Dental ImplantsNCT07909629
Association Between Peri-implant Tissue Health and Crown Shape: a Prospective Study
An observational study of Dental Implants, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants
- What is being tested?
- Because this is an observational study, no treatment is assigned by the investigators for research purposes.
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age greater than 18 years.
- Presence of a single implant-supported restoration.
- Implant placement performed according to a Type 3 or Type 4 timing protocol following tooth extraction.
- Presence of natural teeth adjacent to the implant site on both the mesial and distal sides.
- Willingness to participate in the scheduled follow-up assessments.
- Ability and willingness to provide written informed consent.
Who cannot join
- Pregnancy or plans to become pregnant during the study period.
- Presence of a disease or medical condition considered unsuitable for dental implant treatment.
- Unwillingness to provide written informed consent.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Dental Implants
- Being tested
- Because this is an observational study, no treatment is assigned by the investigators for research purposes.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Because this is an observational study, no treatment is assigned by the investigators for research purposes.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-Tooth Implant Restoration Cohort | 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. Receives: Other: Because this is an observational study, no treatment is assigned by the investigators for research purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909629
- Sponsor's protocol ID
- SH9H2026-T669
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Peri-implant Tissue Health and Crown Shape: a Prospective Study
- ClinicalTrials.gov ID
- NCT07909629
- Acronym / sponsor ID
- SH9H2026-T669
- Conditions
- Dental Implants
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Tooth Implant Restoration Cohort | – | Other: Because this is an observational study, no treatment is assigned by the investigators for research purposes.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Age greater than 18 years.
- Presence of a single implant-supported restoration.
- Implant placement performed according to a Type 3 or Type 4 timing protocol following tooth extraction.
- Presence of natural teeth adjacent to the implant site on both the mesial and distal sides.
- Willingness to participate in the scheduled follow-up assessments.
Key exclusion criteria (3 listed)
- Pregnancy or plans to become pregnant during the study period.
- Presence of a disease or medical condition considered unsuitable for dental implant treatment.
- Unwillingness to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Single-Tooth Implant Restoration Cohort |
Primary outcome
Peri-implant Bleeding on Probing
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
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.
6 secondary outcomes
Peri-implant Probing Depth
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Peri-implant Crevicular Fluid Inflammatory Biomarker Levels
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Subgingival Microbial Composition
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Marginal Bone Level Change
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Buccal Peri-implant Soft-Tissue Height Change
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Interdental Papilla Height Change
Time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant Bleeding on Probing (time frame: Approximately 6 months, 1 year, 2 years, and 3 years after definitive restoration placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.