Association of Implant Position and Crown Contour With Tissue Health

Recruiting

• Conditions: Dental Implants

• Registration Number: NCT05644470
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

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 Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-11-26
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in bleeding on probing	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.

Secondary Outcome Measures

Name	Time	Method
Changes in cytokine level in peri-implant crevicular fluid	Changes over six months, 1, 2, and 3 years after final crown insertion.	Peri-implant crevicular fluid will be collected and level of inflammatory cytokines will be analyzed using commercial enzyme-linked immunosorbent assays (ELISAs) kits.
Changes in composition of microbiome in sub-gingival plaque sample	Changes over six months, 1, 2, and 3 years after final crown insertion.	Sub-gingival plaque sample will be collected. Composition of microbiome in sub-gingival plaque samples will be assessed by 16sRNA technique.
Marginal bone level change	Chenges over Six months, 1, 2, and 3 years after final crown insertion.	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.
Buccal soft tissue level change	Changes over six months, 1, 2, and 3 years after final crown insertion.	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.
Papilla height change	Changes over six months, 1, 2, and 3 years after final crown insertion.	Intra-oral scan taken at different follow-up time points will be superimposed. Papilla height will be recorded and the change will be measured.

Trial Locations

Locations (1)

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