Bone ResorptionNCT03212820
Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group B ) A Randomized Controlled Clinical Trial
A study testing Drilling at low speed and Drilling at conventional or high speed in people with Bone Resorption, run by Cairo University.
Trial summary
20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group) for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Drilling at low speed and Drilling at conventional or high speed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Sep 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients restoring missing maxillary teeth with implant placement.
- Both sexes.
- Age: 25-45
- Mesio-distal dimensions: Not less than 6 mm
- Bone Height: Not less than 12 mm
- Bucco-lingual dimensions: Not less than 8mm
- All measures will be assessed using CBCT.
Who cannot join
- Sites needing bone grafting or augmentation.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
About this study
Official title: Clinical Evaluation of the Effect of Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla. A Randomized Controlled Clinical Trial
20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group)
- for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low speed (50-70 rpm) without irrigation .
- In the study group: implant will be inserted in the low speed osteotomy site.
- In the control group: implants will be inserted in the conventional prepared osteotomy site.
- For both groups there is no surgical guide used.
- The flap will then be copiously irrigated with saline in preparation for closure.
- The flap will then be closed using interrupted 4/0 resorbable sutures.
- Conditions
- Bone Resorption
- Being tested
- Drilling at low speed, Drilling at conventional or high speed
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drilling at low speedProcedure or surgery
Drilling at conventional or high speedProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Biologic drilling | Experimental | drilling at low speed Receives: Procedure: Drilling at low speed |
| conventional drilling | Active comparator | drilling at conventional or high speed Receives: Procedure: Drilling at conventional or high speed |
What is being measured
The primary outcome is the main question the study is designed to answer.
crestal bone loss
measurement from radiographic analysis using digital periapical x-ray
Measured: 6 month
Secondary outcomes (2)
patient morbidity after procedure
pain value on pain scale
Measured: 1 day
Implant stability value
resonance frequency analysis using osstell
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 posted11 Jul 2017
- Study startJul 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Tarek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212820
- Sponsor's protocol ID
- Cebc.cairoun
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effect of Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03212820
- Acronym / sponsor ID
- Cebc.cairoun
- Conditions
- Bone Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 11 Jul 2017 (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.
20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group)
- for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low speed (50-70 rpm) without irrigation .
- In the study group: implant will be inserted in the low speed osteotomy site.
- In the control group: implants will be inserted in the conventional prepared osteotomy site.
- For both groups there is no surgical guide used.
- The flap will then be copiously irrigated with saline in preparation for closure.
- The flap will then be closed using interrupted 4/0 resorbable sutures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biologic drilling | Experimental | Procedure: Drilling at low speeddrilling at low speed |
| conventional drilling | Active comparator | Procedure: Drilling at conventional or high speeddrilling at conventional or high speed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients restoring missing maxillary teeth with implant placement.
- Both sexes.
- Age: 25-45
- Mesio-distal dimensions: Not less than 6 mm
- Bone Height: Not less than 12 mm
Key exclusion criteria (3 listed)
- Sites needing bone grafting or augmentation.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
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 |
|---|---|---|
| Drilling at low speed | Procedure or surgery | Biologic drilling |
| Drilling at conventional or high speed | Procedure or surgery | conventional drilling |
Primary outcome
crestal bone loss
Time frame: 6 month
measurement from radiographic analysis using digital periapical x-ray
2 secondary outcomes
patient morbidity after procedure
Time frame: 1 day
Implant stability value
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 11 Jul 2017.
- Individual participant dataSharing planned: Yes
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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 Drilling at low speed and Drilling at conventional or high speed in people with Bone Resorption, 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 7 inclusion and 3 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 11 Jul 2017. 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?
crestal bone loss (time frame: 6 month). 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 11 Jul 2017.