Association of Implant Position and Crown Contour With Tissue Health

NCT05644470 | Recruiting DMC

• 1 other identifier: SH9H-2022-T296
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dental Implants

Keywords

dental implants; emergence profile; crown contour

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Changes over six months, 1, 2, and 3 years after final crown insertion.

• Changes in composition of microbiome in sub-gingival plaque sample

  Changes over six months, 1, 2, and 3 years after final crown insertion.

• Marginal bone level change

  Chenges over Six months, 1, 2, and 3 years after final crown insertion.

• Buccal soft tissue level change

  Changes over six months, 1, 2, and 3 years after final crown insertion.

• Papilla height change

  Changes over six months, 1, 2, and 3 years after final crown insertion.

Study Arms (1)

Dental implant rehabilitation

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 28985447 BACKGROUND

• Yi 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.

  PMID: 31912511 BACKGROUND

• Chan 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.

  PMID: 30638273 BACKGROUND

• Tonetti 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.

  PMID: 31215112 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peri-implant crevicular fluid will be collected to analyze the inflammatory cytokine. Sub-mucosal plaque will be collected to analyze the composition of microbiome.

Study Officials

• Maurizio Tonetti, DMD

  Shanghai Ninth People Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyu WU

CONTACT

0086 13971172285; wuxinyu_dentist@hotmail.com

Maurizio Tonetti, DMD

CONTACT

008615000102368; maurizio.tonetti@ergoperio.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief professor

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 9, 2022
• Study Start: October 1, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)