NCT03221803

Brief Summary

The purpose of this study aimed to answer a clinical question whether In a patient with bilateral distal extension area, would the metal framework partial denture with OT vertical attachment versus partial denture with OT CAP attachment result in better patient satisfaction?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Status
unknown

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

First Submitted

Initial submission to the registry

July 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

July 17, 2017

Last Update Submit

July 17, 2017

Conditions

Patient SatisfactionBone Changes

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction assessed using questionnaire

    Questionnaire for patient satisfaction

    9 months

Secondary Outcomes (2)

  • bone height

    9 months

  • bone density

    9 months

Study Arms (2)

OT Vertical attachment

EXPERIMENTAL

The attachment consists of a male part that is in the form of a steady with a central hole. This part is attached to the abutments .the female component is a white standard retentive clip engaging the outer walls of a steady male. It is incorporated in the partial denture together with a castable balancing pin that fits into the central hole of the steady male and aids in centering the prosthesis during the final stage of insertion; thereby ensuring a longer life to the retentive clips.

Other: OT Vertical attachment

OT Cap attachment

ACTIVE COMPARATOR

Beveled castable bar with micro-size sphere located in first molar region, and attached to the distal surface of the waxed crowns to be cast as one piece, Nylone caps of standard retention for micro size sphere this nylon caps fit onto their spheres and located in metal housing at fitting surface on the denture and Positioning rings to maintain the space for nylon cap during construction of the partial denture metal framework.

Other: OT cap attachment

Interventions

OT Vertical attachmentOTHER

new extra coronal castable attachment

Also known as: Castable twin cylinder attachment
OT Vertical attachment
OT cap attachmentOTHER

standard extra coronal attachment

Also known as: extra coronal castable attachment
OT Cap attachment

Eligibility Criteria

Age35 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients age ranged between 35-45years old.
  • All patients have Kennedy class I partially edentulous mandibular arch in which the last remaining teeth were the second premolars bilaterally.
  • The abutment teeth had an apparently good periodontal condition with no signs of mobility or inflammation with firm and healthy mucosa.
  • Edentulous ridge covered by health firm mucoperiosteum, without abnormal bony irregularity or severe lingual undercuts.
  • Patients with normal relationship of maxilla and mandible (Angle class I ridge classification) and sufficient inter-arch space (6mm) the size of the attachment
  • The opposing dentition is intact arch with no noticeable over eruption or tilting or restored with acceptable fixed restoration.
  • All patients are free from neurological, muscular disorders and tempro-mandibular joint disorders.
  • Only patients who can be easily motivated to achieve and maintain good oral

You may not qualify if:

  • Patient with limited skills
  • Un co-operative patients.
  • patient with bad oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Ahmed Hassaan, PHD

CONTACT

01021722944ahmedhassan871983@gmail.com

Yusr Mady

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at faculty of dentistry fayoum university

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 19, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

July 19, 2017

Record last verified: 2017-07