Implant Site ReactionNCT03598049
Assessment of Dental Implants Placed in Posterior Maxillary Ridge Using Densah Burs Versus Standard Drills
A study testing densah burs osseo densification drills and conventional surgical burs drilling in people with Implant Site Reaction, run by Cairo University.
Trial summary
comparing the drilling technique of using densah burs osseo densification drills in posterior maxilla with the normal surgical kit drilling Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- densah burs osseo densification drills and conventional surgical burs drilling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Jul 2019
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤3.5 width implants.
- Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
Who cannot join
- Sinus pathology.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Trial locations and contacts
No sites are listed yet.
About this study
comparing the drilling technique of using densah burs osseo densification drills in posterior maxilla with the normal surgical kit drilling
Read the detailed description
the densification of bone using the densah burs are thought to be improving the bone quality surrounding the implants thus increasing the primary stability and decreasing the marginal bone loss surrounding the implants comparing to the normal drilling techniques using the conventional implant drilling kit
- Conditions
- Implant Site Reaction
- Being tested
- densah burs osseo densification drills, conventional surgical burs drilling
- Keywords
- Implants, Stability, Bone loss, Success
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
densah burs osseo densification drillsDevice
osseo densification of the alveolar bone in maxillary posterior ridge during implant placement
conventional surgical burs drillingDevice
conventional implant osteotomy site drilling with implant surgical kit
| Study group | Role | What they receive |
|---|---|---|
| densah burs drilling group | Experimental | implant osteotomy site drilling using the densah burs osseo densification drills Receives: Device: densah burs osseo densification drills |
| surgical burs drilling group | Active comparator | implant osteotomy site drilling using conventional surgical burs drilling Receives: Device: conventional surgical burs drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
measurement of implant stability using the ostell
Measured: at the time of surgery
Secondary outcomes (1)
Marginal bone loss
measurement of the bone level surrounding the implant using cone beam CT
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 Jul 2019 (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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira khaled ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598049
- Sponsor's protocol ID
- 47820
- Status last verified
- Aug 2018
- First submitted
- 29 Jun 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dental Implants Placed in Posterior Maxillary Ridge Using Densah Burs Versus Standard Drills
- ClinicalTrials.gov ID
- NCT03598049
- Acronym / sponsor ID
- 47820
- Conditions
- Implant Site Reaction
- Keywords
- Implants, Stability, Bone loss, Success
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 26 Jul 2018 (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.
comparing the drilling technique of using densah burs osseo densification drills in posterior maxilla with the normal surgical kit drilling
Detailed description
the densification of bone using the densah burs are thought to be improving the bone quality surrounding the implants thus increasing the primary stability and decreasing the marginal bone loss surrounding the implants comparing to the normal drilling techniques using the conventional implant drilling kit
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| densah burs drilling group | Experimental | Device: densah burs osseo densification drillsimplant osteotomy site drilling using the densah burs osseo densification drills |
| surgical burs drilling group | Active comparator | Device: conventional surgical burs drillingimplant osteotomy site drilling using conventional surgical burs drilling |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤3.5 width implants.
- Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
Key exclusion criteria (6 listed)
- Sinus pathology.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
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 burs osseo densification drillsosseo densification of the alveolar bone in maxillary posterior ridge during implant placement | Device | densah burs drilling group |
| conventional surgical burs drillingconventional implant osteotomy site drilling with implant surgical kit | Device | surgical burs drilling group |
Primary outcome
implant stability
Time frame: at the time of surgery
measurement of implant stability using the ostell
1 secondary outcome
Marginal bone loss
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing densah burs osseo densification drills and conventional surgical burs drilling in people with Implant Site Reaction, 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 4 inclusion and 6 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 14 Aug 2018. 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?
Contact Amira khaled, Masters (01207889984, amira.khaled5071@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implant stability (time frame: at the time of surgery). 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 14 Aug 2018.