Dental ImplantsNCT05644470
Association of Implant Position and Crown Contour With Tissue Health
An observational study of Dental Implants, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Sep 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200011
Xinyu Wu, +86 21 13971172285, wuxinyu_dentist@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Implants
- Keywords
- dental implants, emergence profile, crown contour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Changes in bleeding on probing
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.
Measured: Changes over six months, 1, 2, and 3 years after final crown insertion.
Secondary outcomes (5)
Changes in cytokine level in peri-implant crevicular fluid
Peri-implant crevicular fluid will be collected and level of inflammatory cytokines will be analyzed using commercial enzyme-linked immunosorbent assays (ELISAs) kits.
Measured: Changes over six months, 1, 2, and 3 years after final crown insertion.
Changes in composition of microbiome in sub-gingival plaque sample
Sub-gingival plaque sample will be collected. Composition of microbiome in sub-gingival plaque samples will be assessed by 16sRNA technique.
Measured: Changes over six months, 1, 2, and 3 years after final crown insertion.
Marginal bone level change
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.
Measured: Chenges over Six months, 1, 2, and 3 years after final crown insertion.
Buccal soft tissue level change
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.
Measured: Changes over six months, 1, 2, and 3 years after final crown insertion.
Papilla height change
Intra-oral scan taken at different follow-up time points will be superimposed. Papilla height will be recorded and the change will be measured.
Measured: Changes over six months, 1, 2, and 3 years after final crown insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Oct 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 122 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Tonetti, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Maurizio Tonetti, DMD, Principal investigator, Shanghai Ninth People Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644470
- Sponsor's protocol ID
- SH9H-2022-T296
- Status last verified
- Apr 2024
- First submitted
- 26 Nov 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katafuchi M, Weinstein BF, Leroux BG, Chen YW, Daubert DM. Restoration contour is a risk indicator for peri-implantitis: A cross-sectional radiographic analysis. J Clin Periodontol. 2018 Feb;45(2):225-232. doi: 10.1111/jcpe.12829. Epub 2017 Dec 5.
PubMed 28985447Yi Y, Koo KT, Schwarz F, Ben Amara H, Heo SJ. Association of prosthetic features and peri-implantitis: A cross-sectional study. J Clin Periodontol. 2020 Mar;47(3):392-403. doi: 10.1111/jcpe.13251. Epub 2020 Jan 21.
PubMed 31912511Chan D, Pelekos G, Ho D, Cortellini P, Tonetti MS. The depth of the implant mucosal tunnel modifies the development and resolution of experimental peri-implant mucositis: A case-control study. J Clin Periodontol. 2019 Feb;46(2):248-255. doi: 10.1111/jcpe.13066. Epub 2019 Feb 7.
PubMed 30638273Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.
PubMed 31215112
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Implant Position and Crown Contour With Esthetics and Tissue Health in Anterior Single Tooth Replacement: a Prospective Study
- ClinicalTrials.gov ID
- NCT05644470
- Acronym / sponsor ID
- SH9H-2022-T296
- Conditions
- Dental Implants
- Keywords
- dental implants, emergence profile, crown contour
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 9 Dec 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental implant rehabilitation | – | –Patients having undergone dental implant treatment, with a single implant-supported restoration in anterior jaws (premolars to premolars), will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Changes in cytokine level in peri-implant crevicular fluid
Time frame: 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.
Marginal bone level change
Time frame: 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.
Papilla height change
Time frame: Changes over six months, 1, 2, and 3 years after final crown insertion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 28985447Katafuchi M, Weinstein BF, Leroux BG, Chen YW, Daubert DM. Restoration contour is a risk indicator for peri-implantitis: A cross-sectional radiographic analysis. J Clin Periodontol. 2018 Feb;45(2):225-232. doi: 10.1111/jcpe.12829. Epub 2017 Dec 5.
- Background: PubMed 31912511Yi Y, Koo KT, Schwarz F, Ben Amara H, Heo SJ. Association of prosthetic features and peri-implantitis: A cross-sectional study. J Clin Periodontol. 2020 Mar;47(3):392-403. doi: 10.1111/jcpe.13251. Epub 2020 Jan 21.
- Background: PubMed 30638273Chan D, Pelekos G, Ho D, Cortellini P, Tonetti MS. The depth of the implant mucosal tunnel modifies the development and resolution of experimental peri-implant mucositis: A case-control study. J Clin Periodontol. 2019 Feb;46(2):248-255. doi: 10.1111/jcpe.13066. Epub 2019 Feb 7.
- Background: PubMed 31215112Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Maurizio Tonetti, DMD principal investigator
Shanghai Ninth People Hospital
1 site in 1 country: see every site and its status.
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 at 1 site in China.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinyu WU (0086 13971172285, wuxinyu_dentist@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in bleeding on probing (time frame: Changes over six months, 1, 2, and 3 years after final crown insertion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05644470, which also lists 4 linked publications.
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 17 Apr 2024.