Dental ImplantNCT06177275
The Influence of Vertical Implant Position on the Marginal Bone Loss in Thick Versus Thin Phenotype.
A study testing Placement of BLX implants 2 mm sub-crestal i and Placement of BLX implants equicrestal in people with Dental Implant and Vertical Position, run by Cairo University at 1 site in Egypt.
Trial summary
Multiple clinical studies have established high survival rates and tremendous predictability of dental implant treatment (Schiegnitz and Al-Nawas 2018). However, a pleasant esthetic outcome is the patient's primary expectation regarding implants in the esthetic zone (Vermylen et al. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Vertical Position, Esthetic Zone
- What is being tested?
- Placement of BLX implants 2 mm sub-crestal i and Placement of BLX implants equicrestal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Feb 2025
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with single missing upper anterior or premolar teeth
- Patients with minimum buccolingual width of 6 mm and mesiodistal width of 6mm
- Patients with healthy systemic conditions.
- Patients older than 18 years.
- Good oral hygiene.
- Accepts one year follow-up period (cooperative patients).
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- The patient provides informed consent.
- Adequate Inter-arch space for implant placement.
- Favorable occlusion (no traumatic occlusion).
- Absence of allergy to the prescribed medications.
Who cannot join
- Patients with inadequate bone volume and/ or quality
- Patients with local root remnants
- Patients with inadequate wound healing
- Patients with signs of acute infection related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
- Heavy smokers patients (more than 10 cigarettes per day) (Lambert, Morris and Ochi, 2000).
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- Metabolic diseases such as diabetes or hyperthyroidism as well as systemic medications such as chemotherapy or bisphosphonates
- Pregnant or nursing women.
- Uncooperative patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Giza, 00000
nesma m Shemais, PhD, 01005615697, nesma.shemais@gmail.com
About this study
Official title: The Influence of Vertical Implant Position With Immediate Provisionalization on the Marginal Bone Loss in Thick Versus Thin Phenotype. A Randomized Controlled Clinical Trial.
Multiple clinical studies have established high survival rates and tremendous predictability of dental implant treatment (Schiegnitz and Al-Nawas 2018). However, a pleasant esthetic outcome is the patient's primary expectation regarding implants in the esthetic zone (Vermylen et al. 2003)and several esthetic factors have been evaluated to contribute to an esthetic appearance. Among these, the midfacial soft tissue level is considered to be one of the most important factors; Cosyn and co-workers reported that among factors including soft tissue phenotype, the midfacial recession was associated with the position of the implant (Cosyn et al. 2012).
Therefore, subcrestal implant placement has been advocated as it has been associated with the reduction of crestal bone loss in cases with decreased soft tissue thickness. If the vertical soft tissues on the crest of the alveolar ridge are 2 mm or less at the time of implant placement, implants will undergo unavoidable bone resorption by establishing sufficient biologic protection. Another option was proposed by Linkevicius et al, who introduced the subcrestal implant placement as a method to accommodate the problem of thin soft tissues.(Linkevicius et al. 2020).
Read more
Limiting the extent of peri-implant bone loss has been recognized for decades to be an important aspect of long-term implant success, and stable peri-implant bone conditions play an important role in maintaining esthetics (Laurell and Lundgren, 2011).
The opinion expressed widely in the scientific literature has been that subcrestal implant placement leads to increased crestal bone resorption. However, clinical studies addressing the implant placement depth in relation to crestal bone have been rare. Data on subcrestal versus crestal placement have mostly come from animal studies. Even fewer data are available regarding the effects of crestal versus subcrestal positioning of platform-switched implants (Cochran et al., 2009).
This study aims to compare the effect of different vertical implant position with immediate provisionalization on marginal bone loss thin and thick vertical tissue biotype.
- Being tested
- Placement of BLX implants 2 mm sub-crestal i, Placement of BLX implants equicrestal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of BLX implants 2 mm sub-crestal iProcedure or surgery
Placement of BLX implants 2 mm sub-crestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment.
Placement of BLX implants equicrestalProcedure or surgery
Placement of BLX implants equicrestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment.
| Study group | Role | What they receive |
|---|---|---|
| Thin vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal | Experimental | In Thin vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment. Receives: Procedure: Placement of BLX implants 2 mm sub-crestal i |
| Thin vertical soft tissue biotype, Placement of BLX implants equicrestal | Active comparator | In Thin vertical soft tissue biotype, Placement of BLX implants equicrestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment. Receives: Procedure: Placement of BLX implants equicrestal |
| Thick vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal | Experimental | In Thick vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment. Receives: Procedure: Placement of BLX implants 2 mm sub-crestal i |
| Thick vertical soft tissue biotype, Placement of BLX implants equicrestal | Active comparator | In Thick vertical soft tissue biotype, Placement of BLX implants equicrestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment. Receives: Procedure: Placement of BLX implants equicrestal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone loss
Interproximal bone loss will be measured using paralleling cone technique with standardized peri-apical x-ray and bone loss will be measured mesial and distal to the implant by measuring the vertical bone loss from the initial implant position at T3 immediately after implant position and T4 (6 months) and T5 (12 months), ,where interproximal bone loss will be defined as the distance from implant shoulder to the mesial and distal first visible bone-implant contact (fBIC) and (b) bone over the implant platform. One independent and calibrated examiner (A.P.) measured these radiological variables to the nearest 0.1 mm (Pico et al., 2019).
Measured: 1 year
Secondary outcomes (6)
Radiographic horizontal bucco-palatal bone changes
The bucco-palatal width of the alveolar bone will be measured perpendicular to the long axis of the alveolar bone; the 3 measurements will be the at 3 levels implant platform, 2mm and 4 mm . Each measurement will be recorded at different times (at day 0 after finishing the procedure and 12 months post-operatively) (Park et al. 2022).
Measured: 1 year
Radiographic vertical bone changes
Vertical bone height will be measured. Measurement will be taken at highest point of the remaining labial/buccal plate of bone using the implant neck as a reference point. Each measurement will be recorded at different times (at day 0 after finishing the procedure and 12 months post-operatively) and the difference between pre and post-operative measurements will be determined as the gain in labial/buccal vertical bone dimension (Wu et al. 2019
Measured: 1 year
Midfacial recession (MFR):
Corono-apical distance between the peri-implant soft tissue margin and the cemento-enamel junction (CEJ) of the homologous contralateral tooth. Midfacial recession will be (Zucchelli et al. 2019).
Measured: easured at 6, and 12 months
Esthetic evaluation
(The pink esthetic score) 1-14 score
Measured: 1 year
implant survival
A binary outcome, the definition of implant success was based on the clinical and radiographic criteria described by Buser et al. 1990 ;1) absence of clinically detectable implant mobility; 2) absence of pain or any subjective sensation; 3) absence of recurrent peri-implant infection; and 4) absence of persistent radiolucency around the implant after 12 months of loading (Buser, Weber and Lang, 1990)
Measured: 1 year
Emergence Angle
The angle between the tangent line of the restoration at the most coronal point of the buccal mucosa and the implant long axis (Wang et al., 2022).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Dec 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Mohamed Fouad Shemais, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177275
- Sponsor's protocol ID
- NHR
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Vertical Implant Position With Immediate Provisionalization on the Marginal Bone Loss in Thick Versus Thin Phenotype. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06177275
- Acronym / sponsor ID
- NHR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 20 Dec 2023 (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.
Multiple clinical studies have established high survival rates and tremendous predictability of dental implant treatment (Schiegnitz and Al-Nawas 2018). However, a pleasant esthetic outcome is the patient's primary expectation regarding implants in the esthetic zone (Vermylen et al. 2003)and several esthetic factors have been evaluated to contribute to an esthetic appearance. Among these, the midfacial soft tissue level is considered to be one of the most important factors; Cosyn and co-workers reported that among factors including soft tissue phenotype, the midfacial recession was associated with the position of the implant (Cosyn et al. 2012).
Therefore, subcrestal implant placement has been advocated as it has been associated with the reduction of crestal bone loss in cases with decreased soft tissue thickness. If the vertical soft tissues on the crest of the alveolar ridge are 2 mm or less at the time of implant placement, implants will undergo unavoidable bone resorption by establishing sufficient biologic protection. Another option was proposed by Linkevicius et al, who introduced the subcrestal implant placement as a method to accommodate the problem of thin soft tissues.(Linkevicius et al. 2020).
Limiting the extent of peri-implant bone loss has been recognized for decades to be an important aspect of long-term implant success, and stable peri-implant bone conditions play an important role in maintaining esthetics (Laurell and Lundgren, 2011).
The opinion expressed widely in the scientific literature has been that subcrestal implant placement leads to increased crestal bone resorption. However, clinical studies addressing the implant placement depth in relation to crestal bone have been rare. Data on subcrestal versus crestal placement have mostly come from animal studies. Even fewer data are available regarding the effects of crestal versus subcrestal positioning of platform-switched implants (Cochran et al., 2009).
This study aims to compare the effect of different vertical implant position with immediate provisionalization on marginal bone loss thin and thick vertical tissue biotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Thin vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal | Experimental | Procedure: Placement of BLX implants 2 mm sub-crestal iIn Thin vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment. |
| Thin vertical soft tissue biotype, Placement of BLX implants equicrestal | Active comparator | Procedure: Placement of BLX implants equicrestalIn Thin vertical soft tissue biotype, Placement of BLX implants equicrestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment. |
| Thick vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal | Experimental | Procedure: Placement of BLX implants 2 mm sub-crestal iIn Thick vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment. |
| Thick vertical soft tissue biotype, Placement of BLX implants equicrestal | Active comparator | Procedure: Placement of BLX implants equicrestalIn Thick vertical soft tissue biotype, Placement of BLX implants equicrestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with single missing upper anterior or premolar teeth
- Patients with minimum buccolingual width of 6 mm and mesiodistal width of 6mm
- Patients with healthy systemic conditions.
- Patients older than 18 years.
- Good oral hygiene.
Key exclusion criteria (9 listed)
- Patients with inadequate bone volume and/ or quality
- Patients with local root remnants
- Patients with inadequate wound healing
- Patients with signs of acute infection related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
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 |
|---|---|---|
| Placement of BLX implants 2 mm sub-crestal iPlacement of BLX implants 2 mm sub-crestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment. | Procedure or surgery | Thick vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal, Thin vertical soft tissue biotype, Placement of BLX implants 2 mm sub-crestal |
| Placement of BLX implants equicrestalPlacement of BLX implants equicrestal in single missing anterior or premolar teeth in the esthetic zone with immediate provisionalization via a straight emergence profile temporary crown on a temporary abutment. | Procedure or surgery | Thick vertical soft tissue biotype, Placement of BLX implants equicrestal, Thin vertical soft tissue biotype, Placement of BLX implants equicrestal |
Primary outcome
Crestal bone loss
Time frame: 1 year
Interproximal bone loss will be measured using paralleling cone technique with standardized peri-apical x-ray and bone loss will be measured mesial and distal to the implant by measuring the vertical bone loss from the initial implant position at T3 immediately after implant position and T4 (6 months) and T5 (12 months), ,where interproximal bone loss will be defined as the distance from implant shoulder to the mesial and distal first visible bone-implant contact (fBIC) and (b) bone over the implant platform. One independent and calibrated examiner (A.P.) measured these radiological variables to the nearest 0.1 mm (Pico et al., 2019).
6 secondary outcomes
Radiographic horizontal bucco-palatal bone changes
Time frame: 1 year
Radiographic vertical bone changes
Time frame: 1 year
Midfacial recession (MFR):
Time frame: easured at 6, and 12 months
Esthetic evaluation
Time frame: 1 year
implant survival
Time frame: 1 year
Emergence Angle
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of BLX implants 2 mm sub-crestal i and Placement of BLX implants equicrestal in people with Dental Implant and Vertical Position, 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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crestal bone loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2023.