Implant TherapyPhase 2NCT06791655
Customized CAD/CAM Titanium-Milled Abutments Vs. Custom Abutments Over Immediate Implants in Class II Extraction Sockets in the Esthetic Zone: a Randomized Controlled Clinical Trial
A Phase 2 study testing Stock Abutment Implant and Customized CAD CAM Titanium Milled Abutment Implant in people with Implant Therapy and Class II Extraction Sockets, run by Ain Shams University at 1 site in Egypt.
Trial summary
Background: Immediate implant placement in esthetic zones, particularly Class II and III extraction sockets, presents challenges related to soft and hard tissue changes post-extraction. Customized abutments may offer advantages over stock abutments in managing these changes and improving clinical outcomes. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Implant Therapy, Class II Extraction Sockets
- What is being tested?
- Stock Abutment Implant and Customized CAD CAM Titanium Milled Abutment Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2024to 20 Dec 2024
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Adults (20 -50)
- Patients will be included if they have one or more of hopeless teeth without signs of acute infection in the maxillary anterior region.
- Remaining roots or non-restorable teeth with sufficient bone apically and palatably to allow proper implant positioning with sufficient primary stability.
- Optimal compliance as evidenced by no missed treatment appointments and a positive attitude towards oral hygiene.
- Medically-free
Who cannot join
- Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
- Smokers, diabetics, pregnant or lactating women.
- 4. History of chemotherapy, radiotherapy in head and/or neck region. 5. Bisphosphonate therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Immediate implant placement in esthetic zones, particularly Class II and III extraction sockets, presents challenges related to soft and hard tissue changes post-extraction. Customized abutments may offer advantages over stock abutments in managing these changes and improving clinical outcomes.
Objective: This study aims to evaluate the comparative effectiveness of customized cad cam titanium milled abutments versus stock abutments on dental implants in Class II extraction sockets in terms of soft and hard tissue integration and aesthetic outcomes.
Methods: A randomized controlled clinical and radiographic trial will be conducted at the Oral Medicine, Periodontology, Oral Diagnosis, and Radiology Department of Tanta University. Forty-eight patients requiring immediate implants in the maxillary anterior region will be randomly assigned to receive either a stock abutment or a customized titanium milled abutment. All implants will be placed using a computer-assisted surgical guide and treated with a collagen plug. Clinical and radiographic evaluations will be performed at baseline, 6 months, and 12 months, utilizing intraoral scanning and cone beam computed tomography (CBCT) to assess peri-implant mucosal levels and crestal bone thickness.
Read the detailed description
Teeth loss is the worst scenario for patients as it is associated with functional, cosmetic and psychological morbidity. The most common cause of tooth loss is Periodontitis but it can also occur due to many causes as dental trauma, dental caries, developmental defects and genetic disorders.
Teeth loss not only impairs quality of life but also indirectly affects the wellbeing of the individual. The missing teeth affects the day-to-day activities of individuals like chewing, speech which results in low self-esteem, loss of confidence, less social interactions and thus hampers the work and daily activities. It may be classified as a handicapping situation Restoring missed or unrestorable teeth using dental implants in esthetic zone is a very challenging aspect of dentistry especially when aiming to restore missed teeth in esthetic zone with immediate implant as it requires a great deal of attention to place the implant finally inn a prosthetic driven position (esthetic zone is defined as the area that appears upon smiling including lip, gingiva and teeth).
While using Immediate implants in esthetic zone specially in compromised extraction sockets as classII or classIII sockets the clinicians are faced with both soft and hard tissue changes after teeth extraction , crestal and facial bone loss followed by soft tissue recession or collapse.
Peri-implant tissue health can be manifested in many items as bleeding on probing(BOP), and probing depth(PD) . In contrast to natural teeth with known reported average PD, the PD of osseointegrated successful implants are a matter of debate. Increased PD may be a sign of inflammation of peri-implant tissues. The extent to which probe penetrates is influenced by many factors such as probing force , probe diameter, roughness of the implant, inflammatory state of the periodontium, and firmness tissues around the dental implants. studies reported that successful implants allows probe penetration to approximately 3-4mm.
Many studies reported crestal bone loss after immediate implant placement as in Markus Huzeler et al who studied peri implant bone level around implants with platform switch abutments, results said that the mean values of crestal bone height at baseline were -0.09 mm +/- 0.65 mm for the platform-switched implants and -1.73 mm +/- 0.46 mm for the non -platform-switched implants.
Also in a study may by U-Covani et al that studied crestal bone changes Around implants placed into fresh extracted sockets showed that The total mean distance from implant shoulder to bone crest at 6 moths was -1.6 ± 0.32 mm.
Soft tissue changes, which are the headache after immediate implants, most of studies reported soft tissue changes after implantation in the term of mid facial gingival height and/or distal and mesial papilla. Many clinical studies revealed that approximately 20% of immediate implants suffered from mucosal recession of at least 1 mm.
In the other hand some studies reported that the type , design and shape of the abutment play an important role in both soft tissue and bone contouring .so in this study we are going to compare the use of stock abutment versus customized cad cam titanium milled abutment over dental implant to monitor the changes in both sof and hard tissue changes.
- Conditions
- Implant Therapy, Class II Extraction Sockets
- Being tested
- Stock Abutment Implant, Customized CAD CAM Titanium Milled Abutment Implant
- Keywords
- Stock abutments, Customized abutments, CAD/CAM technology, Class II extraction sockets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stock Abutment ImplantDevice
Participants in this intervention group receive a two-piece dental implant that utilizes a stock abutment. The stock abutment is a prefabricated component that connects the implant to the prosthetic suprastructure. This intervention aims to evaluate the standard outcomes of using stock abutments in the restoration of teeth in esthetic zones after immediate implant placement.
Customized CAD CAM Titanium Milled Abutment ImplantDevice
Participants in this intervention group are treated with a two-piece dental implant that includes a customized CAD CAM titanium milled abutment. These abutments are tailor-made using computer-aided design and manufacturing to fit the specific contours and needs of the patient's dental structure. This customized approach is hypothesized to offer superior integration with the soft and hard tissues, leading to better aesthetic outcomes and tissue health around the implant area.
| Study group | Role | What they receive |
|---|---|---|
| Stock Abutment Group | Active comparator | This group consists of 24 participants who will receive two-piece dental implants with stock abutments. This arm serves as a control group to assess the standard outcomes associated with conventional abutments used in immediate implant scenarios in the esthetic zone. Receives: Device: Stock Abutment Implant |
| Customized Titanium Milled Abutment Group | Experimental | This group also includes 24 participants and is considered the experimental group. These participants will receive two-piece dental implants equipped with customized cad cam titanium milled abutments. This arm is designed to evaluate the benefits of using customized abutments in terms of better soft and hard tissue integration and aesthetic outcomes compared to the standard stock abutment. Receives: Device: Customized CAD CAM Titanium Milled Abutment Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal Bone Thickness
This outcome assesses the thickness of the crestal bone around the implant. It is critical for maintaining implant stability and aesthetics, with changes potentially indicating either success in osseointegration or issues such as bone resorption.
Measured: Assessments were made at three points, baseline, after six months and twelve months post-implantation.
Peri-implant Mucosal Level Changes
This outcome measures the changes in the peri-implant mucosal levels around the implant site, particularly looking for recession or improvement in the gum tissue adjacent to the implant.
Measured: Assessments were made at three points, baseline, after six months and twelve months post-implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start22 Jan 2024
- Primary completion20 Sep 2024
- Study completion20 Dec 2024
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 Implant TherapyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma ElSayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791655
- Sponsor's protocol ID
- OMPDR042113
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Robaian A, Hamed MM, Ahmed Y, Hassanein FEA. Comparative Evaluation of Customized CAD/CAM vs. Stock Titanium Abutments for Immediate Implant Placement in Class II Extraction Sockets: A Randomized Controlled Trial. Dent J (Basel). 2025 Aug 15;13(8):371. doi: 10.3390/dj13080371.
PubMed 40863074
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized CAD/CAM Titanium-Milled Abutments Vs. Custom Abutments Over Immediate Implants in Class II Extraction Sockets in the Esthetic Zone: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06791655
- Acronym / sponsor ID
- OMPDR042113
- Conditions
- Implant Therapy, Class II Extraction Sockets
- Keywords
- Stock abutments, Customized abutments, CAD/CAM technology, Class II extraction sockets
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 24 Jan 2025 (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.
Background: Immediate implant placement in esthetic zones, particularly Class II and III extraction sockets, presents challenges related to soft and hard tissue changes post-extraction. Customized abutments may offer advantages over stock abutments in managing these changes and improving clinical outcomes.
Objective: This study aims to evaluate the comparative effectiveness of customized cad cam titanium milled abutments versus stock abutments on dental implants in Class II extraction sockets in terms of soft and hard tissue integration and aesthetic outcomes.
Methods: A randomized controlled clinical and radiographic trial will be conducted at the Oral Medicine, Periodontology, Oral Diagnosis, and Radiology Department of Tanta University. Forty-eight patients requiring immediate implants in the maxillary anterior region will be randomly assigned to receive either a stock abutment or a customized titanium milled abutment. All implants will be placed using a computer-assisted surgical guide and treated with a collagen plug. Clinical and radiographic evaluations will be performed at baseline, 6 months, and 12 months, utilizing intraoral scanning and cone beam computed tomography (CBCT) to assess peri-implant mucosal levels and crestal bone thickness.
Detailed description
Teeth loss is the worst scenario for patients as it is associated with functional, cosmetic and psychological morbidity. The most common cause of tooth loss is Periodontitis but it can also occur due to many causes as dental trauma, dental caries, developmental defects and genetic disorders.
Teeth loss not only impairs quality of life but also indirectly affects the wellbeing of the individual. The missing teeth affects the day-to-day activities of individuals like chewing, speech which results in low self-esteem, loss of confidence, less social interactions and thus hampers the work and daily activities. It may be classified as a handicapping situation Restoring missed or unrestorable teeth using dental implants in esthetic zone is a very challenging aspect of dentistry especially when aiming to restore missed teeth in esthetic zone with immediate implant as it requires a great deal of attention to place the implant finally inn a prosthetic driven position (esthetic zone is defined as the area that appears upon smiling including lip, gingiva and teeth).
While using Immediate implants in esthetic zone specially in compromised extraction sockets as classII or classIII sockets the clinicians are faced with both soft and hard tissue changes after teeth extraction , crestal and facial bone loss followed by soft tissue recession or collapse.
Peri-implant tissue health can be manifested in many items as bleeding on probing(BOP), and probing depth(PD) . In contrast to natural teeth with known reported average PD, the PD of osseointegrated successful implants are a matter of debate. Increased PD may be a sign of inflammation of peri-implant tissues. The extent to which probe penetrates is influenced by many factors such as probing force , probe diameter, roughness of the implant, inflammatory state of the periodontium, and firmness tissues around the dental implants. studies reported that successful implants allows probe penetration to approximately 3-4mm.
Many studies reported crestal bone loss after immediate implant placement as in Markus Huzeler et al who studied peri implant bone level around implants with platform switch abutments, results said that the mean values of crestal bone height at baseline were -0.09 mm +/- 0.65 mm for the platform-switched implants and -1.73 mm +/- 0.46 mm for the non -platform-switched implants.
Also in a study may by U-Covani et al that studied crestal bone changes Around implants placed into fresh extracted sockets showed that The total mean distance from implant shoulder to bone crest at 6 moths was -1.6 ± 0.32 mm.
Soft tissue changes, which are the headache after immediate implants, most of studies reported soft tissue changes after implantation in the term of mid facial gingival height and/or distal and mesial papilla. Many clinical studies revealed that approximately 20% of immediate implants suffered from mucosal recession of at least 1 mm.
In the other hand some studies reported that the type , design and shape of the abutment play an important role in both soft tissue and bone contouring .so in this study we are going to compare the use of stock abutment versus customized cad cam titanium milled abutment over dental implant to monitor the changes in both sof and hard tissue changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stock Abutment Group | Active comparator | Device: Stock Abutment ImplantThis group consists of 24 participants who will receive two-piece dental implants with stock abutments. This arm serves as a control group to assess the standard outcomes associated with conventional abutments used in immediate implant scenarios in the esthetic zone. |
| Customized Titanium Milled Abutment Group | Experimental | Device: Customized CAD CAM Titanium Milled Abutment ImplantThis group also includes 24 participants and is considered the experimental group. These participants will receive two-piece dental implants equipped with customized cad cam titanium milled abutments. This arm is designed to evaluate the benefits of using customized abutments in terms of better soft and hard tissue integration and aesthetic outcomes compared to the standard stock abutment. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults (20 -50)
- Patients will be included if they have one or more of hopeless teeth without signs of acute infection in the maxillary anterior region.
- Remaining roots or non-restorable teeth with sufficient bone apically and palatably to allow proper implant positioning with sufficient primary stability.
- Optimal compliance as evidenced by no missed treatment appointments and a positive attitude towards oral hygiene.
- Medically-free
Key exclusion criteria (3 listed)
- Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
- Smokers, diabetics, pregnant or lactating women.
- 4. History of chemotherapy, radiotherapy in head and/or neck region. 5. Bisphosphonate therapy.
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 |
|---|---|---|
| Stock Abutment ImplantParticipants in this intervention group receive a two-piece dental implant that utilizes a stock abutment. The stock abutment is a prefabricated component that connects the implant to the prosthetic suprastructure. This intervention aims to evaluate the standard outcomes of using stock abutments in the restoration of teeth in esthetic zones after immediate implant placement. | Device | Stock Abutment Group |
| Customized CAD CAM Titanium Milled Abutment ImplantParticipants in this intervention group are treated with a two-piece dental implant that includes a customized CAD CAM titanium milled abutment. These abutments are tailor-made using computer-aided design and manufacturing to fit the specific contours and needs of the patient's dental structure. This customized approach is hypothesized to offer superior integration with the soft and hard tissues, leading to better aesthetic outcomes and tissue health around the implant area. | Device | Customized Titanium Milled Abutment Group |
Primary outcome
Crestal Bone Thickness
Time frame: Assessments were made at three points, baseline, after six months and twelve months post-implantation.
This outcome assesses the thickness of the crestal bone around the implant. It is critical for maintaining implant stability and aesthetics, with changes potentially indicating either success in osseointegration or issues such as bone resorption.
Peri-implant Mucosal Level Changes
Time frame: Assessments were made at three points, baseline, after six months and twelve months post-implantation.
This outcome measures the changes in the peri-implant mucosal levels around the implant site, particularly looking for recession or improvement in the gum tissue adjacent to the implant.
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 24 Jan 2025.
- Derived from this study: PubMed 40863074Robaian A, Hamed MM, Ahmed Y, Hassanein FEA. Comparative Evaluation of Customized CAD/CAM vs. Stock Titanium Abutments for Immediate Implant Placement in Class II Extraction Sockets: A Randomized Controlled Trial. Dent J (Basel). 2025 Aug 15;13(8):371. doi: 10.3390/dj13080371.
- Individual participant dataSharing planned: Undecided
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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 Phase 2 study testing Stock Abutment Implant and Customized CAD CAM Titanium Milled Abutment Implant in people with Implant Therapy and Class II Extraction Sockets, run by Ain Shams 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 5 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 24 Jan 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Crestal Bone Thickness (time frame: Assessments were made at three points, baseline, after six months and twelve months post-implantation.). 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 NCT06791655, 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 24 Jan 2025.