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Oral Health Related Quality of Life and Peri-implant Condition in Single Implant Overdenture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02861313
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : September 4, 2019
Information provided by (Responsible Party):
Marwa Abdelaal Mohammed, Cairo University

Brief Summary:
Comparing the quality of life and periimplant condition around a single implant retained mandibular overdenture in two groups one will have a ball attachment and the other is having a (CM-LOC) one.

Condition or disease Intervention/treatment Phase
Quality of Life Implant Device: CM LOC attachment Device: ball attachment Not Applicable

Detailed Description:

Single implant retained mandibular overdenture is considered an economic and simple treatment modality for edentulous subjects. Resin matrix (CM LOC) is one of the low profile attachments which represent a promising retention values with subsequent improvement in chewing ability and in turns enhance patient quality of life.Oral health impact profile for edentulous patient (OHIP-EDENT) is more specific to edentulous subjects.

Peri-implant soft tissue health (bleeding, inflammation, etc...) is a valuable marker to implant success. The study will record different attachment influenced-tissue response and its relation to implant success and oral health related quality of life (OHRQOL)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Health Related Quality of Life and Peri-implant Condition in Single Implant Mandibular Overdenture Retained by CM LOC Versus Ball Attachment: A Randomized Controlled Trial
Actual Study Start Date : January 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: CM LOC attachment
CM LOC attachment other names: resin matrix attachment
Device: CM LOC attachment
CM LOC attachment
Other Name: resin matrix attachment

Active Comparator: ball attachment
ball attachment other names metallic ball attachment
Device: ball attachment
Ball attachment
Other Name: metallic ball attachment

Primary Outcome Measures :
  1. change in oral health related quality of life using (oral health impact profile edentulous) questionnaire (OHIP-EDENT) [ Time Frame: from baseline up to 5 years ]
    likert scale from 0-4

Secondary Outcome Measures :
  1. change in modified gingival index [ Time Frame: from baseline up to 5 years ]
    score measurement from 0-4 where 0 is no inflammation and 4 is sever inflammation

  2. change in plaque index [ Time Frame: from baseline up to 5 years ]
    score measurement from 0-3 where 0 denotes absence of plaque, 3 abundant plaque

  3. modified bleeding index [ Time Frame: from baseline up to 5 years ]
    score measurement from 0-3 where 0 denotes no bleeding, 3 profuse bleeding

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02861313

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Removable Prosthodontic Department, Faculty of Oral and Dental Medicine - Cairo University
Cairo, Egypt, +02
Sponsors and Collaborators
Cairo University
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Principal Investigator: marwa AA mohammed, A lecturer non affliated
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Responsible Party: Marwa Abdelaal Mohammed, Assisstant Lecturer, Cairo University Identifier: NCT02861313    
Other Study ID Numbers: CEBD-CU-2016-07-175
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided