Clinical trial NCT04438616: Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment
Official title: Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment for Implant Retained Mandibular Over Denture Following Immediate Loading
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous Alveolar Ridge
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: * 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

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

Eligibility criteria: 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,.

Primary outcomes:
measure: name of measurement: Patient satisfaction
timeFrame: Patient satisfaction measure in 2 weak
measure: name of measurement: Patient satisfaction
timeFrame: Patient satisfaction measure in 12 weak
Secondary outcomes:
measure: name of measurement: implant stability
timeFrame: Implant stability will be measure at day of implant
measure: name of measurement: implant stability
timeFrame: Implant stability will be measure after 2 weak
measure: name of measurement: implant stability
timeFrame: Implant stability will be measure after 4 weak
measure: name of measurement: implant stability
timeFrame: Implant stability will be measure after 8 weak
measure: name of measurement: implant stability
timeFrame: Implant stability will be measure after 12 weak
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.