Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients

Edentulous Clinical Trial

Official title:

Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients: A 5-year Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02850458
• Other study ID #: IRB-REV-2016036
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2016
• Last updated: February 4, 2017
• Start date: February 2016
• Est. completion date: August 2017

Study information

• Verified date: February 2017
• Source: Fourth Military Medical University
• Contact: Ji hua chen, PhD
• Phone: 029-84776329
• Email: hchen[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the clinical results of implant-retained mandibular overdentures in edentulous patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: August 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 83 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulous
• Mouth, Edentulous

Intervention

Device:
• implant-retained overdentures
patients treated with an implant-retained overdenture in the mandible

Locations

Country	Name	City	State
China	Stomatological Hospital of Fourth Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Ji-hua Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patients' satisfaction	patients' satisfaction were assessed on visual analog scales (VAS)	through study completion, an average of 1 year
Other	oral health-related quality of life	Patients completed a 14-item Oral Health Impact Profile (OHIP-14) to assess oral health-related quality of life	through study completion, an average of 1 year
Primary	Survival of implants		through study completion, an average of 1 year
Secondary	Gingival Bleeding on Probing	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	through study completion, an average of 1 year
Secondary	Pocket depths	Pocket depths measured around implants in millimeter (mm)	through study completion, an average of 1 year
Secondary	Marginal bone loss		through study completion, an average of 1 year