Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment
NCT ID: NCT04438616
Last Updated: 2020-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
28 participants
INTERVENTIONAL
2020-09-01
2021-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Patient Satisfaction in Single Implant Mandibular Complete Overdentures Retained by CM LOC Versus Ball Attachment
NCT02923661
Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion
NCT03326453
Compare the Difference in Occlusal Force Distribution and Denture Retention Using 2 Different Denture Base Materials in Implant Retained Overdenture
NCT07250503
Different Attachment Systems in Mandibular Single Implant Overdenture
NCT07120256
Unilateral Attachment Versus Tooth Implant Supported Bridge
NCT04301115
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
dome magnetic attachment
* 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
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
flat magnetic attachment
* 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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dome magnetic attachment
* 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
flat magnetic attachment
* 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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age range from 40 to 70 year old
* Skeletal class 1
* Both sexes.
Exclusion Criteria
* 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,.
40 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hussein Hatam Jawad
Main-Supervisor :Dr.Ahmed fahmy (Ass.professor of prosthodontics, faculity of dentistry ,cairo university ) \co-supervisor :Amr ahmednaguib (lecturer of prosthodontic ) \ Principle Investigator.:Hussein hatam jawad
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
runnd s zwain, bachelor
Role: CONTACT
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3042020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.