Edentulous Alveolar RidgeNCT04438616
Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment
A study testing dome magnetic attachment and flat magnetic attachment in people with Edentulous Alveolar Ridge, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- dome magnetic attachment and flat magnetic attachment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- completely edentulous patient.
- Age range from 40 to 70 year old
- Skeletal class 1
- Both sexes.
Who cannot join
- 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,.
Trial locations and contacts
No sites are listed yet.
runnd s zwain, bachelor contact
About this study
Official title: 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
Read the 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
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- dome magnetic attachment, flat magnetic attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dome magnetic attachmentProcedure or surgery
- 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 attachmentProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| dome magnetic attachment | Active comparator | * 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 Receives: Procedure: dome magnetic attachment |
| flat magnetic attachment | Active comparator | * 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 Receives: Procedure: flat magnetic attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
name of measurement: Patient satisfaction
Denture satisfaction questionnaire
Measured: Patient satisfaction measure in 2 weak
name of measurement: Patient satisfaction
Denture satisfaction questionnaire
Measured: Patient satisfaction measure in 12 weak
Secondary outcomes (5)
name of measurement: implant stability
Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ .measurement tool is smart peg attached to implant and hand-held probe.
Measured: Implant stability will be measure at day of implant
name of measurement: implant stability
Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ .measurement tool is smart peg attached to implant and hand-held probe.
Measured: Implant stability will be measure after 2 weak
name of measurement: implant stability
Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe.
Measured: Implant stability will be measure after 4 weak
name of measurement: implant stability
Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe.
Measured: Implant stability will be measure after 8 weak
name of measurement: implant stability
Measurement unit: ISQ \ Measurement device: Osstell device \ scale: 1-100 ISQ measurement tool is smart peg attached to implant and hand-held probe.
Measured: Implant stability will be measure after 12 weak
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Jan 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Hatam Jawad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438616
- Sponsor's protocol ID
- 3042020
- Status last verified
- Apr 2020
- First submitted
- 15 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 8555143Allen 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.
PubMed 11208203Feine 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.
PubMed 12182304Tallgren 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.
PubMed 4500507Barao 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.
PubMed 19553853
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment for Implant Retained Mandibular Over Denture Following Immediate Loading
- ClinicalTrials.gov ID
- NCT04438616
- Acronym / sponsor ID
- 3042020
- Conditions
- Edentulous Alveolar Ridge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dome magnetic attachment | Active comparator | Procedure: 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 |
| flat magnetic attachment | Active comparator | Procedure: 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- completely edentulous patient.
- Age range from 40 to 70 year old
- Skeletal class 1
- Both sexes.
Key exclusion criteria (5 listed)
- 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,.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | dome magnetic attachment |
| 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 | Procedure or surgery | flat magnetic attachment |
Primary outcome
name of measurement: Patient satisfaction
Time frame: Patient satisfaction measure in 2 weak
Denture satisfaction questionnaire
name of measurement: Patient satisfaction
Time frame: Patient satisfaction measure in 12 weak
Denture satisfaction questionnaire
5 secondary outcomes
name of measurement: implant stability
Time frame: Implant stability will be measure at day of implant
name of measurement: implant stability
Time frame: Implant stability will be measure after 2 weak
name of measurement: implant stability
Time frame: Implant stability will be measure after 4 weak
name of measurement: implant stability
Time frame: Implant stability will be measure after 8 weak
name of measurement: implant stability
Time frame: Implant stability will be measure after 12 weak
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Background: PubMed 8555143Boerrigter 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.
- Background: PubMed 11208203Allen 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.
- Background: PubMed 12182304Feine 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.
- Background: PubMed 4500507Tallgren 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.
- Background: PubMed 19553853Barao 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
runnd s zwain, bachelor contact
Questions about this trial
What is this clinical trial studying?
A study testing dome magnetic attachment and flat magnetic attachment in people with Edentulous Alveolar Ridge, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hussein H moalla, bachelor (02201021422480, husein_hatam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
name of measurement: Patient satisfaction (time frame: Patient satisfaction measure in 2 weak). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438616, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.