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Completed

NCT Number: NCT02861313

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

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.

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Key information

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Removable Prosthodontic Department, Faculty of Oral and Dental Medicine - Cairo University

Cairo, +02, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM LOC attachment

Device

CM LOC attachment

Other names: resin matrix attachment

ball attachment

Device

Ball attachment

Other names: metallic ball attachment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 10, 2016
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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