Dental Implant FailedNCT05973357
The Influence of Vertical Implant Position With Immediate Provisionalization on the Marginal Bone Loss.
A study testing Sub-crestal implant and Equi-crestal implant in people with Dental Implant Failed and Implant Site Reaction, run by Cairo University.
Trial summary
Multiple clinical studies have established high survival rates and tremendous predictability of dental implant treatment. However, a pleasant esthetic outcome is the patient's primary expectation regarding implants in the esthetic zone and several esthetic factors have been evaluated to contribute to an esthetic… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed, Implant Site Reaction
- What is being tested?
- Sub-crestal implant and Equi-crestal implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2023to 30 Oct 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- 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.
About this study
Official title: The Influence of Vertical Implant Position With Immediate Provisionalization on the Marginal Bone Loss: A Randomized Controlled Clinical Trial
Multiple clinical studies have established high survival rates and tremendous predictability of dental implant treatment. However, a pleasant esthetic outcome is the patient's primary expectation regarding implants in the esthetic zone 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 .
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.
Read more
Research question:
Does the placement of delayed implants with different vertical depth affect the marginal bone loss with immediate provisionalization?
Read the detailed description
Preservation of crestal bone is crucial and must be prioritized from the onset of implant placement. Adequate amount of peri-implant bone contributes to esthetic success and implant stability. Crestal bone contributes to both esthetics and function. Resorption of crestal bone is seen as loss of interproximal papillary support and gingival recession, which gives way to peri-implantitis and compromises esthetics.
With respect to the depth of insertion, implants can be placed at various levels in the bone, in which affects the peri-implant tissues with the surrounding marginal bone. Therefore, Placement of an implant in a deeper position with re¬spect to the bone crest (subcrestal placement) has been suggested as a method that could contribute to main¬tain the periimplant soft and hard tissues in comparison with crestal placement, though this affirmation is sub¬ject to controversy.
Rationale for conducting the research:
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.
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.
In a prospective research, Nagarajan et al. implanted equicrestal and subcrestal implants to examine the crestal bone levels prior to loading. The crestal bone levels of the implants placed equicrestally (1.31 mm 1.04 mm and 0.68 mm 1.08 mm on mesial and distal surfaces, respectively) were higher than those of implants placed subcrestally (0.49 mm 0.49 mm and 0.025 mm 6.06 mm on mesial and distal surfaces, respectively), with a P value of crestal bone level for both groups being 0.12 and 0. They came to the conclusion that there was no difference in the amount of crestal bone loss prior to prosthetic loading between implants placed at subcrestal and equicrestal levels. In this study eqi-crestal implant will be used as a comparator but with immediate loading.
- Conditions
- Dental Implant Failed, Implant Site Reaction
- Being tested
- Sub-crestal implant, Equi-crestal implant
- Keywords
- Delayed Implant, Immediate loading, Temporization, provisionalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-crestal implantProcedure or surgery
Patients receiving delayed implant placed 2mm sub-crestal level with immediate provisionalization
Equi-crestal implantProcedure or surgery
Patients receiving delayed implant placed equi-crestal level with immediate provisionalization
| Study group | Role | What they receive |
|---|---|---|
| Sub-crestal group | Experimental | Patients receiving delayed implant placed 2mm sub-crestal level with immediate provisionalization Receives: Procedure: Sub-crestal implant |
| Equi-crestal grouo | Experimental | Patients receiving delayed implant placed equi-crestal level with immediate provisionalization Receives: Procedure: Equi-crestal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
Crestal bone loss
Measured: 1 year follow up
Secondary outcomes (5)
Mid facial recession
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 measured at 6, and 12 months.
Measured: 1 year follow up
The pink esthetic score
The pink esthetic score will be calculated on the parameters defined by. Clinical photographs will be taken to evaluate peri-implant soft tissue through evaluating seven variables compared to a natural reference tooth including: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14.
Measured: 1 year follow up
Gingival Thickness
Gingival thickness will be measured using an anesthetic needle with a rubber stopper, trans-gingivally piercing tissues horizontally perpendicular to the long axis of the tooth/implant until it contacts bone, at 3 different points; three readings mid-buccally at three different levels; 2mm, 4mm and 6mm apical to the gingival margin. The length of the part of the instrument that penetrates into the soft tissue is measured in mm using a digital caliper (Wiesner et al., 2010).
Measured: 1 year follow up
Implant Survival
A binary outcome, the definition of implant success was based on the clinical and radiographic criteria;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
Measured: 1 year follow up
Post-operative patient satisfaction
A 12-items questionnaire are self-reported by the patients after 12 months post-operative; 6 questions with with visual analoge scale from 1 to 10 with poorest score is not very satisfied equal 0 and optimum score is satisfied which equals 10. The another 6 questions is yes or no questions
This questions measure patient's acceptability and esthetics satisfaction
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start20 Sep 2023 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies 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, RWGWanis, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973357
- Sponsor's protocol ID
- 1407
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2023
- Last updated
- 2 Aug 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 2 Aug 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: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05973357
- Acronym / sponsor ID
- 1407
- Conditions
- Dental Implant Failed, Implant Site Reaction
- Keywords
- Delayed Implant, Immediate loading, Temporization, provisionalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 2 Aug 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. However, a pleasant esthetic outcome is the patient's primary expectation regarding implants in the esthetic zone 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 .
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.
Research question:
Does the placement of delayed implants with different vertical depth affect the marginal bone loss with immediate provisionalization?
Detailed description
Preservation of crestal bone is crucial and must be prioritized from the onset of implant placement. Adequate amount of peri-implant bone contributes to esthetic success and implant stability. Crestal bone contributes to both esthetics and function. Resorption of crestal bone is seen as loss of interproximal papillary support and gingival recession, which gives way to peri-implantitis and compromises esthetics.
With respect to the depth of insertion, implants can be placed at various levels in the bone, in which affects the peri-implant tissues with the surrounding marginal bone. Therefore, Placement of an implant in a deeper position with re¬spect to the bone crest (subcrestal placement) has been suggested as a method that could contribute to main¬tain the periimplant soft and hard tissues in comparison with crestal placement, though this affirmation is sub¬ject to controversy.
Rationale for conducting the research:
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.
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.
In a prospective research, Nagarajan et al. implanted equicrestal and subcrestal implants to examine the crestal bone levels prior to loading. The crestal bone levels of the implants placed equicrestally (1.31 mm 1.04 mm and 0.68 mm 1.08 mm on mesial and distal surfaces, respectively) were higher than those of implants placed subcrestally (0.49 mm 0.49 mm and 0.025 mm 6.06 mm on mesial and distal surfaces, respectively), with a P value of crestal bone level for both groups being 0.12 and 0. They came to the conclusion that there was no difference in the amount of crestal bone loss prior to prosthetic loading between implants placed at subcrestal and equicrestal levels. In this study eqi-crestal implant will be used as a comparator but with immediate loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub-crestal group | Experimental | Procedure: Sub-crestal implantPatients receiving delayed implant placed 2mm sub-crestal level with immediate provisionalization |
| Equi-crestal grouo | Experimental | Procedure: Equi-crestal implantPatients receiving delayed implant placed equi-crestal level with immediate provisionalization |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- ● Patients with single missing upper anterior or premolar teeth
Key exclusion criteria (9 listed)
- ● Patients with inadequate bone volume and/ or quality
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 |
|---|---|---|
| Sub-crestal implantPatients receiving delayed implant placed 2mm sub-crestal level with immediate provisionalization | Procedure or surgery | Sub-crestal group |
| Equi-crestal implantPatients receiving delayed implant placed equi-crestal level with immediate provisionalization | Procedure or surgery | Equi-crestal grouo |
Primary outcome
Marginal bone loss
Time frame: 1 year follow up
Crestal bone loss
5 secondary outcomes
Mid facial recession
Time frame: 1 year follow up
The pink esthetic score
Time frame: 1 year follow up
Gingival Thickness
Time frame: 1 year follow up
Implant Survival
Time frame: 1 year follow up
Post-operative patient satisfaction
Time frame: 1 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sub-crestal implant and Equi-crestal implant in people with Dental Implant Failed and Implant Site Reaction, run by Cairo University.
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 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Marginal bone loss (time frame: 1 year follow up). 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 2 Aug 2023.