Association of Implant Position and Crown Contour With Tissue Health

Dental Implants Clinical Trial

Official title:

Association of Implant Position and Crown Contour With Esthetics and Tissue Health in Anterior Single Tooth Replacement: a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644470
• Other study ID #: SH9H-2022-T296
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Xinyu WU
• Phone: 0086 13971172285
• Email: wuxinyu_dentist[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implants

Locations

Country	Name	City	State
China	Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Changes over six months, 1, 2, and 3 years after final crown insertion.
Secondary	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.	Changes over six months, 1, 2, and 3 years after final crown insertion.
Secondary	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.	Chenges over Six months, 1, 2, and 3 years after final crown insertion.
Secondary	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.	Changes over six months, 1, 2, and 3 years after final crown insertion.
Secondary	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.	Changes over six months, 1, 2, and 3 years after final crown insertion.