Dental ImplantsNCT03230500
Computer Guided Versus Free Hand Immediate Implant Placement
A study testing Computer guided implant placement in people with Dental Implants, run by Cairo University at 1 site in Egypt.
Trial summary
Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone will be recruited to the study. After extraction of the tooth implant will be placed immediately, implants will be placed either by free hand or computer guided technique. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Computer guided implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 21 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with teeth or remaining roots in the esthetic zone and indicated for extraction and replacement with immediate implant.
- Sufficient labial bone to avoid labial plate fracture during extraction (at least 1.5-2 mm). This will be confirmed by cone beam computer tomography (CBCT) scan.
- Sufficient mesio distal length between the neighbouring natural teeth (at least 7 mm), this will be confirmed on the study cast.
- Presence of adjacent teeth to the tooth or remaining root to be extracted.
Who cannot join
- Heavy smokers (more than 2 packs / day). Patients with parafunctional habits (e.g. clenching or bruxism, etc.) Presence of acute infection in the tooth or the remaining root that will be extracted.
- Severe overeruption of the opposing teeth to avoid premature contact with the temporary crown during the healing period.
- Patients with poor oral hygiene Pregnant women Any systemic condition that may interfere with implant placement and its osseointegration (as uncontrolled diabetes, chemotherapy, radiotherapy. Osteonecrosis…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction and Early Implant Failure of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, a Randomized Clinical Trial.
Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone will be recruited to the study. After extraction of the tooth implant will be placed immediately, implants will be placed either by free hand or computer guided technique. patient satisfaction will be evaluated as primary outcome and early implant failure was evaluated as secondary outcome.
Read the detailed description
General operative procedures:
Eligible patients will be randomized, at the surgical phase in two groups, study group (in which computer guided implant placement was done using computer aided surgical guide) and comparative group (in which free hand implant placement was done).
Patients of both groups will be subjected to:
Careful clinical examination and medical and dental history taking. CBCT scan will be performed while patients biting on cotton roll to separate the teeth of interest from opposing dentition, moreover cotton rolls will be placed in vestibule for separation of lip and check from teeth of interest.After examination of the CBCT scan, maxillary and mandibular alginate impression will be made for eligible patients.For temporary crown fabrication after the surgery, the tooth or root to be extracted will be modified on the study cast and an artificial tooth will be placed. After that a 2mm hard vacuum sheet will be pressed on the study cast. For the test group (computer guided group), three dimensional (3d) virtual planning of the surgical guide and implant position will be made with the aid of Blue Sky ® implant planning software . After proper selection of implant size, diameter and position, the virtual surgical guide will be exported as a STL file for 3D printing. Before the surgery, adaptation of the surgical guide will be checked on the study cast and a metallic sleeve will be attached at proposed implant position using adhesive.
Intraoperative procedure:
3 days before the surgery, a prophylactic antibiotic will be given to the patient. On the day of surgery, local anaesthesia will be injected and a traumatic extraction of the remaining root or tooth will be performed. For a traumatic extraction, gentle application of a periotome mesio-distally along with slight rotational movement. After extraction, intact labial and palatal socket walls will be checked using periodontal probe for immediate implant placement. For the test group, the computer aided surgical guide will be checked for adaptability and any interference will be removed. After that implant drilling and placement will be performed using the surgical guide. For the control group, free hand implant drilling and placement will be performed guided by the extraction socket walls. For both groups implant primary stability will be checked by application of 35 Ncm2 force using torque wrench After that, the final abutment will be screwed in its position and the temporary crown will be made using the vacuum stent, where a chair side tooth coloured autopolymerizing resin will be injected into the vacuum stent at the proposed implant site. Finally, occlusion will be checked for any functional contact in maximum intercuspation and lateral movement. Any contact with the opposing should be removed and the patient will be instructed to avoid eating or incising on the temporary crown for at least two weeks. Seven days later patients will be recalled for inspection and taking postoperative photos, six months thereafter, the patient will receive a definitive crown.
- Conditions
- Dental Implants
- Being tested
- Computer guided implant placement
- Keywords
- computer guided, immediate implant, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer guided implant placementProcedure or surgery
Implant will be placed immediately using computer aided surgical guide
| Study group | Role | What they receive |
|---|---|---|
| Computer guided immediate implant placement | Experimental | For the test group, the computer aided surgical guide will be used for implant drilling and placement. Receives: Procedure: Computer guided implant placement |
| Free hand immediate implant placement | Active comparator | For the control group, free hand implant drilling and placement will be performed guided by the extraction socket walls. Receives: Procedure: Computer guided implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction will be assessed through a questionnaire and each question of the questionnaire will be scored by the patients on 10 cm visual analogue scales (VAS)
Measured: 0-6 months
Secondary outcomes (1)
Early implant failure
Early implant failure will be clinically diagnosed by implant loss from mouth which will be detected by visual inspection. Early implant failure will be assessed in the interval between implant placement until functional loading (0-6 months).
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Feb 2019
- Primary completion1 Dec 2019
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Kamel Hussein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230500
- Sponsor's protocol ID
- Faculty of Dentistry
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2017
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schropp L, Isidor F, Kostopoulos L, Wenzel A. Patient experience of, and satisfaction with, delayed-immediate vs. delayed single-tooth implant placement. Clin Oral Implants Res. 2004 Aug;15(4):498-503. doi: 10.1111/j.1600-0501.2004.01033.x.
PubMed 15248886Misch CE, Perel ML, Wang HL, Sammartino G, Galindo-Moreno P, Trisi P, Steigmann M, Rebaudi A, Palti A, Pikos MA, Schwartz-Arad D, Choukroun J, Gutierrez-Perez JL, Marenzi G, Valavanis DK. Implant success, survival, and failure: the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dent. 2008 Mar;17(1):5-15. doi: 10.1097/ID.0b013e3181676059.
PubMed 18332753Sabir M, Alam MN. Survival of Implants in Immediate Extraction Sockets of Anterior Teeth: Early Clinical Results. J Clin Diagn Res. 2015 Jun;9(6):ZC58-61. doi: 10.7860/JCDR/2015/13631.6123. Epub 2015 Jun 1.
PubMed 26266220
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Early Implant Failure of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03230500
- Acronym / sponsor ID
- Faculty of Dentistry
- Conditions
- Dental Implants
- Keywords
- computer guided, immediate implant, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 26 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.
Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone will be recruited to the study. After extraction of the tooth implant will be placed immediately, implants will be placed either by free hand or computer guided technique. patient satisfaction will be evaluated as primary outcome and early implant failure was evaluated as secondary outcome.
Detailed description
General operative procedures:
Eligible patients will be randomized, at the surgical phase in two groups, study group (in which computer guided implant placement was done using computer aided surgical guide) and comparative group (in which free hand implant placement was done).
Patients of both groups will be subjected to:
Careful clinical examination and medical and dental history taking. CBCT scan will be performed while patients biting on cotton roll to separate the teeth of interest from opposing dentition, moreover cotton rolls will be placed in vestibule for separation of lip and check from teeth of interest.After examination of the CBCT scan, maxillary and mandibular alginate impression will be made for eligible patients.For temporary crown fabrication after the surgery, the tooth or root to be extracted will be modified on the study cast and an artificial tooth will be placed. After that a 2mm hard vacuum sheet will be pressed on the study cast. For the test group (computer guided group), three dimensional (3d) virtual planning of the surgical guide and implant position will be made with the aid of Blue Sky ® implant planning software . After proper selection of implant size, diameter and position, the virtual surgical guide will be exported as a STL file for 3D printing. Before the surgery, adaptation of the surgical guide will be checked on the study cast and a metallic sleeve will be attached at proposed implant position using adhesive.
Intraoperative procedure:
3 days before the surgery, a prophylactic antibiotic will be given to the patient. On the day of surgery, local anaesthesia will be injected and a traumatic extraction of the remaining root or tooth will be performed. For a traumatic extraction, gentle application of a periotome mesio-distally along with slight rotational movement. After extraction, intact labial and palatal socket walls will be checked using periodontal probe for immediate implant placement. For the test group, the computer aided surgical guide will be checked for adaptability and any interference will be removed. After that implant drilling and placement will be performed using the surgical guide. For the control group, free hand implant drilling and placement will be performed guided by the extraction socket walls. For both groups implant primary stability will be checked by application of 35 Ncm2 force using torque wrench After that, the final abutment will be screwed in its position and the temporary crown will be made using the vacuum stent, where a chair side tooth coloured autopolymerizing resin will be injected into the vacuum stent at the proposed implant site. Finally, occlusion will be checked for any functional contact in maximum intercuspation and lateral movement. Any contact with the opposing should be removed and the patient will be instructed to avoid eating or incising on the temporary crown for at least two weeks. Seven days later patients will be recalled for inspection and taking postoperative photos, six months thereafter, the patient will receive a definitive crown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Computer guided immediate implant placement | Experimental | Procedure: Computer guided implant placementFor the test group, the computer aided surgical guide will be used for implant drilling and placement. |
| Free hand immediate implant placement | Active comparator | Procedure: Computer guided implant placementFor the control group, free hand implant drilling and placement will be performed guided by the extraction socket walls. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with teeth or remaining roots in the esthetic zone and indicated for extraction and replacement with immediate implant.
- Sufficient labial bone to avoid labial plate fracture during extraction (at least 1.5-2 mm). This will be confirmed by cone beam computer tomography (CBCT) scan.
- Sufficient mesio distal length between the neighbouring natural teeth (at least 7 mm), this will be confirmed on the study cast.
- Presence of adjacent teeth to the tooth or remaining root to be extracted.
Key exclusion criteria (3 listed)
- Heavy smokers (more than 2 packs / day). Patients with parafunctional habits (e.g. clenching or bruxism, etc.) Presence of acute infection in the tooth or the remaining root that will be extracted.
- Severe overeruption of the opposing teeth to avoid premature contact with the temporary crown during the healing period.
- Patients with poor oral hygiene Pregnant women Any systemic condition that may interfere with implant placement and its osseointegration (as uncontrolled diabetes, chemotherapy, radiotherapy. Osteonecrosis…)
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 |
|---|---|---|
| Computer guided implant placementImplant will be placed immediately using computer aided surgical guide | Procedure or surgery | Computer guided immediate implant placement, Free hand immediate implant placement |
Primary outcome
Patient satisfaction
Time frame: 0-6 months
Patient satisfaction will be assessed through a questionnaire and each question of the questionnaire will be scored by the patients on 10 cm visual analogue scales (VAS)
1 secondary outcome
Early implant failure
Time frame: 0-6 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 22 Jul 2020.
- Background: PubMed 15248886Schropp L, Isidor F, Kostopoulos L, Wenzel A. Patient experience of, and satisfaction with, delayed-immediate vs. delayed single-tooth implant placement. Clin Oral Implants Res. 2004 Aug;15(4):498-503. doi: 10.1111/j.1600-0501.2004.01033.x.
- Background: PubMed 18332753Misch CE, Perel ML, Wang HL, Sammartino G, Galindo-Moreno P, Trisi P, Steigmann M, Rebaudi A, Palti A, Pikos MA, Schwartz-Arad D, Choukroun J, Gutierrez-Perez JL, Marenzi G, Valavanis DK. Implant success, survival, and failure: the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dent. 2008 Mar;17(1):5-15. doi: 10.1097/ID.0b013e3181676059.
- Results publication: PubMed 26266220Sabir M, Alam MN. Survival of Implants in Immediate Extraction Sockets of Anterior Teeth: Early Clinical Results. J Clin Diagn Res. 2015 Jun;9(6):ZC58-61. doi: 10.7860/JCDR/2015/13631.6123. Epub 2015 Jun 1.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer guided implant placement in people with Dental Implants, run by Cairo University 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 4 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: finished, as of the sponsor's last update on 22 Jul 2020. 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?
Patient satisfaction (time frame: 0-6 months). 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 NCT03230500, which also lists 3 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 22 Jul 2020.