Implant StabilityNCT03689933
Stability of Patient-specific Root-analogue Implants and Conventional Root-form Implants for Treating Non-restorable Single-rooted Maxillary Teeth
A study testing Root analog implant in people with Implant Stability and Root Analog Implant, run by Cairo University.
Trial summary
its a experimental study comparing between the stability of immediate root fomed implant versus the conventional titanium implant Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Stability, Root Analog Implant, Conventional Root Form Implant
- What is being tested?
- Root analog implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Jan 2020
- 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
- Single rooted teeth indicated for extraction and immediate implant placement.
- The age of candidates ranges from 21 to 50 years.
Who cannot join
- Absence of any disease or systemic complication which might affect osseointegration.
- The cause of extraction mustn't be due to periodontitis or periapical infection.
About this study
its a experimental study comparing between the stability of immediate root fomed implant versus the conventional titanium implant
Read the detailed description
Patients will be selected from the out-patient clinic according to the inclusion and exclusion criteria, from where the participants will be divided into two equal groups using computer generated random table and the sequence of the random numbers will be only revealed to the Co-supervisor who will report the assigned treatment to the principal investigator.
Immediate placement of root analogue titanium dental implants. All patients in the study group will be radiographed using cone beam computed tomography for diagnosis and evaluating the attachment of the tooth and bone level.
The tooth indicated for extraction will be extracted atraumatically using periotome, socket preservation using Iodoform packing strips, and then optical scanning of the remaining tooth structure with optical scanner will be made to obtain a 3D virtual model, this model will be modified by addition of macro-retentions strictly to the interdental area to avoid any fracture in thin cortical bone, the cervical portion of implant circumference will be decreased by 0.1 to 0.2 mm to avoid pressure resorption of alveolar crest of bone and addition of prepared crown stump for the future crown to be placed.
After all additions and adjustments are being made, an STL (stereolithography) extension file followed by milling of the implant from medically grade titanium will be carried out, followed by sandblasting acid etching.
For sterilization, the implant will be washed in a 90% concentration ethanol ultrasonic bath for 10 minutes, followed by packaging and sterilizing in a steam pressure autoclave.
At the day of implant placement, removing of suture and the Iodoform gauze followed by flushing of the extraction socket using saline solution and vigorous curettage of the socket. Then implant placement will be made by hand pressure followed by tapping using mallet.
Implant stability in both groups will be measured using Periotest device. The measuring procedure will be made immediate postoperative, 3 months and 6 months.
- Conditions
- Implant Stability, Root Analog Implant, Conventional Root Form Implant, Non Restorabl Teeth
- Being tested
- Root analog implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root analog implantDevice
Also called patient specific implant
a custom made root analogue implant made from milled titanium
| Study group | Role | What they receive |
|---|---|---|
| root analog implant | Experimental | The tooth indicated for extraction will be extracted atraumatically using periotome, socket preservation using Iodoform packing strips, and then optical scanning of the remaining tooth structure with optical scanner will be made to obtain a 3D virtual model, this model will be modified by addition of macro-retentions strictly to the interdental area to avoid any fracture in thin cortical bone, the cervical portion of implant circumference will be decreased by 0.1 to 0.2 mm to avoid pressure resorption of alveolar crest of bone and addition of prepared crown stump for the future crown to be placed. Receives: Device: Root analog implant |
| conventional stock root-form titanium implant | Active comparator | Using a conventional implant as a comparator as it's the gold stander in restoring the non-restorable teeth. Receives: Device: Root analog implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
using periotest
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 posted1 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant StabilityStudies 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
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr mohamed ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689933
- Sponsor's protocol ID
- 28902050100374
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability of Patient-specific Root-analogue Implants and Conventional Root-form Implants for Treating Non-restorable Single-rooted Maxillary Teeth
- ClinicalTrials.gov ID
- NCT03689933
- Acronym / sponsor ID
- 28902050100374
- Conditions
- Implant Stability, Root Analog Implant, Conventional Root Form Implant, Non Restorabl Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 1 Oct 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.
its a experimental study comparing between the stability of immediate root fomed implant versus the conventional titanium implant
Detailed description
Patients will be selected from the out-patient clinic according to the inclusion and exclusion criteria, from where the participants will be divided into two equal groups using computer generated random table and the sequence of the random numbers will be only revealed to the Co-supervisor who will report the assigned treatment to the principal investigator.
Immediate placement of root analogue titanium dental implants. All patients in the study group will be radiographed using cone beam computed tomography for diagnosis and evaluating the attachment of the tooth and bone level.
The tooth indicated for extraction will be extracted atraumatically using periotome, socket preservation using Iodoform packing strips, and then optical scanning of the remaining tooth structure with optical scanner will be made to obtain a 3D virtual model, this model will be modified by addition of macro-retentions strictly to the interdental area to avoid any fracture in thin cortical bone, the cervical portion of implant circumference will be decreased by 0.1 to 0.2 mm to avoid pressure resorption of alveolar crest of bone and addition of prepared crown stump for the future crown to be placed.
After all additions and adjustments are being made, an STL (stereolithography) extension file followed by milling of the implant from medically grade titanium will be carried out, followed by sandblasting acid etching.
For sterilization, the implant will be washed in a 90% concentration ethanol ultrasonic bath for 10 minutes, followed by packaging and sterilizing in a steam pressure autoclave.
At the day of implant placement, removing of suture and the Iodoform gauze followed by flushing of the extraction socket using saline solution and vigorous curettage of the socket. Then implant placement will be made by hand pressure followed by tapping using mallet.
Implant stability in both groups will be measured using Periotest device. The measuring procedure will be made immediate postoperative, 3 months and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| root analog implant | Experimental | Device: Root analog implantThe tooth indicated for extraction will be extracted atraumatically using periotome, socket preservation using Iodoform packing strips, and then optical scanning of the remaining tooth structure with optical scanner will be made to obtain a 3D virtual model, this model will be modified by addition of macro-retentions strictly to the interdental area to avoid any fracture in thin cortical bone, the cervical portion of implant circumference will be decreased by 0.1 to 0.2 mm to avoid pressure resorption of alveolar crest of bone and addition of prepared crown stump for the future crown to be placed. |
| conventional stock root-form titanium implant | Active comparator | Device: Root analog implantUsing a conventional implant as a comparator as it's the gold stander in restoring the non-restorable teeth. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Single rooted teeth indicated for extraction and immediate implant placement.
- The age of candidates ranges from 21 to 50 years.
Key exclusion criteria (2 listed)
- Absence of any disease or systemic complication which might affect osseointegration.
- The cause of extraction mustn't be due to periodontitis or periapical infection.
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 |
|---|---|---|
| Root analog implantAlso: patient specific implanta custom made root analogue implant made from milled titanium | Device | conventional stock root-form titanium implant, root analog implant |
Primary outcome
implant stability
Time frame: 6 months
using periotest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
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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 Root analog implant in people with Implant Stability and Root Analog 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 2 inclusion and 2 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 1 Oct 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?
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 1 Oct 2018.