Immediate Implant Placement Guided by the Roots of Multiradicular TeethNCT04192461
Accuracy of Tooth Guided Immediate Implant Placement at Molar Region
A study testing Tooth guided immediate implant placement in people with Immediate Implant Placement Guided by the Roots of Multiradicular Teeth, run by Abdelrhman Tarek Sahry Abdelazim at 1 site in Egypt.
Trial summary
Introduction: The concept of immediate implant placement has become popular due to reduced trauma and reduced overall treatment time. Removal of molar teeth provides a challenging and intriguing dilemma due to multiple root morphology. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant Placement Guided by the Roots of Multiradicular Teeth
- What is being tested?
- Tooth guided immediate implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2018to 10 Oct 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Badly destructed mandibular molar teeth.
- Integrity of the roots.
- Bone coverage of 2/3 of the root.
- Sufficient bone volume.
- Adequate interocclusal distance >7mm.
- Adequate amount of keratinized mucosa.
- Age ranging from 20-45 years.
- Medically fit patients.
Who cannot join
- Unfavorable position of the tooth or remaining roots.
- Molars with Fused roots.
- Root ankylosis.
- Patients with systemic conditions known to affect the periodontal status and healing such as uncontrolled diabetes and osteoporosis.
- Patients receiving chemotherapy or radiotherapy.
- Heavy smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: The concept of immediate implant placement has become popular due to reduced trauma and reduced overall treatment time. Removal of molar teeth provides a challenging and intriguing dilemma due to multiple root morphology. In cases of extraction and immediate placement of implants in the molar region, removal of the inter-radicular septum should be avoided to attain initial implant stability at the time of placement, and prevent slipping of the implant into the extraction socket. Following this technique prevents the slippage of the implant and allows the implant to be guided into the inter-radicular septum.
Objectives: To assess the accuracy of implant placement using the remaining roots of multi-radicular mandibular molars, evaluate bone density around implants and implant stability in fresh extracted site.
Materials and Methods: A prospective study was done on 10 patients with badly destructed mandibular molars. The technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the multi-radicular mandibular molars to be extracted as a reference and as an aid to engage the inter-radicular septum.
- Being tested
- Tooth guided immediate implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth guided immediate implant placementProcedure or surgery
The technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the multi-radicular mandibular molars to be extracted as a reference and as an aid to engage the inter-radicular septum
| Study group | Role | What they receive |
|---|---|---|
| tooth guided immediate implant placement group | Experimental | Not described Receives: Procedure: Tooth guided immediate implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability quotient
implant stability quotient will be assessed using Osstell device.
Measured: 3 months
Implant position accuracy using cone beam computed tomography
Immediate postoperative and a preoperative conebeam CT will be done. The preoperative and postoperative scans will then be over¬lapped using a dedicated algorithm, which will allow the comparison of the virtually planned and the actual implant positions. Three deviation parameters between each planned and placed implant will be measured. All measurements will be performed using Mimics Innovation Suite 19 ™ software (Materialise Mimics software 3D Medical Imaging, Belgium).
For analyzing the accuracy, the planned position of the implant will be compared with the actual position of the implant after insertion. Several measuring points will be measured:
- Horizontal deviation at coronal side of the implant.
- Horizontal deviation at apex of the implant.
- Angular deviation.
Measured: immediately
Bone density around implant
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 posted10 Dec 2019
- Study start15 Jun 2018
- Primary completion15 Oct 2018
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immediate Implant Placement Guided by the Roots of Multiradicular TeethStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdelrhman Tarek Sahry Abdelazim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrhman Tarek Sahry Abdelazim, Alexandria University
- Investigators
- Samraa Elsheikh, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192461
- Sponsor's protocol ID
- Tooth guided immediate implant
- Status last verified
- Dec 2019
- First submitted
- 5 Dec 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mahesh L, Kurtzman GM, Schwartz D, Shukla S. Residual Roots as an Anatomical Guide for Implant Placement: Case Series With Two-Year Follow-up. J Oral Implantol. 2016 Jun;42(3):285-8. doi: 10.1563/aaid-joi-D-15-00101. Epub 2015 Sep 21.
PubMed 26389698Rodriguez-Tizcareno MH, Bravo-Flores C. Anatomically guided implant site preparation technique at molar sites. Implant Dent. 2009 Oct;18(5):393-401. doi: 10.1097/ID.0b013e3181b4b205.
PubMed 22129957
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Tooth Guided Immediate Implant Placement at Molar Region
- ClinicalTrials.gov ID
- NCT04192461
- Acronym / sponsor ID
- Tooth guided immediate implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Abdelrhman Tarek Sahry AbdelazimUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 10 Dec 2019 (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.
Introduction: The concept of immediate implant placement has become popular due to reduced trauma and reduced overall treatment time. Removal of molar teeth provides a challenging and intriguing dilemma due to multiple root morphology. In cases of extraction and immediate placement of implants in the molar region, removal of the inter-radicular septum should be avoided to attain initial implant stability at the time of placement, and prevent slipping of the implant into the extraction socket. Following this technique prevents the slippage of the implant and allows the implant to be guided into the inter-radicular septum.
Objectives: To assess the accuracy of implant placement using the remaining roots of multi-radicular mandibular molars, evaluate bone density around implants and implant stability in fresh extracted site.
Materials and Methods: A prospective study was done on 10 patients with badly destructed mandibular molars. The technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the multi-radicular mandibular molars to be extracted as a reference and as an aid to engage the inter-radicular septum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tooth guided immediate implant placement group | Experimental | Procedure: Tooth guided immediate implant placement |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Badly destructed mandibular molar teeth.
- Integrity of the roots.
- Bone coverage of 2/3 of the root.
- Sufficient bone volume.
- Adequate interocclusal distance >7mm.
Key exclusion criteria (6 listed)
- Unfavorable position of the tooth or remaining roots.
- Molars with Fused roots.
- Root ankylosis.
- Patients with systemic conditions known to affect the periodontal status and healing such as uncontrolled diabetes and osteoporosis.
- Patients receiving chemotherapy or radiotherapy.
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 |
|---|---|---|
| Tooth guided immediate implant placementThe technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the multi-radicular mandibular molars to be extracted as a reference and as an aid to engage the inter-radicular septum | Procedure or surgery | tooth guided immediate implant placement group |
Primary outcome
implant stability quotient
Time frame: 3 months
implant stability quotient will be assessed using Osstell device.
Implant position accuracy using cone beam computed tomography
Time frame: immediately
Immediate postoperative and a preoperative conebeam CT will be done. The preoperative and postoperative scans will then be over¬lapped using a dedicated algorithm, which will allow the comparison of the virtually planned and the actual implant positions. Three deviation parameters between each planned and placed implant will be measured. All measurements will be performed using Mimics Innovation Suite 19 ™ software (Materialise Mimics software 3D Medical Imaging, Belgium). For analyzing the accuracy, the planned position of the implant will be compared with the actual position of the implant after insertion. Several measuring points will be measured: * Horizontal deviation at coronal side of the implant. * Horizontal deviation at apex of the implant. * Angular deviation.
Bone density around implant
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Background: PubMed 26389698Mahesh L, Kurtzman GM, Schwartz D, Shukla S. Residual Roots as an Anatomical Guide for Implant Placement: Case Series With Two-Year Follow-up. J Oral Implantol. 2016 Jun;42(3):285-8. doi: 10.1563/aaid-joi-D-15-00101. Epub 2015 Sep 21.
- Background: PubMed 22129957Rodriguez-Tizcareno MH, Bravo-Flores C. Anatomically guided implant site preparation technique at molar sites. Implant Dent. 2009 Oct;18(5):393-401. doi: 10.1097/ID.0b013e3181b4b205.
- Individual participant dataSharing planned: Undecided
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.
Samraa Elsheikh, PhD study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth guided immediate implant placement in people with Immediate Implant Placement Guided by the Roots of Multiradicular Teeth, run by Abdelrhman Tarek Sahry Abdelazim at 1 site in Egypt.
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 8 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: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 quotient (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04192461, which also lists 2 linked publications.
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 10 Dec 2019.