Dental ImplantNCT04731545
Buccal Bone Resorption in Immediate SLActive Implant Placement Thin vs. Thick Buccal Bone
A study testing immediate implant placement in people with Dental Implant and Immediate Implant, run by Cairo University at 1 site in Egypt.
Trial summary
The utilization of SLActive implants which allow more rapid osseointgeration with 3 to 4 weeks. will be placed in thin buccal bone as immediate implants to determine the resorption compared to thick buccal bone Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Immediate Implant
- What is being tested?
- immediate implant placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2017to 1 Jun 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Single bounded irrestorable tooth in the esthetic zone that needs to be extracted.
- Healthy systemic condition.
- Type I socket with a minimum of 1mm of buccal bone thickness prior to extraction. (Morton et al., 2014)
- Sufficient bone apical to the socket for implant primary stability. (Morton et al., 2014)
- Good oral hygiene.
- Patient accepts a minimum of three-year follow-up period (cooperative patients).
Who cannot join
- Signs of acute infection related to the area of interest.
- Patients with parafunctional habits (Lobbezoo et al. 2006 and Roelhing et al. 2016).
- Smokers (Lambert et al. 2000).
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Buccal Bone Resorption in Immediate SLActive Implant Placement in Thin vs. Thick Buccal Bone Plates: RCT
The utilization of SLActive implants which allow more rapid osseointgeration with 3 to 4 weeks. will be placed in thin buccal bone as immediate implants to determine the resorption compared to thick buccal bone
Read the detailed description
With the increased demand for aesthetics and the expectation of immediate tooth replacement, improving the treatment options in case with hopeless teeth in the esthetic zone by immediate implants is a need by both practitioners and patients.
Current guidelines, today, restricting such treatment to only thick (+ or = 1mm) buccal bone plates. However, the literature shows that less than 10% of the community have such criteria, making it a high risk but needed procedure.
Soft tissue and bone remodelling after extraction is an inescapable fact. Immediate implant placement cannot prevent soft tissue and bone remodeling around implants (Araújo et al. 2005, Chen et al. 2009), but implant surface treatment and modifications might enhance the maintainability of the supporting structures around the dental implant due to its faster integration, better stimulating the vascular components at the site. This could be tested by the crestal and buccal bone changes, pink esthetic score and ostell readings.
- Conditions
- Dental Implant, Immediate Implant
- Being tested
- immediate implant placement
- Keywords
- immediate implant, esthetic zone, buccal plate, SLActive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placementDevice
Minimally traumatic tooth extraction, immediate implant placement and hard tissue grafting. loading after 3 months.
| Study group | Role | What they receive |
|---|---|---|
| thin buccal bone | Active comparator | Not described Receives: Device: immediate implant placement |
| thick buccal bone | Active comparator | Not described Receives: Device: immediate implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bucccal bone changes
standardized Cone beam computed Tomography The radiograph will be taken preoperatively and 12 month after. The pre and post operative cone beams will be compared to each other observing any changes of the buccal bone at 2 , 4 and 6 mm from the crest, the measurements will be in mm
Measured: 12 months post loading
Secondary outcomes (7)
Implant stability
Ostell readings in isq (range from 55 till over 70) bleow 55 low stability over 55 till 65 moderate stability above 70 good stability
Measured: 3 months
Crestal bone changes
Periapical radiograph the measurements will be taken from the platform of the implants. 3 readings will be taken one at the paltform one above and one below according to pattern and form of the resorption.
Measured: 12 months post loading
Soft tissue thickness
Periodontal probe
Measured: 3 months
Post operative pain and swelling
Blinded assessment ( numerical score)
Measured: 1 week
Buccal bone thickness
Cone Beam Computed Topography
Measured: 3 months
Postsurgical satisfaction
Questionnaire
Measured: 1 week
Pink aesthetic score
Pink esthetic score Scale 0 being the lowest and 14 highest attainable
Measured: 12 months post loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start15 Jan 2017
- Primary completion1 Jul 2021
- Study completion1 Jun 2022
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Principal investigator, Hani Elnahass, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731545
- Sponsor's protocol ID
- 333
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
ElNahass H, Tawfik OK, Naiem SN, Zazou N, Moussa M. Evaluation of buccal bone resorption in immediate implant placement in thin versus thick buccal bone plates: An 18-month follow-up prospective cohort study. Clin Implant Dent Relat Res. 2024 Jun;26(3):532-544. doi: 10.1111/cid.13312. Epub 2024 Feb 21.
PubMed 38380779
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Buccal Bone Resorption in Immediate SLActive Implant Placement in Thin vs. Thick Buccal Bone Plates: RCT
- ClinicalTrials.gov ID
- NCT04731545
- Acronym / sponsor ID
- 333
- Conditions
- Dental Implant, Immediate Implant
- Keywords
- immediate implant, esthetic zone, buccal plate, SLActive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 1 Feb 2021 (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.
The utilization of SLActive implants which allow more rapid osseointgeration with 3 to 4 weeks. will be placed in thin buccal bone as immediate implants to determine the resorption compared to thick buccal bone
Detailed description
With the increased demand for aesthetics and the expectation of immediate tooth replacement, improving the treatment options in case with hopeless teeth in the esthetic zone by immediate implants is a need by both practitioners and patients.
Current guidelines, today, restricting such treatment to only thick (+ or = 1mm) buccal bone plates. However, the literature shows that less than 10% of the community have such criteria, making it a high risk but needed procedure.
Soft tissue and bone remodelling after extraction is an inescapable fact. Immediate implant placement cannot prevent soft tissue and bone remodeling around implants (Araújo et al. 2005, Chen et al. 2009), but implant surface treatment and modifications might enhance the maintainability of the supporting structures around the dental implant due to its faster integration, better stimulating the vascular components at the site. This could be tested by the crestal and buccal bone changes, pink esthetic score and ostell readings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thin buccal bone | Active comparator | Device: immediate implant placement |
| thick buccal bone | Active comparator | Device: immediate implant placement |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Single bounded irrestorable tooth in the esthetic zone that needs to be extracted.
- Healthy systemic condition.
- Type I socket with a minimum of 1mm of buccal bone thickness prior to extraction. (Morton et al., 2014)
- Sufficient bone apical to the socket for implant primary stability. (Morton et al., 2014)
- Good oral hygiene.
Key exclusion criteria (4 listed)
- Signs of acute infection related to the area of interest.
- Patients with parafunctional habits (Lobbezoo et al. 2006 and Roelhing et al. 2016).
- Smokers (Lambert et al. 2000).
- Pregnant females.
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 placementMinimally traumatic tooth extraction, immediate implant placement and hard tissue grafting. loading after 3 months. | Device | thick buccal bone, thin buccal bone |
Primary outcome
Bucccal bone changes
Time frame: 12 months post loading
standardized Cone beam computed Tomography The radiograph will be taken preoperatively and 12 month after. The pre and post operative cone beams will be compared to each other observing any changes of the buccal bone at 2 , 4 and 6 mm from the crest, the measurements will be in mm
7 secondary outcomes
Implant stability
Time frame: 3 months
Crestal bone changes
Time frame: 12 months post loading
Soft tissue thickness
Time frame: 3 months
Post operative pain and swelling
Time frame: 1 week
Buccal bone thickness
Time frame: 3 months
Postsurgical satisfaction
Time frame: 1 week
Pink aesthetic score
Time frame: 12 months post loading
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 23 Jan 2024.
- Derived from this study: PubMed 38380779ElNahass H, Tawfik OK, Naiem SN, Zazou N, Moussa M. Evaluation of buccal bone resorption in immediate implant placement in thin versus thick buccal bone plates: An 18-month follow-up prospective cohort study. Clin Implant Dent Relat Res. 2024 Jun;26(3):532-544. doi: 10.1111/cid.13312. Epub 2024 Feb 21.
- 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 study testing immediate implant placement in people with Dental Implant and Immediate 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 6 inclusion and 4 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 23 Jan 2024. 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?
Bucccal bone changes (time frame: 12 months post loading). 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 NCT04731545, 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 23 Jan 2024.