Implant Site ReactionNCT03743545
Assessment of Heat Generation From Low Speed Drilling Without Irrigation
A study testing low speed drilling without irrigation in people with Implant Site Reaction, run by Cairo University.
Trial summary
ASSESSMENT OF LOW SPEED DRILLING WITHOUT IRRIGATION VERSUS CONVENTIONAL DRILLING WITH IRRIGATION REGARDING HEAT GENERATION AND PERI-IMPLANT MARGINAL BONE LOSS Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- low speed drilling without irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 2 Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- presence of pathological lesions heavy smokers more than 20 cigarettes per day patients with systemic disease that may affect normal healing Patients with no enough bone in posterior mandible for implant placement
About this study
Official title: ASSESSEMENT OF LOW SPEED DRILLING WITHOUT IRRIGATION VERSUS CONVENTIONEL DRILLING WITH IRRIGATION REGARDING HEAT GENERATION AND PERI-IMPLANT MARGINAL BONE LOSS
ASSESSMENT OF LOW SPEED DRILLING WITHOUT IRRIGATION VERSUS CONVENTIONAL DRILLING WITH IRRIGATION REGARDING HEAT GENERATION AND PERI-IMPLANT MARGINAL BONE LOSS
Read the detailed description
Assessment of heat generation from conventional drilling speed for dental implant placement versus biological drilling (low speed without irrigation ) by thermocouples technology And measure the primary stability of dental implants placed by the two techniques by osstel device
- Conditions
- Implant Site Reaction
- Being tested
- low speed drilling without irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low speed drilling without irrigationOther
comparing between conventional implant placement drilling speed with irrigation and experimental arm (low speed without irrigation)
| Study group | Role | What they receive |
|---|---|---|
| conventional drilling with irrigation | Active comparator | Not described Receives: Other: low speed drilling without irrigation |
| low speed without irrigation | Experimental | Not described Receives: Other: low speed drilling without irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of heat generation from low speed hand piece drills drilling by thermocouple technology
Measurement of 3 different depths(mms). Data analyzed with a three-way analysis of variance by Newman-Keulsmultiple comparison procedure. The significance level was set to a p-value of 0.05.
Measured: 6 months
Secondary outcomes (1)
stability-osstell device to assess the primary stability of placed dental implant
Resonance frequency analysis (RFA) allows assess implant stability by measuring implant oscillation frequency on the bone
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion2 Apr 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
- Model description
- healthy posterior mandible
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdel Sattar Abdel Motagly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743545
- Sponsor's protocol ID
- 28601270201414
- Status last verified
- Nov 2018
- First submitted
- 4 Nov 2018
- Last updated
- 19 Nov 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 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSEMENT OF LOW SPEED DRILLING WITHOUT IRRIGATION VERSUS CONVENTIONEL DRILLING WITH IRRIGATION REGARDING HEAT GENERATION AND PERI-IMPLANT MARGINAL BONE LOSS
- ClinicalTrials.gov ID
- NCT03743545
- Acronym / sponsor ID
- 28601270201414
- Conditions
- Implant Site Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 2 Apr 2019 (estimated)
- First posted
- 16 Nov 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.
ASSESSMENT OF LOW SPEED DRILLING WITHOUT IRRIGATION VERSUS CONVENTIONAL DRILLING WITH IRRIGATION REGARDING HEAT GENERATION AND PERI-IMPLANT MARGINAL BONE LOSS
Detailed description
Assessment of heat generation from conventional drilling speed for dental implant placement versus biological drilling (low speed without irrigation ) by thermocouples technology And measure the primary stability of dental implants placed by the two techniques by osstel device
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- healthy posterior mandible
| Arm | Type | Receives |
|---|---|---|
| conventional drilling with irrigation | Active comparator | Other: low speed drilling without irrigation |
| low speed without irrigation | Experimental | Other: low speed drilling without irrigation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- presence of pathological lesions heavy smokers more than 20 cigarettes per day patients with systemic disease that may affect normal healing Patients with no enough bone in posterior mandible for implant placement
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 |
|---|---|---|
| low speed drilling without irrigationcomparing between conventional implant placement drilling speed with irrigation and experimental arm (low speed without irrigation) | Other | conventional drilling with irrigation, low speed without irrigation |
Primary outcome
Measurement of heat generation from low speed hand piece drills drilling by thermocouple technology
Time frame: 6 months
Measurement of 3 different depths(mms). Data analyzed with a three-way analysis of variance by Newman-Keulsmultiple comparison procedure. The significance level was set to a p-value of 0.05.
1 secondary outcome
stability-osstell device to assess the primary stability of placed dental implant
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 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.
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 low speed drilling without irrigation 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 0 inclusion and 1 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 Nov 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?
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?
Measurement of heat generation from low speed hand piece drills drilling by thermocouple technology (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 19 Nov 2018.