Dental ImplantNCT04541641
Clinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique.
A study testing New Reverse Drilling technique and osteotome technique in people with Dental Implant, run by Cairo University.
Trial summary
The study will compare between osteotome technique and New Reverse Drilling Technique in the placement of dental implant in posterior maxilla , primary outcome will be Implant stability that will be measured by Periotest device . follow up for 6 month. secondary outcomes will be crestal bone loss , pain and swelling. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- New Reverse Drilling technique and osteotome technique
- 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 Oct 2020to 1 Aug 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Partially edentulous patients in the maxillary posterior region.
- Systemically healthy patient.
- Presence of proper inter-arch space for placement of the implant prosthetic part.
- Sufficient bone height and width for implant placement (bone height ≥10mm and bone width ≥6mm).
- Non-smoker.
- Patients who are ≥ 20 years old.
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- Good oral hygiene.
- Acceptance of a one year follow-up period.
- Informed consent is provided by the patient.
Who cannot join
- Patients with systemic conditions that may interfere with implant stability,
- Patients with local pathological defects related to the area of interest.
- Unmotivated, uncooperative patients with poor oral hygiene.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
- Inadequate inter-arch space for implant prosthetic part
About this study
Official title: Clinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique: A Randomized Controlled Clinical Trial
The study will compare between osteotome technique and New Reverse Drilling Technique in the placement of dental implant in posterior maxilla , primary outcome will be Implant stability that will be measured by Periotest device . follow up for 6 month.
secondary outcomes will be crestal bone loss , pain and swelling.
- Conditions
- Dental Implant
- Being tested
- New Reverse Drilling technique, osteotome technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Reverse Drilling techniqueProcedure or surgery
a new technique of dental implant drilling that promote osseodensification by rotating the drills anti-clockwise rather than clockwise to promote bone condensation rather than bone cutting
osteotome techniqueProcedure or surgery
a technique for dental implant placement by using the osteotome to condense the bone and create an osteotome rather than cutting the bone
| Study group | Role | What they receive |
|---|---|---|
| osteotome group | Experimental | Not described Receives: Procedure: osteotome technique |
| New Reverse Drilling technique | Experimental | Not described Receives: Procedure: New Reverse Drilling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
the stability of the dental implant when placed in the maxilla of the patient and it will be measured by periotest
Measured: 6 months
Secondary outcomes (1)
crestal bone loss
amount of bone loss around the implant . measured in MM with CBVT radiograph
Measured: 6 monthz
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Magdy Awad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541641
- Sponsor's protocol ID
- PER6-3-1
- Status last verified
- Sep 2020
- First submitted
- 27 Jul 2020
- Last updated
- 9 Sep 2020
- Results posted
- 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 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Stability of Implants Placed in Partially Edentulous Maxilla With Poor Bone Quality Via New Reverse Drilling Technique Versus Osteotome Technique: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04541641
- Acronym / sponsor ID
- PER6-3-1
- Conditions
- Dental Implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 9 Sep 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.
The study will compare between osteotome technique and New Reverse Drilling Technique in the placement of dental implant in posterior maxilla , primary outcome will be Implant stability that will be measured by Periotest device . follow up for 6 month.
secondary outcomes will be crestal bone loss , pain and swelling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| osteotome group | Experimental | Procedure: osteotome technique |
| New Reverse Drilling technique | Experimental | Procedure: New Reverse Drilling technique |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Partially edentulous patients in the maxillary posterior region.
- Systemically healthy patient.
- Presence of proper inter-arch space for placement of the implant prosthetic part.
- Sufficient bone height and width for implant placement (bone height ≥10mm and bone width ≥6mm).
- Non-smoker.
Key exclusion criteria (5 listed)
- Patients with systemic conditions that may interfere with implant stability,
- Patients with local pathological defects related to the area of interest.
- Unmotivated, uncooperative patients with poor oral hygiene.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
- Inadequate inter-arch space for implant prosthetic part
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 |
|---|---|---|
| New Reverse Drilling techniquea new technique of dental implant drilling that promote osseodensification by rotating the drills anti-clockwise rather than clockwise to promote bone condensation rather than bone cutting | Procedure or surgery | New Reverse Drilling technique |
| osteotome techniquea technique for dental implant placement by using the osteotome to condense the bone and create an osteotome rather than cutting the bone | Procedure or surgery | osteotome group |
Primary outcome
implant stability
Time frame: 6 months
the stability of the dental implant when placed in the maxilla of the patient and it will be measured by periotest
1 secondary outcome
crestal bone loss
Time frame: 6 monthz
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing New Reverse Drilling technique and osteotome technique in people with Dental Implant, 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 9 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 9 Sep 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?
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?
implant stability (time frame: 6 months). 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 9 Sep 2020.