Dental ImplantRCTNCT03211819
Computer-guided Versus Free- Hand Immediate Implant Placement
A study testing immediate implant placement in people with Dental Implant, run by Cairo University at 1 site in Egypt.
Trial summary
Patients with fractured anterior teeth indicated for extraction will be recruited to the study. After Extraction of the tooth the socket will be evaluated and if eligible for immediate implant placement, 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 Implant
- What is being tested?
- immediate 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
- 15 Feb 2019to 1 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 indicated for extraction in the esthetic zone and eligible for immediate implant placement
- Sufficient bone labially (at least 1.5-2 mm) assessed after cone beam computer tomography (CBCT) scan
- Presence of adequate mesio-distal length between the adjacent natural teeth (at least 7 mm), measured on the study cast
- No overeruption of the opposing teeth to avoid any premature contact with the temporary crown during the osseointegration period.
Who cannot join
- Presence of active sings or symptoms of acute infection in the tooth or the remaining root
- Heavy smokers (more than 2 packs per day)
- Parafunctional habits (clenching or bruxism) diagnosed by history taking and observation of the occlusal surface of the posterior teeth for wear facets
- Patients with poor oral hygiene
- Pregnant women
- Any systemic condition that may interfere with osseointegration (as uncontrolled diabetes, recent head and neck radiation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esthetic Outcome of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, a Randomized Clinical Trial.
Patients with fractured anterior teeth indicated for extraction will be recruited to the study. After Extraction of the tooth the socket will be evaluated and if eligible for immediate implant placement, implants will be placed either by free hand or computer guided technique. The pink esthetic score will be evaluated to be the primary outcome.
Read the detailed description
After diagnosis and history taking the patient will be informed about the sequences of the trial. If the patient wishes to participate and fulfills the clinical examination inclusion criteria, he/she will be sent to perform a Cone Beam Computer Tomography (CBCT) scan while biting on a cotton roll and placing cotton rolls in the vestibule to separate the teeth of interest from the opposing dentition and lips respectively.
Then the investigator will examine the CBCT to ensure the presence of sufficient labial bone. Only patients with sufficient labial bone (1.5-2 mm) will be included in the study. If the patient has less than 1.5 mm labial bone, he/she won't be eligible for immediate implant placement and would be referred to delayed implant placement.
The eligible patients will be recalled for impression making. The principal investigator will do a vacuum stent (2mm hard) on the obtained study cast for temporary crown fabrication after the surgery. The tooth or root to be extracted will be modified on the cast and an artificial tooth would be placed then the vacuum sheet will be pressed on the cast.
At this appointment (impression making) the patient will choose a sealed envelope containing the allocation either to the computer guided group (test group) or free hand group (control group). The patient's name will be written on the envelope to avoid changing the randomization process.
For the test group, the principal investigator (AK) will do virtual planning using Blue Sky ® implant planning software. Proper implant size and diameter will be used and a virtual surgical guide will be constructed in a Standard Triangulation Language (STL) format and exported to a 3D printing machine for printing. After printing the guide would be rechecked for adaptation on the study cast. A metallic sleeve will be placed and adapted to the surgical guide in the proposed implant site, using adhesive to avoid rotation during surgery.
Surgical procedure:
A prophylactic antibiotic would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome, minimal force and rotational movement.
After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement.
In the test group, the computer guided surgical guide will be used for implant drilling and placement following the manufacture's instructions.
While in the control group, after tooth or root extraction implants will be placed free hand guided by the extraction sockets.
Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and re-positioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth colored auto-polymerizing resin will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown.
Then occlusion will be checked in maximum intercuspation and lateral movement to avoid any contact with the opposing during the healing period. The patient will be instructed to avoid eating or incising any hard food in the surgical site for at least two weeks.
After a week the patient will be recalled for inspection and postoperative photos to be taken for outcome assessment for both groups. And finally after a period of 6 months the patient would receive a definitive crown.
- Conditions
- Dental Implant
- Being tested
- immediate implant placement
- Keywords
- immediate, esthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placementProcedure or surgery
A prophylactic antibiotic(Flumox 500mg, Egyptian Int. Pharmaceutical Industries Co.,A.R.E.) would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome (Nordent Manufacturing Inc. U.S.A), minimal force and rotational movement.
After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement.
| Study group | Role | What they receive |
|---|---|---|
| computer guided placement | Experimental | In the test group, the computer guided surgical guide manufactured using zenith 3D printer (Dentis, Daegu, Korea) will be used for implant drilling and placement (s-Clean Tapered Implants, Dentis Co., Ltd., Woram-Dong, Dalseo-Gu, Daegu, South Korea) following the manufacture's instructions.
Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and repositioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth coloured autopolymerizing resin (Structur 2 SC / QM,VOCO GmbH, Germany) will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown. Receives: Procedure: immediate implant placement |
| free hand placement | Active comparator | in the control group, the implant will be placed it the socket using free hand technique and according to the manufacturing instruction's (s-Clean Tapered Implants, Dentis Co., Ltd., Woram-Dong, Dalseo-Gu, Daegu, South Korea) . The implants will be placed guided by the socket of the root. Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and repositioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth coloured autopolymerizing resin (Structur 2 SC / QM,VOCO GmbH,Germany)will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown. Receives: Procedure: immediate implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink Esthetic Score (PES)
a scoring system of five points are to be checked and evaluated where 0=incomplete; 1= partially present; 2= completely present
Measured: 1 week postoperative to surgery
Pink Esthetic Score (PES)
a scoring system of five points are to be checked and evaluated where 0=incomplete; 1= partially present; 2= completely present
Measured: 1 week postoperative to definitive crown
Secondary outcomes (1)
Gingival recession
yes/no
Measured: 1 week and 6 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start15 Feb 2019
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies 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
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kotb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211819
- Sponsor's protocol ID
- Prosthodontic Department
- Acronym
- RCT
- Status last verified
- Jun 2020
- First submitted
- 6 Jul 2017
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arisan V, Karabuda CZ, Mumcu E, Ozdemir T. Implant positioning errors in freehand and computer-aided placement methods: a single-blind clinical comparative study. Int J Oral Maxillofac Implants. 2013 Jan-Feb;28(1):190-204. doi: 10.11607/jomi.2691.
PubMed 23377066
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Outcome of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03211819
- Acronym / sponsor ID
- RCT / Prosthodontic Department
- Conditions
- Dental Implant
- Keywords
- immediate, esthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 7 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 fractured anterior teeth indicated for extraction will be recruited to the study. After Extraction of the tooth the socket will be evaluated and if eligible for immediate implant placement, implants will be placed either by free hand or computer guided technique. The pink esthetic score will be evaluated to be the primary outcome.
Detailed description
After diagnosis and history taking the patient will be informed about the sequences of the trial. If the patient wishes to participate and fulfills the clinical examination inclusion criteria, he/she will be sent to perform a Cone Beam Computer Tomography (CBCT) scan while biting on a cotton roll and placing cotton rolls in the vestibule to separate the teeth of interest from the opposing dentition and lips respectively.
Then the investigator will examine the CBCT to ensure the presence of sufficient labial bone. Only patients with sufficient labial bone (1.5-2 mm) will be included in the study. If the patient has less than 1.5 mm labial bone, he/she won't be eligible for immediate implant placement and would be referred to delayed implant placement.
The eligible patients will be recalled for impression making. The principal investigator will do a vacuum stent (2mm hard) on the obtained study cast for temporary crown fabrication after the surgery. The tooth or root to be extracted will be modified on the cast and an artificial tooth would be placed then the vacuum sheet will be pressed on the cast.
At this appointment (impression making) the patient will choose a sealed envelope containing the allocation either to the computer guided group (test group) or free hand group (control group). The patient's name will be written on the envelope to avoid changing the randomization process.
For the test group, the principal investigator (AK) will do virtual planning using Blue Sky ® implant planning software. Proper implant size and diameter will be used and a virtual surgical guide will be constructed in a Standard Triangulation Language (STL) format and exported to a 3D printing machine for printing. After printing the guide would be rechecked for adaptation on the study cast. A metallic sleeve will be placed and adapted to the surgical guide in the proposed implant site, using adhesive to avoid rotation during surgery.
Surgical procedure:
A prophylactic antibiotic would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome, minimal force and rotational movement.
After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement.
In the test group, the computer guided surgical guide will be used for implant drilling and placement following the manufacture's instructions.
While in the control group, after tooth or root extraction implants will be placed free hand guided by the extraction sockets.
Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and re-positioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth colored auto-polymerizing resin will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown.
Then occlusion will be checked in maximum intercuspation and lateral movement to avoid any contact with the opposing during the healing period. The patient will be instructed to avoid eating or incising any hard food in the surgical site for at least two weeks.
After a week the patient will be recalled for inspection and postoperative photos to be taken for outcome assessment for both groups. And finally after a period of 6 months the patient would receive a definitive crown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer guided placement | Experimental | Procedure: immediate implant placementIn the test group, the computer guided surgical guide manufactured using zenith 3D printer (Dentis, Daegu, Korea) will be used for implant drilling and placement (s-Clean Tapered Implants, Dentis Co., Ltd., Woram-Dong, Dalseo-Gu, Daegu, South Korea) following the manufacture's instructions. Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and repositioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth coloured autopolymerizing resin (Structur 2 SC / QM,VOCO GmbH, Germany) will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown. |
| free hand placement | Active comparator | Procedure: immediate implant placementin the control group, the implant will be placed it the socket using free hand technique and according to the manufacturing instruction's (s-Clean Tapered Implants, Dentis Co., Ltd., Woram-Dong, Dalseo-Gu, Daegu, South Korea) . The implants will be placed guided by the socket of the root. Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and repositioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth coloured autopolymerizing resin (Structur 2 SC / QM,VOCO GmbH,Germany)will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown. |
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 indicated for extraction in the esthetic zone and eligible for immediate implant placement
Key exclusion criteria (6 listed)
- Presence of active sings or symptoms of acute infection in the tooth or the remaining root
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 |
|---|---|---|
| immediate implant placementA prophylactic antibiotic(Flumox 500mg, Egyptian Int. Pharmaceutical Industries Co.,A.R.E.) would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome (Nordent Manufacturing Inc. U.S.A), minimal force and rotational movement. After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement. | Procedure or surgery | computer guided placement, free hand placement |
Primary outcome
Pink Esthetic Score (PES)
Time frame: 1 week postoperative to surgery
a scoring system of five points are to be checked and evaluated where 0=incomplete; 1= partially present; 2= completely present
Pink Esthetic Score (PES)
Time frame: 1 week postoperative to definitive crown
a scoring system of five points are to be checked and evaluated where 0=incomplete; 1= partially present; 2= completely present
1 secondary outcome
Gingival recession
Time frame: 1 week and 6 month postoperatively
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 5 Jun 2020.
- Background: PubMed 23377066Arisan V, Karabuda CZ, Mumcu E, Ozdemir T. Implant positioning errors in freehand and computer-aided placement methods: a single-blind clinical comparative study. Int J Oral Maxillofac Implants. 2013 Jan-Feb;28(1):190-204. doi: 10.11607/jomi.2691.
- 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 immediate implant placement in people with Dental Implant, 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 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 5 Jun 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?
Pink Esthetic Score (PES) (time frame: 1 week postoperative to surgery). The study lists 2 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 NCT03211819, which also lists 1 linked publication.
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 5 Jun 2020.