NCT02867982

Brief Summary

This is a two-year prospective randomized clinical study to to evaluate whether the gingival thickness and insertion depth of dental implants have any influence on marginal bone levels changes around platform switched implants.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

3.4 years

First QC Date

July 24, 2016

Last Update Submit

August 13, 2016

Conditions

EdentulousBone Resorption

Keywords

platform switchingcrestal bone remodelingsoft tissue thicknessdental implant

Outcome Measures

Primary Outcomes (1)

  • Changes of marginal bone levels of dental implant

    Mesial and distal marginal bone level alterations at different time point compared with the base line. Marginal bone levels were measured with an image analysis software to the accuracy of 0.01 mm and the implant length is used as calibration for the measurement.

    3 months, 6 months, 1 year and 2 years post intervention (implant surgery)

Secondary Outcomes (3)

  • Bleeding on probing(BOP)

    3 months, 6 months, 1 year and 2 years post intervention (implant surgery)

  • Probing pocket depth(PPD)

    3 months, 6 months, 1 year and 2 years post intervention (implant surgery)

  • modified plaque index(PI)

    3 months, 6 months, 1 year and 2 years post intervention (implant surgery)

Study Arms (2)

Subcrestal

OTHER

implants that are placed below the alveolar ridge

Procedure: Subcrestal implant placementDrug: prophylactic antibioticsDevice: dental implantRadiation: x-ray examination

Paracrestal

OTHER

implants that are placed flush to the alveolar ridge

Procedure: Paracrestal implant placementDrug: prophylactic antibioticsDevice: dental implantRadiation: x-ray examination

Interventions

Subcrestal implant placementPROCEDURE

Dental implants placed 2 mm below the alveolar ridge

Subcrestal
Paracrestal implant placementPROCEDURE

Dental implants placed flush to the alveolar ridge

Paracrestal
prophylactic antibioticsDRUG

amoxicillin was used before and after implant surgery for prophylactic reasons

ParacrestalSubcrestal
dental implantDEVICE

dental implants (Ankylos® system,Dentsply Implants Manufacturing GmbH, Mannheim, Germany) were surgically placed into the edentulous alveolar ridge

ParacrestalSubcrestal
x-ray examinationRADIATION

radiographies were taken before treatment and at different time point during the follow-up period

ParacrestalSubcrestal

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lose of two posterior teeth more than 3 months
  • generally healthy (ASA score I)
  • non-smoking
  • periodontally healthy
  • sufficient bone volume to place an implant without augmentation procedure

You may not qualify if:

  • medical and/or psychiatric contraindication to dental implant restoration
  • local infection
  • pregnancy or lactating
  • poor oral hygiene
  • tissue deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mouth, EdentulousBone Resorption

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Xi Jiang, DMD

    Peking University school and hospital of stomotology, Department of oral implantology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 24, 2016

First Posted

August 16, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

August 16, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share