Implant TherapyNCT05824949
Osseodensification Versus Conventional Drilling Effect on Implant Stability
A study testing osseodensification drilling and conventional drilling in people with Implant Therapy, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
Trial summary
A total of 80 implants were placed in the posterior region of the maxilla in 40 patients in a split-mouth design. Bone quality was classified into type I, II, III, IV, or V as assessed preoperatively on cone-beam computed tomography (CBCT) . Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Therapy
- What is being tested?
- osseodensification drilling and conventional drilling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 4 Apr 2022to 1 Feb 2023
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (a) Bilateral edentulism in the maxillary posterior region dating back more than 6 months,
- (b) sufficient bone height (distance between the bone crest and maxillary sinus >8 mm) and width at the alveolar crest (≥6 mm) that would not necessitate bone augmentation,
- (c) at least 2 mm vestibular keratinized mucosa width and 3 mm mucosa thickness,
- (d) full-mouth plaque and bleeding scores <20%.
Who cannot join
- patients with systemic diseases, conditions, or used medications having the potential to impair surgery, bone, and wound healing dynamics (such as diabetes) will be excluded.
- patients who are allergic to antibiotics and non-steroidal anti-inflammatory drugs
- bone height <8mm
- ridge and soft tissue deficiencies requiring augmentation procedures and
- endodontic or periodontal lesions neighboring the edentulous sites will be also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Osseodensification and Conventional Drilling Protocols on Implants Mechanical and Biological Stability in Posterior Maxilla: A Randomized Controlled Clinical Trial
A total of 80 implants were placed in the posterior region of the maxilla in 40 patients in a split-mouth design. Bone quality was classified into type I, II, III, IV, or V as assessed preoperatively on cone-beam computed tomography (CBCT) . Primary implant stability was measured with insertion torque and resonance frequency analysis (ISQ values). Secondary stability was measured by ISQ at abutment installation.
- Conditions
- Implant Therapy
- Being tested
- osseodensification drilling, conventional drilling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osseodensification drillingProcedure or surgery
Implant mechanical and biological stability measured using ISQ values at the time of implant placement and at abutment connection for 40 implants placed in the posterior maxillary area using the osseodensification protocol.
conventional drillingProcedure or surgery
Implant mechanical and biological stability measured using ISQ values at the time of implant placement and at abutment connection for 40 implants placed in the posterior maxillary area using the conventional drilling protocol.
| Study group | Role | What they receive |
|---|---|---|
| Osseodensification (test) group | Experimental | installation of 40 implants using the osseodensification protocol + measurement of implant stability (ISQ) Receives: Procedure: osseodensification drilling |
| Conventional (control) group | Active comparator | installation of 40 implants using the conventional drilling protocol + measurement of implant stability (ISQ) Receives: Procedure: conventional drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical or primary stability
ISQ values at implant installation
Measured: directly after implant placement
Biological or secondary stability
ISQ values at abutment connection
Measured: 4 months after implant installation
Secondary outcomes (1)
Torque value (N/cm)
Torque value shown at the physiodispenser screen at the end of implant installation
Measured: directly after implant insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start4 Apr 2022
- Primary completion1 Jun 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant TherapyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab American University (Palestine)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abu-Ta'a, Arab American University (Palestine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824949
- Sponsor's protocol ID
- Implant stability
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Osseodensification and Conventional Drilling Protocols on Implants Mechanical and Biological Stability in Posterior Maxilla: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05824949
- Acronym / sponsor ID
- Implant stability
- Conditions
- Implant Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Arab American University (Palestine)University, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 24 Apr 2023 (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.
A total of 80 implants were placed in the posterior region of the maxilla in 40 patients in a split-mouth design. Bone quality was classified into type I, II, III, IV, or V as assessed preoperatively on cone-beam computed tomography (CBCT) . Primary implant stability was measured with insertion torque and resonance frequency analysis (ISQ values). Secondary stability was measured by ISQ at abutment installation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osseodensification (test) group | Experimental | Procedure: osseodensification drillinginstallation of 40 implants using the osseodensification protocol + measurement of implant stability (ISQ) |
| Conventional (control) group | Active comparator | Procedure: conventional drillinginstallation of 40 implants using the conventional drilling protocol + measurement of implant stability (ISQ) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (a) Bilateral edentulism in the maxillary posterior region dating back more than 6 months,
- (b) sufficient bone height (distance between the bone crest and maxillary sinus >8 mm) and width at the alveolar crest (≥6 mm) that would not necessitate bone augmentation,
- (c) at least 2 mm vestibular keratinized mucosa width and 3 mm mucosa thickness,
- (d) full-mouth plaque and bleeding scores <20%.
Key exclusion criteria (5 listed)
- patients with systemic diseases, conditions, or used medications having the potential to impair surgery, bone, and wound healing dynamics (such as diabetes) will be excluded.
- patients who are allergic to antibiotics and non-steroidal anti-inflammatory drugs
- bone height <8mm
- ridge and soft tissue deficiencies requiring augmentation procedures and
- endodontic or periodontal lesions neighboring the edentulous sites will be also excluded.
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 drillingImplant mechanical and biological stability measured using ISQ values at the time of implant placement and at abutment connection for 40 implants placed in the posterior maxillary area using the osseodensification protocol. | Procedure or surgery | Osseodensification (test) group |
| conventional drillingImplant mechanical and biological stability measured using ISQ values at the time of implant placement and at abutment connection for 40 implants placed in the posterior maxillary area using the conventional drilling protocol. | Procedure or surgery | Conventional (control) group |
Primary outcome
Mechanical or primary stability
Time frame: directly after implant placement
ISQ values at implant installation
Biological or secondary stability
Time frame: 4 months after implant installation
ISQ values at abutment connection
1 secondary outcome
Torque value (N/cm)
Time frame: directly after implant insertion
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 24 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 drilling and conventional drilling in people with Implant Therapy, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
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: finished, as of the sponsor's last update on 24 Apr 2023. 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 Palestinian Territories. 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?
Mechanical or primary stability (time frame: directly after implant placement). 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 24 Apr 2023.