Implant StabilityNCT06599112
Clinical and Radiographic Evaluation of Implant Stability in Healed Maxillary Posterior Sites Comparing Osteotome, Osseodensification and Conventional Drilling Implant Placement Techniques
A study testing Densah Burs, Osteotomes and Conventional drilling in people with Implant Stability, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare the implant stability values following implant placement via Osteotomes and via Osseodensification using Densah Burs versus implant placement using conventional drilling technique in patients with upper posterior partially edentulous ridges as well as evaluating the crestal bone loss around… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Stability
- What is being tested?
- Densah Burs, Osteotomes and Conventional drilling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2024to Dec 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with an age range of 25-70 years
- Patients with systemic health
- Patient with missing teeth in the upper posterior area
- Patients with D3 or D4 type of alveolar bone
- Healed bony sites with sufficient dimension for implant placement
- Vertical height (≥ 10 mm)
Show all 12Show fewer
- Bucco-lingual dimension (≥ 5.5 mm)
- Mesio-distal width (≥6.5 mm)
- Patients with periodontal health (PD < 4mm, BOP < 10%)
- Inter-arch space of 7.5 to allow implant restoration
- Good oral hygiene
- Cooperative patients who accepted the trial follow up period and sign the informed consent
Who cannot join
- Pregnant females
- Smokers
- Patients with habits that may compromise the longevity and affect the result of the implant as alcoholism or parafunctional habits
- History of radiotherapy or use of bisphosphonates
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza
Cairo University, 0223642705
Nadine Yehia Mohamed, Bachelor's degree
About this study
Official title: Clinical and Radiographic Evaluation of Implant Stability in Healed Maxillary Posterior Sites Comparing Osteotome, Osseodensification and Conventional Drilling Implant Placement Techniques: A Randomized Clinical Trial
This study aims to compare the implant stability values following implant placement via Osteotomes and via Osseodensification using Densah Burs versus implant placement using conventional drilling technique in patients with upper posterior partially edentulous ridges as well as evaluating the crestal bone loss around temporary restorations following the three compared drilling techniques.
Read the detailed description
- Patients with partially edentulous ridges seeking restoration of their missing teeth, with enough measurements for implant placement will be recruited from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry-Cairo University to participate in this study and will be randomized to be either undergoing conventional drilling according to the manufacturer's instructions (control group) or either one of the two intervention groups; Intervention group (A) where implant placement will be done using the Osseodensification technique by the Densah burs or Intervention group (B) where the implant placement will be done using the Osteotomes.
- Neobiotech IS III active implants will be used in this study, they have an osseoconductive SLA-coated surface, a tapered design with a crestal macrothread design (0.8 pitch), a self compactable apex as well as deep thread to maximize implant stability. The implant has a platform switching feature and a conical/hex design.
- A temporary PMMA crown after 3 months from implant placement and will be kept for follow up for a year then definitive final restoration will be made.
- Conditions
- Implant Stability
- Being tested
- Densah Burs, Osteotomes, Conventional drilling
- Keywords
- Dental implant placement, Osseodensification, Osteotomes, Implant stability, Crestal bone loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Densah BursOther
Series of drilling burs inserted in the osteotomy with special design that have a large negative rake angle flute, a cutting chisel edge and a tapered shank, so as they enter deeper into the osteotomy and they have a progressively increasing diameter that controls the expansion process. These burs are used with a standard surgical engine and can densify bone by rotating in the noncutting direction (counterclockwise at 800-1,200 rotations per minute) or drill bone by rotating in the cutting direction (clockwise at 800-1,200 rotations per minute) with an in and out movement together with copious saline irrigation and increasing bone plasticity and ability to expand under rate dependent stress.
OsteotomesOther
The osteotomes kit are a series of tools that first designed by Summers in 1994. The concept was to maintain the existing bone by compressing trabecular bone laterally and apically with minimal trauma to improve the bone density. The condensed bone in this way will have to put in act a double repairing mechanism, from one side represented by the normal processes of osteointegration and on the other side from the processes of the reparation post fracture like that depends on BMU (bone modelling units) which create new spaces for the new vessels and afterwards filling all the gaps between the bone and the implant.
Conventional drillingOther
The implant drilling kit provided by the manufacturer will be used for the implant placement, using the pilot drill followed by consequent drills according to the size of the osteotomy needed.
| Study group | Role | What they receive |
|---|---|---|
| Conventional drilling for implant placement | Active comparator | Implant placement in this group will be by conventional drilling according to the manufacturer's instructions (consequent drills according to the kit provided) Receives: Other: Conventional drilling |
| Implant placement using Densah Burs | Experimental | Densah Burs provided by Versah will be used as the Osseodensification drilling technique for implant placement in this group. (consequent drilling according to the kit provided) Receives: Other: Densah Burs |
| Implant placement using Osteotomes | Experimental | Osteotomes with different serial diameters will be used following the pilot drill to expand and condense the osteotomy site as a technique for implant placement. Receives: Other: Osteotomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability.
ISQ units. (Implant Stability Quotient)
Measured: Will take place at same day,1,2,3,4,6,8 ,12and 16 weeks postoperatively.
Secondary outcomes (1)
Crestal bone loss
Millimeters in standardized periapical radiograph
Measured: Will be evaluated to determine the initial crestal bone level at day of the surgery as well at 12 and 48 weeks postoperatively.
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 startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant StabilityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups. Control Group Intervention group (A) Intervention group (B)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Yehia Mohamed Mohamed Fayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599112
- Sponsor's protocol ID
- PERIO631- Perio
- Status last verified
- Sep 2024
- First submitted
- 16 Aug 2024
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Implant Stability in Healed Maxillary Posterior Sites Comparing Osteotome, Osseodensification and Conventional Drilling Implant Placement Techniques: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06599112
- Acronym / sponsor ID
- PERIO631- Perio
- Conditions
- Implant Stability
- Keywords
- Dental implant placement, Osseodensification, Osteotomes, Implant stability, Crestal bone loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 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.
This study aims to compare the implant stability values following implant placement via Osteotomes and via Osseodensification using Densah Burs versus implant placement using conventional drilling technique in patients with upper posterior partially edentulous ridges as well as evaluating the crestal bone loss around temporary restorations following the three compared drilling techniques.
Detailed description
- Patients with partially edentulous ridges seeking restoration of their missing teeth, with enough measurements for implant placement will be recruited from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry-Cairo University to participate in this study and will be randomized to be either undergoing conventional drilling according to the manufacturer's instructions (control group) or either one of the two intervention groups; Intervention group (A) where implant placement will be done using the Osseodensification technique by the Densah burs or Intervention group (B) where the implant placement will be done using the Osteotomes.
- Neobiotech IS III active implants will be used in this study, they have an osseoconductive SLA-coated surface, a tapered design with a crestal macrothread design (0.8 pitch), a self compactable apex as well as deep thread to maximize implant stability. The implant has a platform switching feature and a conical/hex design.
- A temporary PMMA crown after 3 months from implant placement and will be kept for follow up for a year then definitive final restoration will be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups. Control Group Intervention group (A) Intervention group (B)
| Arm | Type | Receives |
|---|---|---|
| Conventional drilling for implant placement | Active comparator | Other: Conventional drillingImplant placement in this group will be by conventional drilling according to the manufacturer's instructions (consequent drills according to the kit provided) |
| Implant placement using Densah Burs | Experimental | Other: Densah BursDensah Burs provided by Versah will be used as the Osseodensification drilling technique for implant placement in this group. (consequent drilling according to the kit provided) |
| Implant placement using Osteotomes | Experimental | Other: OsteotomesOsteotomes with different serial diameters will be used following the pilot drill to expand and condense the osteotomy site as a technique for implant placement. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with an age range of 25-70 years
- Patients with systemic health
- Patient with missing teeth in the upper posterior area
- Patients with D3 or D4 type of alveolar bone
- Healed bony sites with sufficient dimension for implant placement
Key exclusion criteria (4 listed)
- Pregnant females
- Smokers
- Patients with habits that may compromise the longevity and affect the result of the implant as alcoholism or parafunctional habits
- History of radiotherapy or use of bisphosphonates
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 |
|---|---|---|
| Densah BursSeries of drilling burs inserted in the osteotomy with special design that have a large negative rake angle flute, a cutting chisel edge and a tapered shank, so as they enter deeper into the osteotomy and they have a progressively increasing diameter that controls the expansion process. These burs are used with a standard surgical engine and can densify bone by rotating in the noncutting direction (counterclockwise at 800-1,200 rotations per minute) or drill bone by rotating in the cutting direction (clockwise at 800-1,200 rotations per minute) with an in and out movement together with copious saline irrigation and increasing bone plasticity and ability to expand under rate dependent stress. | Other | Implant placement using Densah Burs |
| OsteotomesThe osteotomes kit are a series of tools that first designed by Summers in 1994. The concept was to maintain the existing bone by compressing trabecular bone laterally and apically with minimal trauma to improve the bone density. The condensed bone in this way will have to put in act a double repairing mechanism, from one side represented by the normal processes of osteointegration and on the other side from the processes of the reparation post fracture like that depends on BMU (bone modelling units) which create new spaces for the new vessels and afterwards filling all the gaps between the bone and the implant. | Other | Implant placement using Osteotomes |
| Conventional drillingThe implant drilling kit provided by the manufacturer will be used for the implant placement, using the pilot drill followed by consequent drills according to the size of the osteotomy needed. | Other | Conventional drilling for implant placement |
Primary outcome
Implant stability.
Time frame: Will take place at same day,1,2,3,4,6,8 ,12and 16 weeks postoperatively.
ISQ units. (Implant Stability Quotient)
1 secondary outcome
Crestal bone loss
Time frame: Will be evaluated to determine the initial crestal bone level at day of the surgery as well at 12 and 48 weeks postoperatively.
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
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Effectiveness of Clockwise vs. Counter-Clockwise Osseodensification for Implant Site Preparation
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Densah Burs, Osteotomes and Conventional drilling in people with Implant Stability, run by Cairo 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 12 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 Nadine Yehia Mohamed, Bachelor's degree (01019885817, nadine.fayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability. (time frame: Will take place at same day,1,2,3,4,6,8 ,12and 16 weeks postoperatively.). 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.