NCT04301115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

March 2, 2020

Last Update Submit

March 6, 2020

Conditions

Edentulous Jaw

Keywords

attachment,patient satisfactionradiographic evaluationimplant

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction

    questionnaires

    1 month

Secondary Outcomes (2)

  • biting force

    1 month

  • radiographic evaluation

    1 month

Study Arms (3)

conventional group

ACTIVE COMPARATOR

conventional partial denture

Other: CONVENTIONAL

attachment group

EXPERIMENTAL

unlateral attachment retained partial denture

Other: attachment

tooth implant supporeted prosthesis

EXPERIMENTAL

tooth implant supported bridge

Other: bridge

Interventions

attachmentOTHER

unilateral attachment from rehine 83

attachment group
bridgeOTHER

tooth implant supported bridge

tooth implant supporeted prosthesis
CONVENTIONALOTHER

conventional metalic partial denture

Also known as: partial denture
conventional group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \*Insufficent bone height in posterior area of mandible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11511, Egypt

Location

MeSH Terms

Conditions

Jaw, EdentulousPatient Satisfaction

Interventions

Congresses as TopicDenture, Partial

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and OrganizationsDenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Officials

  • samira Ibrahim, prof

    professor of prosthodontics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of prosthodontics

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 10, 2020

Study Start

February 1, 2018

Primary Completion

September 20, 2019

Study Completion

October 1, 2019

Last Updated

March 10, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)