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Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Fourth Military Medical University
Sponsor:
Information provided by (Responsible Party):
Ji-hua Chen, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT02850458
First received: July 25, 2016
Last updated: July 29, 2016
Last verified: July 2016
  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 Fourth Military Medical University:

Primary Outcome Measures:
  • Survival of implants [ Time Frame: through study completion, an average of 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gingival Bleeding on Probing [ Time Frame: through study completion, an average of 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Pocket depths measured around implants in millimeter (mm)

  • Marginal bone loss [ Time Frame: through study completion, an average of 1 year ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • patients' satisfaction [ Time Frame: through study completion, an average of 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: September 2016
Estimated Primary Completion Date: August 2016 (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

Ages Eligible for Study:   45 Years to 83 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: July 25, 2016
Last Updated: July 29, 2016
Health Authority: China: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Yes

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

ClinicalTrials.gov processed this record on August 22, 2016