Patient Satisfaction and Bone Changes for OT Cap and OT Vertical Attachment

Patient Satisfaction and Bone Changes in Bilateral Distal Extension Case Using OT Cap Versus OT Vertical Attachment "Randomized Clinical Trial"

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?

Study Overview

• Status: Unknown
• Conditions: Patient Satisfaction; Bone Changes
• Intervention / Treatment: Other: OT Vertical attachment; Other: OT cap attachment

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OT Vertical attachment; 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; new extra coronal castable attachment; Other Names: Castable twin cylinder attachment
Active Comparator: OT Cap attachment; 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; standard extra coronal attachment; Other Names: extra coronal castable attachment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction assessed using questionnaire	Questionnaire for patient satisfaction	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone height	radio graphically by digora	9 months
bone density	radio graphically by digora	9 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: OT Cap_OT Vertical

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No