Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment

June 17, 2020 updated by: Hussein Hatam Jawad, Cairo University

Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment for Implant Retained Mandibular Over Denture Following Immediate Loading

  • Patients were randomly divided in to two groups by using computerized software ; the first group received flat magnetic attachment design while the second group received dome magnetic attachment design.which the inclusion criteria is completely edentulous patient ,Age range from 40 to 70 year old ,skeletal class 1, both sexes
  • Implant stability will be measured for both groups using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks.
  • Patient satisfaction measure in 2 weak and after 12 weak by Denture satisfaction questionnaire

Study Overview

Detailed Description

  • The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group flat magnetic attachment design and study group dome magnetic attachment design technique
  • Radiographic examination included a preoperative digital panoramic radiograph with 1:1 magnification for each patient as a primary survey to obtain an approximation of the available bone height and detect the presence of remaining roots and localized pathosis.
  • All patients will receive complete denture before implant installation .Constructed as the following
  • Primary impression to construct diagnostic cast and special tray .
  • Secondary impression with selective pressure impression technique to have master caste and occlusion block
  • Face bow transfer and centric relation record will be utilized to mount the master cast on semi adjuctable articulator ,then setting the teeth and trying the denture in patient mouth.
  • Processing of acrylic and lab remounting ,then delivery of the denture.
  • The complete denture will be duplication to be used as a guide to fabricate the radiographic stent after placement radio opaque marker in two lower canines then send patient to perform CBCT and these duplicate denture use as surgical template to place two implant.
  • CBCT machine: planmeca / CBCT soft ware : blue sky / FOV: single arch mandible /voxel size :400 Mm ( KV:90 / MA: 8 / S:11,997)
  • The CBCT examination where performed in radiology department / collage of dentistry /cairo university
  • serial follow up CBCT not need
  • Patients were randomly divided in to two groups by using computerized software ; the first group received flat magnetic attachment design while the second group received dome magnetic attachment design e. All surgeries were performed by the same prosthodontic.
  • All surgical procedures were performed under strict aseptic conditions, all patients received infiltration local anesthesia (Articaine 4% 1:100 000 epinephrine).
  • A crestal incision is made using No. 15 c blade extending over the crest of anterior mandible and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge for implant installed.
  • Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant in each group by the contra angle handpiece with special adaptor.(control and study groups)
  • The flap will then be closed using interrupted 4/0 resorbable sutures.
  • We connect magnetic attachment(flat,dome) for each groups on complete denture by pick up procedure at day of implant installation.
  • Relief space from the denture for the magnetic attachment will be made and a rubber dam will be used to closed the under cute under the magnetic attachment. pickup material will be added in the relief area to connect the housing to the denture intra orally.
  • Implant stability will be measured for both groups using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks.
  • Patient satisfaction measure in 2 weak and after 12 weak by Denture satisfaction questionnaire

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: runnd s zwain, bachelor
  • Phone Number: 01101034909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • completely edentulous patient.
  • Age range from 40 to 70 year old
  • Skeletal class 1
  • Both sexes.

Exclusion Criteria:

  • No intra oral soft and hard tissue pathology
  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Patient with sever parafunctional occlusal activity.
  • Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability,.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dome magnetic attachment
  • A crestal incision is made using No. 15 c blade extending over the crest of anterior mandible and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge for implant installed.
  • Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant in each group by the contra angle handpiece with special adaptor
  • We connect magnetic attachment(dome) for each groups on complete denture by pick up procedure at day of implant installation
  • All patients will receive complete denture before implant installation .
  • The CBCT examination should be take
  • patients received infiltration local anesthesia
  • A crestal incision is made using No. 15 c blade .
  • Full sequential drilling under copious saline irrigation will be made . insertion of two implant by the contra angle handpiece with special adaptor
  • We connect magnetic attachment(dome) on complete denture by pick up procedure at day of implant installation.
  • Implant stability will be measured using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks.
  • Patient satisfaction measure
Active Comparator: flat magnetic attachment
  • A crestal incision is made using No. 15 c blade extending over the crest of anterior mandible and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge for implant installed.
  • Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant in each group by the contra angle handpiece with special adaptor
  • We connect magnetic attachment(flat) for each groups on complete denture by pick up procedure at day of implant installation
  • All patients will receive complete denture before implant installation .
  • The CBCT examination should be take
  • patients received infiltration local anesthesia.
  • A crestal incision is made using No. 15 c blade
  • Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant by the contra angle handpiece with special adaptor
  • We connect magnetic attachment(flat) on complete denture by pick up procedure at day of implant installation.
  • Implant stability will be measured using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks.
  • Patient satisfaction measure in 2 weak and after 12 weak by Denture satisfaction questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
name of measurement: Patient satisfaction
Time Frame: Patient satisfaction measure in 2 weak
Denture satisfaction questionnaire
Patient satisfaction measure in 2 weak
name of measurement: Patient satisfaction
Time Frame: Patient satisfaction measure in 12 weak
Denture satisfaction questionnaire
Patient satisfaction measure in 12 weak

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
name of measurement: implant stability
Time Frame: Implant stability will be measure at day of implant
Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ .measurement tool is smart peg attached to implant and hand-held probe.
Implant stability will be measure at day of implant
name of measurement: implant stability
Time Frame: Implant stability will be measure after 2 weak
Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ .measurement tool is smart peg attached to implant and hand-held probe.
Implant stability will be measure after 2 weak
name of measurement: implant stability
Time Frame: Implant stability will be measure after 4 weak
Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe.
Implant stability will be measure after 4 weak
name of measurement: implant stability
Time Frame: Implant stability will be measure after 8 weak
Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe.
Implant stability will be measure after 8 weak
name of measurement: implant stability
Time Frame: Implant stability will be measure after 12 weak
Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe.
Implant stability will be measure after 12 weak

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

January 30, 2021

Study Completion (Anticipated)

April 30, 2021

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 3042020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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