Implant Site ReactionNCT06590753
Evaluation of the Effect of Osseodensefication Technique Versus Conventional Implant Drilling Technique in Implant Supported Mandibular Overdenture
A study testing osseodensification bur in people with Implant Site Reaction, run by Badr University at 1 site in Egypt.
Trial summary
The present study will be performed to : evaluate the effect of two implant placement systems )conventional method and osseodensification method) radiographically on bone density and bone height surrounding the implant by using CBCT and clinically by probing depth and gingival index. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- osseodensification bur
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 Jan 2025
- 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 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients will have edentulous.
- Patient's age ranges from 55-65 years.
- All patients should be free from any systemic disease such as bone diseases or debilitating diseases.
- Patient's residual ridge should be covered with firm mucosa free from any signs of inflammation, ulceration, or flabby tissue.
- Patients should have good oral hygiene.
Who cannot join
- Uncooperative patients will be excluded .
- Patient with parafunctional habits (bruxism, clenching)
- Patient with xerostomia or excessive salivation.
- Patient with TMJ disorder.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Azhar university (Grils)
Cairo
Mai Ahmed, Msc, 01147620530, mai.ahmed4417@yahoo.com
About this study
Official title: Clinical and Radiographic Evaluation of the Effect of Osseodensefication Technique Versus Conventional Implant Drilling Technique on Supporting Structure in Implant Supported Mandibular Overdenture
The present study will be performed to : evaluate the effect of two implant placement systems )conventional method and osseodensification method) radiographically on bone density and bone height surrounding the implant by using CBCT and clinically by probing depth and gingival index.
Read the detailed description
Atrophic maxilla or mandible can lead to lack of prosthesis retention because of an inadequate bearing area causing both functional and physiological problems for patient, these problems can be treated for patient satisfaction with an implant supported fixed or removable complete or partial denture (1).
The use of implants to retain a mandibular over denture has been recommended as the first treatment choice for the edentulous mandible. From the available evidence; it shows that this treatment leads to a great improvement in both clinical function and patient's reported outcomes when compared to conventional complete dentures (2).
Clinical studies have reported that dental implants in the mandible have higher survival rates compared to those in the maxilla, having thinner cortical bone combined with thicker trabecular bone compared to the mandible (3). In contrast to the previous studies, additional studies in the posterior mandible showed high failure rates due to the poor bone quality as well as other additional factors (3-4).
The osseointegration process leads to new bone apposition on the implant surface and allows reaching the implant secondary stability that is the functional contact between living bone and titanium dental implant (4).
Primary implant stability is affected by both the quality and the quantity of bone of the osteotomy site. Hence, a precise evaluation of bone structure is essential before implant placement implant (5). The term bone quality depends on bone density, bone vascularity, bone metabolism and other factors that may affect implant outcome. Many authors describe bone density as being equivalent to bone quality. This includes physiological and structural parts and the degree of bone tissue mineralization (4-5).
2 Successful dental implant placement requires sufficient amount of bone thickness covering the implant so that primary stability is achieved, which is an important requirement for long term success of the implant (2, 6).
Primary implant stability is defined as the biomechanical stability upon implant insertion, being influenced by numerous factors, such as: bone quantity and quality, the geometric design of the implant, surgical technique, and insertion torque. From this stability, new bone develops around the surface of the implant, constituting a biological fixation named secondary implant stability (7, 8).
The longevity of any implant prosthesis depends on successful osseointegration and implant stability. Consistent osteotomies and densification are important to implant primary stability and to early loading (9, 10).
Unlike traditional bone drilling technologies, osseodensification does not excavate bone tissue. Rather, it preserves bone bulk, so bone tissue is simultaneously compacted and autografted in an outwardly expanding direction to form the osteotomy (11, 12). It creates a densified layer of surrounding bone through compaction autografting while simultaneously plastically expanding the bony ridge at the same time (13, 14,15).
The new burs allow bone preservation and condensation through compaction autografting during osteotomy preparation, increasing the peri-implant bone density (%BV), and the implant mechanical stability (16). .
Osseous densification was shown to increase the insertion and removal torques of the implants compared to standard drilling and extraction drilling. This demonstrates increased implant primary biomechanical stability (17).
3 Osseodensification had a direct impact on increasing the values of peak insertion torques of the implants compared to cutting drilling which indicates enhancement of initial stability of implant fixture (18).
- Conditions
- Implant Site Reaction
- Being tested
- osseodensification bur
- Keywords
- implant, Bone density, Bone height
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osseodensification burDevice
osseodensification bur
| Study group | Role | What they receive |
|---|---|---|
| conventional | Active comparator | One will be placed using the conventional drill method site preparation technique on one side of the mandible Receives: Device: osseodensification bur |
| osseodensification | Experimental | One will be placed using osseodensification (no cutting) implant site preparation technique on the other side. Receives: Device: osseodensification bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone height
CBCT Measurements
Measured: zero, 6, 12 months
bone density
CBCT Measurements
Measured: zero, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Dec 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Ahmed Abdel Fatah, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590753
- Sponsor's protocol ID
- 1147620530
- Status last verified
- Sep 2024
- First submitted
- 23 May 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of the Effect of Osseodensefication Technique Versus Conventional Implant Drilling Technique on Supporting Structure in Implant Supported Mandibular Overdenture
- ClinicalTrials.gov ID
- NCT06590753
- Acronym / sponsor ID
- 1147620530
- Conditions
- Implant Site Reaction
- Keywords
- implant, Bone density, Bone height
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 19 Sep 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.
The present study will be performed to : evaluate the effect of two implant placement systems )conventional method and osseodensification method) radiographically on bone density and bone height surrounding the implant by using CBCT and clinically by probing depth and gingival index.
Detailed description
Atrophic maxilla or mandible can lead to lack of prosthesis retention because of an inadequate bearing area causing both functional and physiological problems for patient, these problems can be treated for patient satisfaction with an implant supported fixed or removable complete or partial denture (1).
The use of implants to retain a mandibular over denture has been recommended as the first treatment choice for the edentulous mandible. From the available evidence; it shows that this treatment leads to a great improvement in both clinical function and patient's reported outcomes when compared to conventional complete dentures (2).
Clinical studies have reported that dental implants in the mandible have higher survival rates compared to those in the maxilla, having thinner cortical bone combined with thicker trabecular bone compared to the mandible (3). In contrast to the previous studies, additional studies in the posterior mandible showed high failure rates due to the poor bone quality as well as other additional factors (3-4).
The osseointegration process leads to new bone apposition on the implant surface and allows reaching the implant secondary stability that is the functional contact between living bone and titanium dental implant (4).
Primary implant stability is affected by both the quality and the quantity of bone of the osteotomy site. Hence, a precise evaluation of bone structure is essential before implant placement implant (5). The term bone quality depends on bone density, bone vascularity, bone metabolism and other factors that may affect implant outcome. Many authors describe bone density as being equivalent to bone quality. This includes physiological and structural parts and the degree of bone tissue mineralization (4-5).
2 Successful dental implant placement requires sufficient amount of bone thickness covering the implant so that primary stability is achieved, which is an important requirement for long term success of the implant (2, 6).
Primary implant stability is defined as the biomechanical stability upon implant insertion, being influenced by numerous factors, such as: bone quantity and quality, the geometric design of the implant, surgical technique, and insertion torque. From this stability, new bone develops around the surface of the implant, constituting a biological fixation named secondary implant stability (7, 8).
The longevity of any implant prosthesis depends on successful osseointegration and implant stability. Consistent osteotomies and densification are important to implant primary stability and to early loading (9, 10).
Unlike traditional bone drilling technologies, osseodensification does not excavate bone tissue. Rather, it preserves bone bulk, so bone tissue is simultaneously compacted and autografted in an outwardly expanding direction to form the osteotomy (11, 12). It creates a densified layer of surrounding bone through compaction autografting while simultaneously plastically expanding the bony ridge at the same time (13, 14,15).
The new burs allow bone preservation and condensation through compaction autografting during osteotomy preparation, increasing the peri-implant bone density (%BV), and the implant mechanical stability (16). .
Osseous densification was shown to increase the insertion and removal torques of the implants compared to standard drilling and extraction drilling. This demonstrates increased implant primary biomechanical stability (17).
3 Osseodensification had a direct impact on increasing the values of peak insertion torques of the implants compared to cutting drilling which indicates enhancement of initial stability of implant fixture (18).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional | Active comparator | Device: osseodensification burOne will be placed using the conventional drill method site preparation technique on one side of the mandible |
| osseodensification | Experimental | Device: osseodensification burOne will be placed using osseodensification (no cutting) implant site preparation technique on the other side. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients will have edentulous.
- Patient's age ranges from 55-65 years.
- All patients should be free from any systemic disease such as bone diseases or debilitating diseases.
- Patient's residual ridge should be covered with firm mucosa free from any signs of inflammation, ulceration, or flabby tissue.
- Patients should have good oral hygiene.
Key exclusion criteria (4 listed)
- Uncooperative patients will be excluded .
- Patient with parafunctional habits (bruxism, clenching)
- Patient with xerostomia or excessive salivation.
- Patient with TMJ disorder.
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 |
|---|---|---|
| osseodensification burosseodensification bur | Device | conventional, osseodensification |
Primary outcome
bone height
Time frame: zero, 6, 12 months
CBCT Measurements
bone density
Time frame: zero, 6, 12 months
CBCT Measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Implant Site Reaction
Active, not recruitingPhase 3
Local Antibiotics for Breast Implants
Implant Complication, Implant Infection
RecruitingObservational study
Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration
Implant Site Reaction
RecruitingObservational study
Peri-implant Mucosal Changes Over Time Following Implant Provisional Removal in the Esthetic Zone
Tooth Loss, Implant Site Reaction
Active, not recruiting
Clinical Comparison of On1 Two-stage Abutment With One-stage Abutment on Different Implant Neck Design
Implant Site Reaction
Recruiting
Photofunctionalization With UVC
Implant Site Reaction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osseodensification bur in people with Implant Site Reaction, run by Badr 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 4 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 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mai Ahmed, Msc (+201147620530, mai.ahmed4417@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone height (time frame: zero, 6, 12 months). 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?
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 Sep 2024.