Crestal Bone LossPhase 2PSNCT02761226
Clinical and Radiographic Evaluation of Crestal Bone Loss Around Implant With or Without Platform Switching Design
A Phase 2 study testing Platform Matched Design (Group A) and Platform Switching Design (Group B) in people with Crestal Bone Loss, run by Cairo University.
Trial summary
Implants have become the preferred method of single tooth replacement these days, patients receiving implant treatments not only expect restoration of masticatory function, they also expect that the prostheses will be esthetically pleasing, easy to clean, and permanent. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Crestal Bone Loss
- What is being tested?
- Platform Matched Design (Group A) and Platform Switching Design (Group B)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to May 2016
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients older than18 yrs.
- Patients with missing teeth in the posterior maxilla (from the 1st premolar to 2nd Molar) bilaterally in need for fixed implant-supported prosthesis.
- Full mouth plaque score and full mouth bleeding score ˂25 %
- Patients with adequate bone quality and quantity at the implant site
- Patients with systematic healthy.
- Non-smokers or those smoking ˂10 cigarettes/day
- Patients who were cooperative, motivated, and hygiene conscious and willing to return for multiple follow-up appointments (up to 9 months after prosthetic loading).
Who cannot join
- General:-
- Patients with any systemic condition that may contraindicate implant therapy.
- Patients with a history of Bisphosphonate therapy
- Pregnant and lactating patients
- Alcohol and drug abuse
- Parafunctional habits that produce overload on the implant such as bruxism and clenching.
Show all 14Show fewer
- Local:-
- Local inflammation or infection at implant site.
- Untreated periodontitis
- Local irradiation therapy
- History of implant failure as well as unhealed extraction socket
- Inadequate keratinized gingiva or thin gingival biotype.
- Inadequate bone height or width.
- Insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
About this study
Official title: Clinical and Radiographic Evaluation of Crestal Bone Loss Around Implant With or Without Platform Switching Design (Randomized Clinical Trial, Split Mouth Design)
Implants have become the preferred method of single tooth replacement these days, patients receiving implant treatments not only expect restoration of masticatory function, they also expect that the prostheses will be esthetically pleasing, easy to clean, and permanent. To maintain long-term implant stability, it is important to minimize bone loss around the implant, as well as the soft tissue atrophy that accompanies it.
Read the detailed description
The peri-implant bone level has been used as one of the criteria to assess the success of dental implants, Platform switching (PLS) for maintaining peri-implant bone levels has gained popularity among implant manufacturers over the last few years. However, the assumption that the inward shifting of the implant- abutment junction may preserve crestal bone was primarily based on serendipitous finding rather than scientific evidence.
It is known that saucerization around an implant occurs following abutment connection using a submerged implant with a butt joint (a two-stage approach), such as the Branemark implant. The nature of saucerization varies according to implant type (one-stage or two-stage) and abutment connection type. they have reported that the factors that are the most likely causes of early crestal bone loss around implants are:
- The micro-gap,
- The implant crest module,
- Occlusal overload, and
- The biologic width around the dental implant. At the Toronto Conference 1998, the consensus with respect to bone loss around the implant was that bone loss of up to approximately 2 mm during the first year of implant function is acceptable, and at this level the implant is regarded as successful. There have been many reports on studies to ascertain the causes of bone loss around implants and clinical techniques to prevent it. Some reports published in 2005 and 2006 state that the platform switching technique, a technique in which an abutment that is one-size smaller than the implant platform is placed, prevents bone loss around the implant. However, there are only a few reports on the mechanism of action or the extent of bone loss prevention, and as such, it is difficult to say that the effect of PLS has been thoroughly examined. This review article examines the PLS technique and the bone loss preventive effect.
A lot of clinical studies discussed the concept of platform switching was extensively studied histologically and biomechanically. In histomorphometric studies in dogs was no significant difference in the marginal bone level around platform- switched and -matched implants after 28 days of healing. In contrast, other studies reported a significantly less bone loss around platform-switched implants after a loading period of 2 to 6months.
However, there is no consistency among the studies with respect to the study design (e.g. the location and depth of the implant, and controlled/non-controlled), and as such, it is difficult to evaluate all of these studies using the same evaluation method.
The review and meta-analysis show that platform switching may preserve interimplant bone height and soft tissue levels. The degree of marginal bone resorption is inversely related to the extent of the implant- abutment mismatch. But still no general agreement to confirm the validity of this concept, so Further long-term, well-conducted, randomized controlled studies are needed to confirm the validity of this concept.
- Conditions
- Crestal Bone Loss
- Being tested
- Platform Matched Design (Group A), Platform Switching Design (Group B)
- Keywords
- platform switching, dental implant, crestal bone level, implant stability, postoperative complication
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platform Matched Design (Group A)Procedure or surgery
Also called group 1
10 patients with missing upper posterior teeth will receive dental implant with platform matched design (the patients will receive implant 4.2mm with same abutment diameter 4.2mm)
Platform Switching Design (Group B)Procedure or surgery
Also called group 2
10 patients with missing upper posterior teeth will receive dental implant with platform switching design(the patients will receive implant 4.2mm with smaller abutment diameter 3.5 mm
| Study group | Role | What they receive |
|---|---|---|
| Group A (Platform Matched Design) | Experimental | 10 Patients with missing tooth in upper posterior area will receive dental implant (implants with the same abutment diameter) Receives: Procedure: Platform Matched Design (Group A) |
| Group B (intervention - Platform Switching Design) | Active comparator | 10 patients with missing tooth in upper posterior area will receive dental implant (implants with smaller diameter abutment) Receives: Procedure: Platform Switching Design (Group B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
crestal bone loss
assessment crestal bone loss after 9 months after crown placement
Measured: 9 months
Secondary outcomes (1)
implant stability
assessment implant placement by periotest at abutment instillation and after 9 month of crown placement
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crestal Bone LossStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Serag, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761226
- Sponsor's protocol ID
- 20008
- Acronym
- PS
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2016
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Crestal Bone Loss Around Implant With or Without Platform Switching Design (Randomized Clinical Trial, Split Mouth Design)
- ClinicalTrials.gov ID
- NCT02761226
- Acronym / sponsor ID
- PS / 20008
- Conditions
- Crestal Bone Loss
- Keywords
- platform switching, dental implant, crestal bone level, implant stability, postoperative complication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 May 2016 (estimated)
- 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.
Implants have become the preferred method of single tooth replacement these days, patients receiving implant treatments not only expect restoration of masticatory function, they also expect that the prostheses will be esthetically pleasing, easy to clean, and permanent. To maintain long-term implant stability, it is important to minimize bone loss around the implant, as well as the soft tissue atrophy that accompanies it.
Detailed description
The peri-implant bone level has been used as one of the criteria to assess the success of dental implants, Platform switching (PLS) for maintaining peri-implant bone levels has gained popularity among implant manufacturers over the last few years. However, the assumption that the inward shifting of the implant- abutment junction may preserve crestal bone was primarily based on serendipitous finding rather than scientific evidence.
It is known that saucerization around an implant occurs following abutment connection using a submerged implant with a butt joint (a two-stage approach), such as the Branemark implant. The nature of saucerization varies according to implant type (one-stage or two-stage) and abutment connection type. they have reported that the factors that are the most likely causes of early crestal bone loss around implants are:
- The micro-gap,
- The implant crest module,
- Occlusal overload, and
- The biologic width around the dental implant. At the Toronto Conference 1998, the consensus with respect to bone loss around the implant was that bone loss of up to approximately 2 mm during the first year of implant function is acceptable, and at this level the implant is regarded as successful. There have been many reports on studies to ascertain the causes of bone loss around implants and clinical techniques to prevent it. Some reports published in 2005 and 2006 state that the platform switching technique, a technique in which an abutment that is one-size smaller than the implant platform is placed, prevents bone loss around the implant. However, there are only a few reports on the mechanism of action or the extent of bone loss prevention, and as such, it is difficult to say that the effect of PLS has been thoroughly examined. This review article examines the PLS technique and the bone loss preventive effect.
A lot of clinical studies discussed the concept of platform switching was extensively studied histologically and biomechanically. In histomorphometric studies in dogs was no significant difference in the marginal bone level around platform- switched and -matched implants after 28 days of healing. In contrast, other studies reported a significantly less bone loss around platform-switched implants after a loading period of 2 to 6months.
However, there is no consistency among the studies with respect to the study design (e.g. the location and depth of the implant, and controlled/non-controlled), and as such, it is difficult to evaluate all of these studies using the same evaluation method.
The review and meta-analysis show that platform switching may preserve interimplant bone height and soft tissue levels. The degree of marginal bone resorption is inversely related to the extent of the implant- abutment mismatch. But still no general agreement to confirm the validity of this concept, so Further long-term, well-conducted, randomized controlled studies are needed to confirm the validity of this concept.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Platform Matched Design) | Experimental | Procedure: Platform Matched Design (Group A)10 Patients with missing tooth in upper posterior area will receive dental implant (implants with the same abutment diameter) |
| Group B (intervention - Platform Switching Design) | Active comparator | Procedure: Platform Switching Design (Group B)10 patients with missing tooth in upper posterior area will receive dental implant (implants with smaller diameter abutment) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients older than18 yrs.
- Patients with missing teeth in the posterior maxilla (from the 1st premolar to 2nd Molar) bilaterally in need for fixed implant-supported prosthesis.
- Full mouth plaque score and full mouth bleeding score ˂25 %
- Patients with adequate bone quality and quantity at the implant site
- Patients with systematic healthy.
Key exclusion criteria (14 listed)
- General:-
- Patients with any systemic condition that may contraindicate implant therapy.
- Patients with a history of Bisphosphonate therapy
- Pregnant and lactating patients
- Alcohol and drug abuse
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 |
|---|---|---|
| Platform Matched Design (Group A)Also: group 110 patients with missing upper posterior teeth will receive dental implant with platform matched design (the patients will receive implant 4.2mm with same abutment diameter 4.2mm) | Procedure or surgery | Group A (Platform Matched Design) |
| Platform Switching Design (Group B)Also: group 210 patients with missing upper posterior teeth will receive dental implant with platform switching design(the patients will receive implant 4.2mm with smaller abutment diameter 3.5 mm | Procedure or surgery | Group B (intervention - Platform Switching Design) |
Primary outcome
crestal bone loss
Time frame: 9 months
assessment crestal bone loss after 9 months after crown placement
1 secondary outcome
implant stability
Time frame: 9 months
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 10 May 2016.
- Individual participant dataSharing planned: Undecided
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Clinical and Radiographic Evaluation of CGF and Alloplastic Grafting in Participants Undergoing the Socket Shield Technique for Immediate Anterior Maxillary Implant Placement. This Study Assesses Bone Healing and Stability When Managing the Crestal Gap in the Esthetic Zone.
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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 Phase 2 study testing Platform Matched Design (Group A) and Platform Switching Design (Group B) in people with Crestal Bone Loss, 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 7 inclusion and 14 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 10 May 2016. 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.
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 loss (time frame: 9 months). 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 10 May 2016.