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

NCT02881905 | Unknown

• 1 other identifier: CEBD-CU-2016-8-179
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Complete Edentulism

Outcome Measures

Primary Outcomes (1)

• Soft tissue reaction :Presence of mucositis

  it is a binary outcome that is measured by either its presence or absence

  [from baseline up to 1 year]

Secondary Outcomes (4)

• Modified gingival Index

  from baseline up to 1 year. score measurement from 0-4 where 0 is no inflammation and 4 is severe inflammation

• Modified Plaque Index

  from baseline upto 1 year. score measurement from 0-3 where 0 denotes no plaque present and 3 denotes abundant plaque

• Modified Bleeding Index

  from baseline upto 1 year. score from 0-3 where 0 denotes no bleeding and 3 denotes profound bleeding

• marginal bone loss

  from baseline up to 1 year

Study Arms (2)

ball attachment

ACTIVE COMPARATOR

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

Device: ball attachment

CM LOC attachment

EXPERIMENTAL

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

Device: cm loc attachment

Interventions

ball attachment DEVICE

it is attachment part that connects the overdenture to the implant

Also known as: metallic ball attachment

ball attachment

cm loc attachment DEVICE

It is a new attachment made of peek material

CM LOC attachment

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• University of Kiel: collaborator

Study Sites (1)

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

Giza, Egypt

RECRUITING

Study Officials

• nouran abdelnaby, phd

  prosthodontic department-faculty of dentistry-cairo university

  STUDY DIRECTOR

Central Study Contacts

ahmed sherif, Msc

CONTACT

00201002130130; ahmed.sherif@dentistry.cu.edu.eg

Hassan ahmed

CONTACT

0020105009014; Hassan.ahmed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate lecturer

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 29, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2021
• Last Updated: September 12, 2016

Record last verified: 2016-09

Locations

EG (1)