PeriImplant Soft Tissue and Marginal Bone Loss of Single Implant Mandibular Overdenture

NCT ID: NCT02881905

Last Updated: 2016-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-07-31

Brief Summary

There is a significant difference between CM LOC and ball attachment, when considering the peri-implant soft tissue health and marginal bone loss. The primary and secondary objectives are to determine if CM LOC attachment improves the peri-implant soft tissue response and decreases the marginal bone loss around implant when compared to conventional ball attachment

Detailed Description

Ball attachments are very commonly used because they are solitary, simple, easier to use and less technique sensitive if compared to bar attachments. However, ball attachment require a prosthetic space of 12 mm and could show tremendous wear if implants were mal-aligned. CM LOC attachment is newly introduced into market with very good expectations regarding its properties and effect on the periimplant soft tissue. CM LOC attachment, which combes titanium patrix and resin matrix made from polyetherketoneketone (PEKK), is a very promising material regarding the wear and the prosthesis retention it provides, even with mal-aligned implants. However, the clinical performance of this attachment was not tested yet. Therefore, in this randomized controlled trial it was decided to compare between CM LOC and the commonly used ball attachment regarding the soft tissue health and marginal bone loss.

Conditions

Complete Edentulism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ball attachment

completely edentulous patients having single median mandibular implant to retain mandibular overdenture.the attachment used is the conventional ball attachment

Group Type: ACTIVE_COMPARATOR

ball attachment

Intervention Type: DEVICE

it is attachment part that connects the overdenture to the implant

CM LOC attachment

completely edentulous patients having single median mandibular implant to retain mandibular overdenture.the attachment used is the cm loc attachment

Group Type: EXPERIMENTAL

cm loc attachment

Intervention Type: DEVICE

It is a new attachment made of peek material

Interventions

ball attachment

it is attachment part that connects the overdenture to the implant

Intervention Type: DEVICE

cm loc attachment

It is a new attachment made of peek material

Intervention Type: DEVICE

Other Intervention Names

metallic ball attachment

Eligibility Criteria

Inclusion Criteria

• Completely edentulous male or female patients between the ages of 50 to 69.
• No contraindications for implantation.
• Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetic patients (90-130 fasting according to American Association of Diabetes) will be included.
• Sufficient bone width (≥ 6 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
• Residual bone height ranging from 11-20 mm with the lowest vertical height in the midline of the mandible not less than 13 mm (Class II or III according to McGarry et al[16] 1999). This will be confirmed by the CBCT.
• Patients seeking to install a single symphyseal implant and for whom new dentures will be constructed.
• Patients, who are dissatisfied with the retention and stability of their technically satisfactory dentures.
• Patients, who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, it is found that there are technical problems with regard to denture design and/or occlusion; then new maxillary and mandibular dentures will be fabricated
• All patients should have adapted to their dentures for at least six weeks before being included in the trial.
• Patients providing written informed consents to participate in the trial and this will be done before the scheduled date for implant installation.

Exclusion Criteria

• Patients with a systemic or local contra-indication for implant placement.
• Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture.
• Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (as measured by a caliper) or with 12 mm crown height space as measured by a ruler from the incisal edge till the crest of the ridge. This will be done from a putty index of the diagnostic set up.
• Incompliant and not cooperative patients.
• Patients smoking more than 10 cigarettes per day.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kiel

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Salah Hamed Sherif

associate lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nouran abdelnaby, phd

Role: STUDY_DIRECTOR

prosthodontic department-faculty of dentistry-cairo university

Locations

Outpatient Clinic-Prosthodontic Department-Faculty of Dentistry-Cairo University

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

ahmed sherif, Msc

Role: CONTACT

ahmed.sherif@dentistry.cu.edu.eg

00201002130130

Hassan ahmed

Role: CONTACT

Hassan.ahmed@dentistry.cu.edu.eg

0020105009014

Facility Contacts

nouran abdelnaby, phd

Role: primary

nouran.abdelnaby@dentistry.cu.edu.eg

00201001539310

Role: backup

dentmail@dentistry.cu.edu.eg

00223642938

Other Identifiers

CEBD-CU-2016-8-179

Identifier Type: -

Identifier Source: org_study_id