Association of Implant Position and Crown Contour With Esthetics and Tissue Health in Anterior Single Tooth Replacement: a Prospective Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Changes in bleeding on probing
Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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.)
Investigators
Maurizio Tonetti
Chief professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University