatal, mid-lingual/palatal, and distolingual/palatal sites. Bleeding following probing will be recorded and used as an indicator of peri-implant soft-tissue inflammation.
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Peri-implant Probing Depth
Probing depth is measured from the peri-implant soft-tissue margin to the bottom of the sulcus using a UNC-15 periodontal probe with approximately 0.25-g probing force at six sites around each implant.
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Peri-implant Crevicular Fluid Inflammatory Biomarker Levels
Levels of IL-1β, IL-6, TNF-α, MIP-1α, MMP-8, and MMP-9 in peri-implant crevicular fluid will be quantified using ELISA.
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Subgingival Microbial Composition
Subgingival plaque samples collected from peri-implant sites will be analyzed using 16S rRNA-based methods to characterize microbial composition.
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Marginal Bone Level Change
Marginal bone level will be measured on standardized parallel periapical radiographs. The most coronal implant-to-bone contact will be used to define the marginal bone level, and longitudinal changes will be assessed.
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Buccal Peri-implant Soft-Tissue Height Change
Serial intraoral scans from the same participant will be superimposed to quantify changes in buccal peri-implant soft-tissue height.
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Interdental Papilla Height Change
Serial intraoral scans will be superimposed to measure longitudinal changes in peri-implant papillary height.
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University →