Compressive ImplantsNCT06514391
Immediate Loading of Four Single Piece Compressive Implants for Bar Retained Mandibular Overdenture
A study testing compressive single piece dental implant in people with Compressive Implants, run by Mansoura University at 1 site in Egypt.
Trial summary
this study was done to evaluate clinically and radiographically four single piece inter-foraminal compressive implant connected via digitally designed co-cr milled bar with distal cantilever supporting mandibular overdenture. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Compressive Implants
- What is being tested?
- compressive single piece dental implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2023to 13 Jun 2024
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- They were healthy, free from any systemic diseases relating to the bone resorption such as uncontrolled diabetics or osteoprosis .This was achieved through medical history and clinical examination by physician.
- They have completely edentulous maxilla opposed by completely edentulous mandible
- All patients have sufficient inter-arch space for overdenture and milled bar construction not less than 12mm
- All patients are of Angel's class I maxillo-mandibular relationship.
- All patients must have mandibular bone height interforaminally not less than 8-10 mm as verified by cone beam C.T.
Who cannot join
- Patients with systemic issues such as recent myocardial infarction, hepatic patients, bleeding disorders, autoimmune diseases, hyperparathyroidism
- Uncontrolled diabetes mellitus
- Severe osteoporosis
- Cancer
- Recent organ transplants, long-term corticosteroid use
- Radiotherapy
Show all 10Show fewer
- Uncooperative patients with psychiatric disorders
- Heavy smokers
- Poor oral hygiene
- Parafunctional habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Loading of Four Single Piece Compressive Implants for Bar Retained Mandibular Overdenture: A Study of Peri Implant Soft Tissue Health and Marginal Bone Loss
this study was done to evaluate clinically and radiographically four single piece inter-foraminal compressive implant connected via digitally designed co-cr milled bar with distal cantilever supporting mandibular overdenture. The evaluation will be done clinically and radiographically as following:
- Marginal bone loss
- Soft tissue changes around the implants
Read the detailed description
Six patients of age ranging from 40 to 60years (mean 50 years) were selected for this study from the out patients clinic, Prosthodontics department, Faculty of Dentistry, Mansoura University.
- Preparation of the patient for implant placement:
- A cone beam C.T was done for each patient to determine the bone height and the adequate sites for the placement of four interforaminal implants.
- Mandibular denture was constructed to aid in designing of surgical stent to guide in implant placement.
II) Surgical phase :
- Surgical stent was used to guide in implant placement. All implants were placed according to the flapless protocol under local anesthesia.
- All patients received four dental implants located anterior to the mental foramen in canine and premolar position.
III) Prosthetic phase:
- The necks of the placed implants were bent up to 15 degree to ensure parallelism.
- Intraoral final impression was done by intraoral scanner to be used for digital designing of the milled bar and the final prosthesis.
- bar design was milled in PMMA resin material and tried over implants, then resin bar try-in was invested and casted in co-cr alloy.
- Final bar was inserted intra-orally after finishing and polishing
- The four implant bar assembly was then loaded by the prefabricated acrylic denture according to Browaeys H et al , 2014. Access holes were made above the abutment to be finally relined in the patient mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol.
- The occlusion was adjusted and the patients were instructed to go on soft diet for the first 48 hours until final impressions and delivery of milled bar overdenture were done.
IV) Evaluation:
Probing depth was measured for each implant using plastic probe and radiographic evaluation of the peri-implant marginal bone loss by using cone beam CT started for the patients from the delivery of final prosthesis (T0) and continue for 6 months (T6) and 12 month (T12) from insertion.
- Conditions
- Compressive Implants
- Being tested
- compressive single piece dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compressive single piece dental implantProcedure or surgery
4 inter-foraminal single piece compressive dental implants were placed in the mandible via flapless protocol by the aid of stereolithographic surgical guide
| Study group | Role | What they receive |
|---|---|---|
| compressive one piece implants with bar attachment | Experimental | All patients received 4 mandibular inter-foraminal single piece compressive implants, bar attachment connecting 4 implants was then cemented and complete mandibular overdenture was attached to bar via peek clips Receives: Procedure: compressive single piece dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant marginal bone loss
Peri-implant marginal bone loss was evaluated for each implant by the aid of cone beam CT scan
Measured: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)
Secondary outcomes (1)
Peri-implant soft tissue health
probing depth was measured for each implant by the aid of plastic probe
Measured: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start15 Feb 2023
- Primary completion24 Apr 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compressive ImplantsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all patients recieved 4 inter-foraminal compressive single piece dental implants in the mandible, then milled bar was digitally constructed and cemented to 4 implants to support mandibular implant overdenture
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed shady, Mansoura University
- Investigators
- Mohamed Shady, MD, Principal investigator, Mansoura University Faculty of Dentistry, Prosthodontics department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514391
- Sponsor's protocol ID
- A14030123
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Loading of Four Single Piece Compressive Implants for Bar Retained Mandibular Overdenture: A Study of Peri Implant Soft Tissue Health and Marginal Bone Loss
- ClinicalTrials.gov ID
- NCT06514391
- Acronym / sponsor ID
- A14030123
- Conditions
- Compressive Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 23 Jul 2024 (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.
this study was done to evaluate clinically and radiographically four single piece inter-foraminal compressive implant connected via digitally designed co-cr milled bar with distal cantilever supporting mandibular overdenture. The evaluation will be done clinically and radiographically as following:
- Marginal bone loss
- Soft tissue changes around the implants
Detailed description
Six patients of age ranging from 40 to 60years (mean 50 years) were selected for this study from the out patients clinic, Prosthodontics department, Faculty of Dentistry, Mansoura University.
- Preparation of the patient for implant placement:
- A cone beam C.T was done for each patient to determine the bone height and the adequate sites for the placement of four interforaminal implants.
- Mandibular denture was constructed to aid in designing of surgical stent to guide in implant placement.
II) Surgical phase :
- Surgical stent was used to guide in implant placement. All implants were placed according to the flapless protocol under local anesthesia.
- All patients received four dental implants located anterior to the mental foramen in canine and premolar position.
III) Prosthetic phase:
- The necks of the placed implants were bent up to 15 degree to ensure parallelism.
- Intraoral final impression was done by intraoral scanner to be used for digital designing of the milled bar and the final prosthesis.
- bar design was milled in PMMA resin material and tried over implants, then resin bar try-in was invested and casted in co-cr alloy.
- Final bar was inserted intra-orally after finishing and polishing
- The four implant bar assembly was then loaded by the prefabricated acrylic denture according to Browaeys H et al , 2014. Access holes were made above the abutment to be finally relined in the patient mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol.
- The occlusion was adjusted and the patients were instructed to go on soft diet for the first 48 hours until final impressions and delivery of milled bar overdenture were done.
IV) Evaluation:
Probing depth was measured for each implant using plastic probe and radiographic evaluation of the peri-implant marginal bone loss by using cone beam CT started for the patients from the delivery of final prosthesis (T0) and continue for 6 months (T6) and 12 month (T12) from insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all patients recieved 4 inter-foraminal compressive single piece dental implants in the mandible, then milled bar was digitally constructed and cemented to 4 implants to support mandibular implant overdenture
| Arm | Type | Receives |
|---|---|---|
| compressive one piece implants with bar attachment | Experimental | Procedure: compressive single piece dental implantAll patients received 4 mandibular inter-foraminal single piece compressive implants, bar attachment connecting 4 implants was then cemented and complete mandibular overdenture was attached to bar via peek clips |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- They were healthy, free from any systemic diseases relating to the bone resorption such as uncontrolled diabetics or osteoprosis .This was achieved through medical history and clinical examination by physician.
- They have completely edentulous maxilla opposed by completely edentulous mandible
- All patients have sufficient inter-arch space for overdenture and milled bar construction not less than 12mm
- All patients are of Angel's class I maxillo-mandibular relationship.
- All patients must have mandibular bone height interforaminally not less than 8-10 mm as verified by cone beam C.T.
Key exclusion criteria (10 listed)
- Patients with systemic issues such as recent myocardial infarction, hepatic patients, bleeding disorders, autoimmune diseases, hyperparathyroidism
- Uncontrolled diabetes mellitus
- Severe osteoporosis
- Cancer
- Recent organ transplants, long-term corticosteroid use
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 |
|---|---|---|
| compressive single piece dental implant4 inter-foraminal single piece compressive dental implants were placed in the mandible via flapless protocol by the aid of stereolithographic surgical guide | Procedure or surgery | compressive one piece implants with bar attachment |
Primary outcome
Peri-implant marginal bone loss
Time frame: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)
Peri-implant marginal bone loss was evaluated for each implant by the aid of cone beam CT scan
1 secondary outcome
Peri-implant soft tissue health
Time frame: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Compressive Implants
Recruiting
Effect of Immediate Placement and Loading of Compressive Versus Conventional Implants
Other Endosseous Dental Implant Failure
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Active, not recruitingObservational study
Primary and Secondary Stability of a One-Piece Compressive Implant System
Dental Implant
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.
Mohamed Shady, MD principal investigator
Mansoura University Faculty of Dentistry, Prosthodontics department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compressive single piece dental implant in people with Compressive Implants, run by Mansoura University at 1 site in Egypt.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant marginal bone loss (time frame: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.