Association of Implant Position and Crown Contour With Tissue Health

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05644470
Collaborator
(none)
122
1
36
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 [Patient Registry]
    Anticipated Enrollment :
    122 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Association of Implant Position and Crown Contour With Esthetics and Tissue Health in Anterior Single Tooth Replacement: a Prospective Study
    Actual Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    Sep 30, 2025
    Anticipated Study Completion Date :
    Sep 30, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Dental implant rehabilitation

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University Shanghai Shanghai China 200011

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Maurizio Tonetti, DMD, Shanghai Ninth People Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Maurizio Tonetti, Chief professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    ClinicalTrials.gov Identifier:
    NCT05644470
    Other Study ID Numbers:
    • SH9H-2022-T296
    First Posted:
    Dec 9, 2022
    Last Update Posted:
    Dec 9, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maurizio Tonetti, Chief professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    Study Results

    No Results Posted as of Dec 9, 2022