Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients

• Conditions: Edentulous
• Interventions: Device: implant-retained overdentures

• Registration Number: NCT02850458
• Lead Sponsor: Ji-hua Chen

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-01
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Last Update Submitted: 2017-02-04
• Last Update Posted: 2017-02-07
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
implant retained-overdentures with the attachment of bar	implant-retained overdentures	patients treated with implant-retained overdentures,and the attachment is bar
implant retained-overdentures with the attachment of magnet	implant-retained overdentures	patients treated with implant-retained overdentures,and the attachment is magnet

Primary Outcome Measures

Name	Time	Method
Survival of implants	through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Gingival Bleeding on Probing	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
Marginal bone loss	through study completion, an average of 1 year
Pocket depths	through study completion, an average of 1 year	Pocket depths measured around implants in millimeter (mm)

Trial Locations

Locations (1)

Stomatological Hospital of Fourth Military Medical University; 🇨🇳 Xi'an, Shanxi, China