(PEEK) Housing Verses Metallic Housing of Ball and Socket Attachment on Retention of Mandibular Overdenture

Problem With Dentures Clinical Trial

Official title:

Effect of Polyether Ether Ketone (PEEK) Housing Verses Metallic Housing of Ball and Socket Attachment on Retention of Mandibular Implant Retained Overdentures: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02950662
• Other study ID #: cebd-cu-2016-10-230
• Status: Not yet recruiting
• Phase: N/A
• First received: October 25, 2016
• Last updated: October 31, 2016
• Start date: October 2016

Study information

• Verified date: October 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Patients have completely edentulous upper and lower arches.

3. Patients have healthy mucosa free from any ulceration, inflammation or infections.

4. All patients are free from neuromuscular and temporomandibular joint disorders.

5. Selected patients have normal maxillo-mandibular relationship (Angle class I ridge classification) with adequate inter-arch space and normal tongue size.

Exclusion Criteria:

1. Patients with limited manual dexterity.

2. Patients with Xerostomia, excessive salivation or pathological mucosal changes (e.g. Lichen planus, Leukoplakia…etc.)

3. Pregnant females.

4. Un co-operative patients.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Problem With Dentures

Intervention

Other:
• Overdenture
Active comparator will be metal housing and peek housing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention of implant supported overdenture by using digital force meter device		3 months	Yes