NCT02950662

Brief Summary

The aim of this study is to compare the clinical effect of PEEK housing vs. metal housing in terms of retention and patient satisfaction

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

October 25, 2016

Last Update Submit

October 31, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Retention of implant supported overdenture by using digital force meter device

    3 months

Study Arms (2)

Metal housing

ACTIVE COMPARATOR

metal housing of ball and socket attachment the intervention will be overdenture

Other: Overdenture

Peek housing

ACTIVE COMPARATOR

Peek housing of ball and socket attachment the intervention will be overdenture

Other: Overdenture

Interventions

Active comparator will be metal housing and peek housing

Also known as: Implant supported overdenture
Metal housingPeek housing

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient should be free from any systemic disease that may interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension, blood diseases, bone diseases, smoking.etc.
  • Patients have completely edentulous upper and lower arches.
  • Patients have healthy mucosa free from any ulceration, inflammation or infections.
  • All patients are free from neuromuscular and temporomandibular joint disorders.
  • Selected patients have normal maxillo-mandibular relationship (Angle class I ridge classification) with adequate inter-arch space and normal tongue size.

You may not qualify if:

  • Patients with limited manual dexterity.
  • Patients with Xerostomia, excessive salivation or pathological mucosal changes (e.g. Lichen planus, Leukoplakia…etc.)
  • Pregnant females.
  • Un co-operative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Denture, Overlay

Intervention Hierarchy (Ancestors)

DenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2016

First Posted

November 1, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Last Updated

November 1, 2016

Record last verified: 2016-10