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Trial record 3 of 3116 for:    retain

Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients

This study is currently recruiting participants.
Verified February 2017 by Ji-hua Chen, Fourth Military Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02850458
First Posted: August 1, 2016
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ji-hua Chen, Fourth Military Medical University
  Purpose
The purpose of this study is to evaluate the clinical results of implant-retained mandibular overdentures in edentulous patients.

Condition Intervention
Edentulous Device: implant-retained overdentures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients: A 5-year Retrospective Study

Further study details as provided by Ji-hua Chen, Fourth Military Medical University:

Primary Outcome Measures:
  • Survival of implants [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures:
  • Gingival Bleeding on Probing [ Time Frame: through study completion, an average of 1 year ]
    Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding

  • Pocket depths [ Time Frame: through study completion, an average of 1 year ]
    Pocket depths measured around implants in millimeter (mm)

  • Marginal bone loss [ Time Frame: through study completion, an average of 1 year ]

Other Outcome Measures:
  • patients' satisfaction [ Time Frame: through study completion, an average of 1 year ]
    patients' satisfaction were assessed on visual analog scales (VAS)

  • oral health-related quality of life [ Time Frame: through study completion, an average of 1 year ]
    Patients completed a 14-item Oral Health Impact Profile (OHIP-14) to assess oral health-related quality of life


Estimated Enrollment: 54
Study Start Date: February 2016
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
implant retained-overdentures with the attachment of bar
patients treated with implant-retained overdentures,and the attachment is bar
Device: implant-retained overdentures
patients treated with an implant-retained overdenture in the mandible
implant retained-overdentures with the attachment of magnet
patients treated with implant-retained overdentures,and the attachment is magnet
Device: implant-retained overdentures
patients treated with an implant-retained overdenture in the mandible

Detailed Description:
The survival of implants,condition of the peri-implant soft tissue were evaluated. And patients' perceptions regarding the outcome were assessed on visual analog scales (VAS), oral health impact profile-14 (OHIP) and semantic differential scale questionnaires.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 83 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients treated with implant retained overdentures at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University between July 2011 to May 2014.
Criteria

Inclusion Criteria:

  1. Patients treated with implant retained overdentures
  2. With the ability to read and sign the informed consent document

Exclusion Criteria:

  1. Jaw radiotherapy treatment before and after implanting
  2. Patients who suffered with mental and psychological disease will influence their oral health normal maintenance
  3. Can not read and sign the informed consent document
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850458


Contacts
Contact: Ji hua chen, PhD 029-84776329 hchen@fmmu.edu.cn

Locations
China, Shanxi
Stomatological Hospital of Fourth Military Medical University Recruiting
Xi'an, Shanxi, China
Contact: ji hua chen, PhD    029-84776329    jhchen@fmmu.edu.cn   
Contact: huan zhou    029-84776128    zhouhuan113@126.com   
Sponsors and Collaborators
Ji-hua Chen
Investigators
Principal Investigator: Yong jin chen IRB of Stomatological Hospital of FMMU,PLA
  More Information

Responsible Party: Ji-hua Chen, Professor and Dean of the Department of Prosthodontics, School of Stomatology, Fourth Military Medical University, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02850458     History of Changes
Other Study ID Numbers: IRB-REV-2016036
First Submitted: July 25, 2016
First Posted: August 1, 2016
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases