Immediate Dental ImplantsNCT03243695
Influence of Abutment Angulation on Implant Failure in Immediately Placed and Restored Implants in the Esthetic Zone Using Computer Aided Surgical Guides: RCT
A study testing Angled Abutment and straight abutment in people with Immediate Dental Implants, run by Cairo University at 1 site in Egypt.
Trial summary
patients with fractured teeth in the esthetic area requiring immediate restoration will be recruited to the study. Immediate implants will be placed and patients will be restored either with straight or angled abutments. Implant failure will be measured. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implants
- What is being tested?
- Angled Abutment and straight abutment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 30 Dec 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 50 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 Presence of adjacent natural teeth to the tooth/teeth to be extracted
Who cannot join
- Presence of active signs 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) Severe overeruption of the opposing teeth to avoid any premature contact with the temporary crown during the osseointegration period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implant Failure When Using Angled Versus Straight Abutments in Immediately Placed and Restored Implants in the Esthetic Zone Using Computer Aided Surgical Guides:A Randomized Clinical Trial
patients with fractured teeth in the esthetic area requiring immediate restoration will be recruited to the study. Immediate implants will be placed and patients will be restored either with straight or angled abutments. Implant failure will be measured.
Read the detailed description
A: General operative procedures:
The study will be explained in details to the eligible participants with all possible alternative treatment options and possible risk.
If a patient accepts the treatment, informed consent will be signed. Standard extra oral and intraoral examination will be carried out. Diagnostic charts will be filled including medical and past dental history.
The patient will choose a sealed envelope to determine the allocation group. Preliminary impressions will be taken. The tooth to be extracted will be trimmed from the cast and an ideal wax up will be done.
A hard vacuum stent 2 mm thickness will be constructed over the cast with the wax up for fabrication of the temporary crown later.
The patient will be imaged a cone beam computerized topography (CBCT). The acquired DICOM image will be assessed on blue sky software ®. All the cases must have adequate buccolingual bone, if not the patient will be excluded from the study.
The co-supervisor (MW) will inform the principle investigator (HF) with the allocation group.
The principle investigator (HF) will plan the case. The implants will be planned apical to socket depth to engage apical bone for better primary stability. Final implant position 3 dimensionally will be according to allocation group to allow for placement of either straight or angled abutment.
The guide will be exported from the software and printed.
Intra operative procedures:
Patients will administrate a prophylactic antibiotic 3 days ahead the surgery. The procedure will be carried out under local anesthesia under sterile conditions.
The remaining tooth will be extracted atraumatically using periotome for better bone preservation.
After tooth extraction, the socket will be curettaged and irrigated with copious saline till fresh bleeding from the socket is observed.
Surgical guide will be placed and checked for stability and drilling will be performed following instructions.
Before implant insertion, the prepared osteotomy will be lavaged thoroughly to remove any drill debris from the socket.
The implant will be placed and the insertion torque will be checked using manual torque wrench. Implants with insertion torque less than 35Ncm will not be loaded and will be excluded from the study.
Periapical radiographs will be taken to ensure proper seating of the implant. The abutment, whether straight or angled according to the allocation group, will be attached to the implant fixture.
The vacuum stent will be used to perform the temporary crown using autopolymerizing resin. The crown will be checked to be out of occlusion in centric and eccentric occlusion to avoid any premature contact and subsequent overloading. Then the crown will be cemented and excess cement will be removed using dental floss.
The patient will be called for follow up after 1 week for the first 3 weeks then at 1 month and 3 months.
- Conditions
- Immediate Dental Implants
- Being tested
- Angled Abutment, straight abutment
- Keywords
- immediate implants, implant failure, angled abutments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angled AbutmentOther
virtual implants will be placed on a planning software allowing abutments to be placed at an angle to the implant. Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide. The angled abutment will be placed and a temporary crown material will be fabricated.
straight abutmentOther
virtual implants will be placed on a planning software allowing abutments to be placed at straight to the implant. Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide. The straight abutment will be placed and a temporary crown material will be fabricated.
| Study group | Role | What they receive |
|---|---|---|
| Angled abutment | Experimental | According to the allocation, the experimental group will receive an angled abutment on the immediately placed implant. A vaccum stent will be used to fabricate a temporary crown using tooth colored auto-polymerizing resin(structur 2 SC/ QM , VOCO GmbH, Germany) Receives: Other: Angled Abutment |
| Straight abutment | Active comparator | According to the allocation, the control group will receive on the immediately placed implant a Straight zero degree abutment . A vaccum stent will be used to fabricate a temporary crown using tooth colored auto-polymerizing resin(structur 2 SC/ QM , VOCO GmbH, Germany) Receives: Other: straight abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant failure
clinical observation
Measured: 3 months interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start1 Jan 2018
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
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 Immediate 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Fakhry Fouad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243695
- Sponsor's protocol ID
- Prosth department
- Status last verified
- Jun 2020
- First submitted
- 4 Aug 2017
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Araújo, M.G. et al., 2005. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. Journal of clinical periodontology, 32(6), pp.645-52. Brosh, T., Pilo, R. & Sudai, D., 1998. The influence of abutment angulation on strains and stresses along the implant/bone interface: comparison between two experimental techniques. The Journal of prosthetic dentistry, 79(3), pp.328-34. Chrcanovic, B.R., Albrektsson, T. & Wennerberg, A., 2015. Tilted versus axially placed dental implants: a meta-analysis. Journal of dentistry, 43(2), pp.149-70. Del Fabbro, M. et al., 2015. Immediate loading of postextraction implants in the esthetic area: systematic review of the literature. Clinical implant dentistry and related research, 17(1), pp.52-70.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant Failure When Using Angled Versus Straight Abutments in Immediately Placed and Restored Implants in the Esthetic Zone Using Computer Aided Surgical Guides:A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03243695
- Acronym / sponsor ID
- Prosth department
- Conditions
- Immediate Dental Implants
- Keywords
- immediate implants, implant failure, angled abutments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 9 Aug 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 teeth in the esthetic area requiring immediate restoration will be recruited to the study. Immediate implants will be placed and patients will be restored either with straight or angled abutments. Implant failure will be measured.
Detailed description
A: General operative procedures:
The study will be explained in details to the eligible participants with all possible alternative treatment options and possible risk.
If a patient accepts the treatment, informed consent will be signed. Standard extra oral and intraoral examination will be carried out. Diagnostic charts will be filled including medical and past dental history.
The patient will choose a sealed envelope to determine the allocation group. Preliminary impressions will be taken. The tooth to be extracted will be trimmed from the cast and an ideal wax up will be done.
A hard vacuum stent 2 mm thickness will be constructed over the cast with the wax up for fabrication of the temporary crown later.
The patient will be imaged a cone beam computerized topography (CBCT). The acquired DICOM image will be assessed on blue sky software ®. All the cases must have adequate buccolingual bone, if not the patient will be excluded from the study.
The co-supervisor (MW) will inform the principle investigator (HF) with the allocation group.
The principle investigator (HF) will plan the case. The implants will be planned apical to socket depth to engage apical bone for better primary stability. Final implant position 3 dimensionally will be according to allocation group to allow for placement of either straight or angled abutment.
The guide will be exported from the software and printed.
Intra operative procedures:
Patients will administrate a prophylactic antibiotic 3 days ahead the surgery. The procedure will be carried out under local anesthesia under sterile conditions.
The remaining tooth will be extracted atraumatically using periotome for better bone preservation.
After tooth extraction, the socket will be curettaged and irrigated with copious saline till fresh bleeding from the socket is observed.
Surgical guide will be placed and checked for stability and drilling will be performed following instructions.
Before implant insertion, the prepared osteotomy will be lavaged thoroughly to remove any drill debris from the socket.
The implant will be placed and the insertion torque will be checked using manual torque wrench. Implants with insertion torque less than 35Ncm will not be loaded and will be excluded from the study.
Periapical radiographs will be taken to ensure proper seating of the implant. The abutment, whether straight or angled according to the allocation group, will be attached to the implant fixture.
The vacuum stent will be used to perform the temporary crown using autopolymerizing resin. The crown will be checked to be out of occlusion in centric and eccentric occlusion to avoid any premature contact and subsequent overloading. Then the crown will be cemented and excess cement will be removed using dental floss.
The patient will be called for follow up after 1 week for the first 3 weeks then at 1 month and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angled abutment | Experimental | Other: Angled AbutmentAccording to the allocation, the experimental group will receive an angled abutment on the immediately placed implant. A vaccum stent will be used to fabricate a temporary crown using tooth colored auto-polymerizing resin(structur 2 SC/ QM , VOCO GmbH, Germany) |
| Straight abutment | Active comparator | Other: straight abutmentAccording to the allocation, the control group will receive on the immediately placed implant a Straight zero degree abutment . A vaccum stent will be used to fabricate a temporary crown using tooth colored auto-polymerizing resin(structur 2 SC/ QM , VOCO GmbH, Germany) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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 Presence of adjacent natural teeth to the tooth/teeth to be extracted
Key exclusion criteria (1 listed)
- Presence of active signs 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) Severe overeruption of the opposing teeth to avoid any premature contact with the temporary crown during the osseointegration period.
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 |
|---|---|---|
| Angled Abutmentvirtual implants will be placed on a planning software allowing abutments to be placed at an angle to the implant. Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide. The angled abutment will be placed and a temporary crown material will be fabricated. | Other | Angled abutment |
| straight abutmentvirtual implants will be placed on a planning software allowing abutments to be placed at straight to the implant. Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide. The straight abutment will be placed and a temporary crown material will be fabricated. | Other | Straight abutment |
Primary outcome
Implant failure
Time frame: 3 months interval
clinical observation
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 9 Jun 2020.
- BackgroundAraújo, M.G. et al., 2005. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. Journal of clinical periodontology, 32(6), pp.645-52. Brosh, T., Pilo, R. & Sudai, D., 1998. The influence of abutment angulation on strains and stresses along the implant/bone interface: comparison between two experimental techniques. The Journal of prosthetic dentistry, 79(3), pp.328-34. Chrcanovic, B.R., Albrektsson, T. & Wennerberg, A., 2015. Tilted versus axially placed dental implants: a meta-analysis. Journal of dentistry, 43(2), pp.149-70. Del Fabbro, M. et al., 2015. Immediate loading of postextraction implants in the esthetic area: systematic review of the literature. Clinical implant dentistry and related research, 17(1), pp.52-70.
- 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 Angled Abutment and straight abutment in people with Immediate 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 1 inclusion and 1 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 9 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?
Implant failure (time frame: 3 months interval). 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 NCT03243695, 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 9 Jun 2020.