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Unilateral Attachment Versus Tooth Implant Supported Bridge

Primary Purpose

Edentulous Jaw

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

attachment

bridge

CONVENTIONAL

About this trial

This is an interventional other trial for Edentulous Jaw focused on measuring attachment,, patient satisfaction, radiographic evaluation, implant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Unilateral mandibular distal extension area
The abutments showed sufficient occluso-gingival height of its clinical crown
Adequate inter-arch space and no tempro-mandibular joint disorders.
No para-functional habits,
Full opposing arch or restored with acceptable fixed restoration
Minimal bone height11 mm at the lower second molar area.

Exclusion Criteria:

*Insufficent bone height in posterior area of mandible

Sites / Locations

Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

conventional group

attachment group

tooth implant supporeted prosthesis

Arm Description

conventional partial denture

unlateral attachment retained partial denture

tooth implant supported bridge

Outcomes

Primary Outcome Measures

patient satisfaction

questionnaires

Secondary Outcome Measures

biting force

measuring the biting force of the patients by sensor

radiographic evaluation

evaluation of alveolar bone loss

Full Information

NCT ID

NCT04301115

First Posted

March 2, 2020

Last Updated

March 6, 2020

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04301115

Brief Title

Unilateral Attachment Versus Tooth Implant Supported Bridge

Official Title

Attachment-retained Unilateral Partial Denture Versus Tooth Implant Supported Prosthesis in Mandibular Distal Extension Cases

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

February 1, 2018 (Actual)

Primary Completion Date

September 20, 2019 (Actual)

Study Completion Date

October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Purpose: Evaluation of patients' satisfaction, biting force measurement and radiographic evaluation of abutment teeth of tooth implant supported bridge, unilateral attachment and conventional partial denture in mandibular distal extension cases. Materials and methods: Twenty four patients were selected and divided into three equal groups, each of eight patients: patients of group I Patients received a fixed tooth implant supported bridge, patients of group II Patients received a removable unilateral attachment partial denture and group III Patients received a conventional removable partial denture.Evaluation included patient satisfaction and biting force measurement radiographic evaluation of terminal abutments.

Detailed Description

Purpose: Evaluation of patients' satisfaction, biting force measurement and radiographic evaluation of abutment teeth of tooth implant supported bridge, unilateral attachment and conventional partial denture in mandibular distal extension cases. Materials and methods: Twenty four patients were selected according to the following criteria: Patients with unilateral mandibular distal extension with last standing second premolar abutment, abutments showed sufficient occluso-gingival height and good periodontal condition. Patients were divided into three equal groups, each of eight patients: patients of group I Patients received a fixed tooth implant supported bridge, patients of group II Patients received a removable unilateral attachment partial denture and group III Patients received a conventional removable partial denture.Evaluation included patient satisfaction using "OHIP14" questionnaires and biting force measurement radiographic evaluation of terminal abutments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edentulous Jaw

Keywords

attachment,, patient satisfaction, radiographic evaluation, implant

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

conventional group

Arm Type

Active Comparator

Arm Description

conventional partial denture

Arm Title

attachment group

Arm Type

Experimental

Arm Description

unlateral attachment retained partial denture

Arm Title

tooth implant supporeted prosthesis

Arm Type

Experimental

Arm Description

tooth implant supported bridge

Intervention Type

Other

Intervention Name(s)

attachment

Intervention Description

unilateral attachment from rehine 83

Intervention Type

Other

Intervention Name(s)

bridge

Intervention Description

tooth implant supported bridge

Intervention Type

Other

Intervention Name(s)

CONVENTIONAL

Other Intervention Name(s)

partial denture

Intervention Description

conventional metalic partial denture

Primary Outcome Measure Information:

Title

patient satisfaction

Description

questionnaires

Time Frame

1 month

Secondary Outcome Measure Information:

Title

biting force

Description

measuring the biting force of the patients by sensor

Time Frame

1 month

Title

radiographic evaluation

Description

evaluation of alveolar bone loss

Time Frame

1 month

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Unilateral mandibular distal extension area The abutments showed sufficient occluso-gingival height of its clinical crown Adequate inter-arch space and no tempro-mandibular joint disorders. No para-functional habits, Full opposing arch or restored with acceptable fixed restoration Minimal bone height11 mm at the lower second molar area. Exclusion Criteria: *Insufficent bone height in posterior area of mandible

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

samira Ibrahim, prof

Organizational Affiliation

professor of prosthodontics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cairo University

City

Cairo

ZIP/Postal Code

11511

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

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Unilateral Attachment Versus Tooth Implant Supported Bridge

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