- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04438616
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: hussein H moalla, bachelor
- Phone Number: 02201021422480
- Email: husein_hatam@yahoo.com
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
|
|
Active Comparator: flat magnetic attachment
|
|
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.
Sponsor
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
- Boerrigter EM, Geertman ME, Van Oort RP, Bouma J, Raghoebar GM, van Waas MA, van't Hof MA, Boering G, Kalk W. Patient satisfaction with implant-retained mandibular overdentures. A comparison with new complete dentures not retained by implants--a multicentre randomized clinical trial. Br J Oral Maxillofac Surg. 1995 Oct;33(5):282-8. doi: 10.1016/0266-4356(95)90038-1.
- Allen PF, McMillan AS, Walshaw D. A patient-based assessment of implant-stabilized and conventional complete dentures. J Prosthet Dent. 2001 Feb;85(2):141-7. doi: 10.1067/mpr.2001.113214.
- Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, Head T, Lund JP, MacEntee M, Mericske-Stern R, Mojon P, Morais J, Naert I, Payne AG, Penrod J, Stoker GT, Tawse-Smith A, Taylor TD, Thomason JM, Thomson WM, Wismeijer D. The McGill consensus statement on overdentures. Mandibular two-implant overdentures as first choice standard of care for edentulous patients. Montreal, Quebec, May 24-25, 2002. Int J Oral Maxillofac Implants. 2002 Jul-Aug;17(4):601-2. No abstract available.
- Tallgren A. The continuing reduction of the residual alveolar ridges in complete denture wearers: a mixed-longitudinal study covering 25 years. J Prosthet Dent. 1972 Feb;27(2):120-32. doi: 10.1016/0022-3913(72)90188-6. No abstract available.
- Barao VA, Assuncao WG, Tabata LF, Delben JA, Gomes EA, de Sousa EA, Rocha EP. Finite element analysis to compare complete denture and implant-retained overdentures with different attachment systems. J Craniofac Surg. 2009 Jul;20(4):1066-71. doi: 10.1097/SCS.0b013e3181abb395.
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
Additional Relevant MeSH Terms
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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