NCT06475313

Brief Summary

In this study, we collected and analysed the review results of 100 patients over 18 years of age who received implant fixed restorations in the Department of Stomatology of the First Hospital of Nanjing, China. The aim was to investigate the incidence of loss of contact between implant restorations and adjacent teeth and its influencing factors. Our findings may provide better insights for treatment planning and prevention of PCL.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

June 20, 2024

Last Update Submit

June 20, 2024

Conditions

Keywords

food impactionproximal contact lossImplant supported prosthesisDentition defectrisk factors

Outcome Measures

Primary Outcomes (1)

  • the proximal contact surface was adjusted by a dental floss (Reach waxed dental floss from Johnson & Johnson, standard thickness)

    The degree of proximal contact loss(PCL) was evaluated with a dental floss passing through the contact areas and classified as: (a) tight: sufficient resistance to the passage of the floss; (b) loose: insufficient resistance to the passage of the floss; and (c) open: contact: no resistance to the passage of the floss. The presence of an open or loose contact was classified as PCL.

    Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.

Secondary Outcomes (2)

  • oral panoramic radiograph

    Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.

  • Bausch Arti-Fol R metallic Shimstock-Film

    Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

One hundred consecutive patients, who had received either implant-supported fixed partial denture (FPD) or implant-supported single crown (SC) in the posterior region and were under regular review, were recruited.

You may qualify if:

  • (1) Patients over the age of 18, can fully understand the nature of the proposed and be able to sign a consent form.
  • (2) patients who underwent dental implant surgery and delivered prostheses for more than 3 months in Nanjing First Hospital.

You may not qualify if:

  • (1) The implant site or adjacent teeth were severely injured and the adjacent teeth were extracted;
  • (2) the same quadrant orthodontic or splint treatment;
  • (3) the prostheses have been removed due to failure or need further treatment;
  • (4) implant-supported prostheses in both mesial and distal sites;
  • (5) the adjacent teeth were directly or indirectly fixed with the implant-supported prosthesis;
  • (6) patients with missing clinical records of PD, PCR and BOP.
  • (7) The prosthetic prosthesis with implant-supported prosthesis was delivered for less than 3 months in Nanjing First Hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Location

Related Publications (4)

  • Yen JY, Kang L, Chou IC, Lai YL, Lee SY. Risk assessment of interproximal contact loss between implant-supported fixed prostheses and adjacent teeth: A retrospective radiographic study. J Prosthet Dent. 2022 Jan;127(1):86-92. doi: 10.1016/j.prosdent.2020.06.023. Epub 2020 Nov 7.

    PMID: 33172648BACKGROUND
  • Bompolaki D, Edmondson SA, Katancik JA. Interproximal contact loss between implant-supported restorations and adjacent natural teeth: A retrospective cross-sectional study of 83 restorations with an up to 10-year follow-up. J Prosthet Dent. 2022 Mar;127(3):418-424. doi: 10.1016/j.prosdent.2020.09.034. Epub 2020 Dec 17.

    PMID: 33342612BACKGROUND
  • Liang CH, Nien CY, Chen YL, Hsu KW. The prevalence and associated factors of proximal contact loss between implant restoration and adjacent tooth after function: A retrospective study. Clin Implant Dent Relat Res. 2020 Jun;22(3):351-358. doi: 10.1111/cid.12918. Epub 2020 May 17.

    PMID: 32419242BACKGROUND
  • Gasser TJW, Papageorgiou SN, Eliades T, Hammerle CHF, Thoma DS. Interproximal contact loss at implant sites: a retrospective clinical study with a 10-year follow-up. Clin Oral Implants Res. 2022 May;33(5):482-491. doi: 10.1111/clr.13908. Epub 2022 Mar 1.

    PMID: 35194854BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Interventions

short-wavelength opsinRadiation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Changao Xue, Master

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR
  • Ning Luo, Master

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR
  • Juan Lin, Master

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2024

First Posted

June 26, 2024

Study Start

July 1, 2024

Primary Completion

September 30, 2024

Study Completion

December 30, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Information about participants in this study will not be shared with investigators outside the study, and all study participants are identified by initials.

Locations