Missing ToothNCT03614442
Effect of Slopped Shoulder Implant Neck vs Conventional Implant Neck Design on Crestal Bone Level in the Maxilla
A study testing slopped shoulder implant in people with Missing Tooth, run by Cairo University.
Trial summary
In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Tooth
- What is being tested?
- slopped shoulder implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2018to 1 Sep 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good oral hygiene
- Systemically healthy (free from any systemic diseases).
- Adequate native bone to achieve implant primary stability
- Have had the tooth extraction at least 3 months before implant surgery.
- Did not receive soft or hard tissue augmentation before or in conjunction with implant surgery
Who cannot join
- Smokers
- Pregnant woman
- Had a history of alcoholism or drug abuse within the past 5 years.
- Had bruxism or clenching habits.
- Patients who refused to join the study.
- Had significant untreated periodontal disease or history of treated periodontitis.
Show all 10Show fewer
- Had caries on teeth adjacent to the prospective implant site.
- Periapical infection.
- localized radiation therapy of the oral cavity; antitumor chemotherapy.
- poor oral hygiene
About this study
Official title: Evaluation of the Effect of Slopped Shoulder Implant Neck Versus Conventional Implant Neck Design on the Crestal Bone Level in the Maxilla: Randomized Clinical Trial (RCT)
In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform matching.The aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues.
Read the detailed description
Implant prosthesis allows normal muscle function, and the implant stimulates the bone and maintains its dimensions in a manner similar to healthy natural teeth. Crestal bone loss can result in increased bacterial accumulation resulting in secondary peri-implant inflammation and bone loss which can further result in loss of alveolar support, which in turn can lead to occlusal overload resulting in implant failure. In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform matching. The authors developed the concept of slopped shoulder implant which results in an inward bone creeping at the coronal part of the implant to be in continuity with the alveolar bone crest.
The rational to use this type of implant allows an increase at residual crestal bone volume around the implant neck and has 3 merits:
- Reduced mechanical stress at the implant neck area;
- Repositioning of gingival papillae on the beveled neck implant (that is the physiologic condition);
- proper vascular supply to the implant investing structure and bone tissue also because of reduced inter-implant space.
The aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues
- Conditions
- Missing Tooth
- Being tested
- slopped shoulder implant
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slopped shoulder implantOther
different implant design to enhance soft and hard tissue outcome
| Study group | Role | What they receive |
|---|---|---|
| slopped shoulder implant | Experimental | The osteotomy site will be prepared using appropriate drill sizes with flapless approach, The implant (conventional neck implant design )will be inserted till the platform will be flushed with the crestal bone, The primary stability will be checked using torque wrench Receives: Other: slopped shoulder implant |
| conventional implant with flat platform | Active comparator | inserted implant will be bone leveled implant (crestal maxi z) implant (conventional implant with platform). The primary stability will be checked using torque wrench Receives: Other: slopped shoulder implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
pink esthetic score(PES)
soft tissue esthetics scale : Seven variables will be evaluated vs. a natural reference tooth: 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: 8 months
Secondary outcomes (2)
crestal bone resorption
bone loss around implant neck will be measured using (CBCT) cone beam computed tomography. On CBCT scans, the amount of bone resorption in the buccal, lingual/palatal, mesial and distal surfaces will be determined by measuring the distance from the platform of the implant to the alveolar crest (normal group: 0-1.5mm, mild bone loss: 1.6-3mm, moderate bone loss: 3.1-4.5mm and severe bone loss: >4.5mm)
Measured: 8 months
implant stability
osteointegration of dental implant using (periotest device ).Periotest value range:
- 8.0 to0.0 Good osseointegration
- 0.1 to +9.9 the implant can be loaded
- 10.0 or higher loading of the implant might or might not be possible
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start30 Jul 2018 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing ToothStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Ahmed Sharawi Shehabeldin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614442
- Sponsor's protocol ID
- platform switching 2018
- Status last verified
- Jul 2018
- First submitted
- 16 Jul 2018
- Last updated
- 3 Aug 2018
- 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 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Slopped Shoulder Implant Neck Versus Conventional Implant Neck Design on the Crestal Bone Level in the Maxilla: Randomized Clinical Trial (RCT)
- ClinicalTrials.gov ID
- NCT03614442
- Acronym / sponsor ID
- platform switching 2018
- Conditions
- Missing Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jul 2018 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 3 Aug 2018 (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.
In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform matching.The aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues.
Detailed description
Implant prosthesis allows normal muscle function, and the implant stimulates the bone and maintains its dimensions in a manner similar to healthy natural teeth. Crestal bone loss can result in increased bacterial accumulation resulting in secondary peri-implant inflammation and bone loss which can further result in loss of alveolar support, which in turn can lead to occlusal overload resulting in implant failure. In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform matching. The authors developed the concept of slopped shoulder implant which results in an inward bone creeping at the coronal part of the implant to be in continuity with the alveolar bone crest.
The rational to use this type of implant allows an increase at residual crestal bone volume around the implant neck and has 3 merits:
- Reduced mechanical stress at the implant neck area;
- Repositioning of gingival papillae on the beveled neck implant (that is the physiologic condition);
- proper vascular supply to the implant investing structure and bone tissue also because of reduced inter-implant space.
The aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| slopped shoulder implant | Experimental | Other: slopped shoulder implantThe osteotomy site will be prepared using appropriate drill sizes with flapless approach, The implant (conventional neck implant design )will be inserted till the platform will be flushed with the crestal bone, The primary stability will be checked using torque wrench |
| conventional implant with flat platform | Active comparator | Other: slopped shoulder implantinserted implant will be bone leveled implant (crestal maxi z) implant (conventional implant with platform). The primary stability will be checked using torque wrench |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Good oral hygiene
- Systemically healthy (free from any systemic diseases).
- Adequate native bone to achieve implant primary stability
- Have had the tooth extraction at least 3 months before implant surgery.
- Did not receive soft or hard tissue augmentation before or in conjunction with implant surgery
Key exclusion criteria (10 listed)
- Smokers
- Pregnant woman
- Had a history of alcoholism or drug abuse within the past 5 years.
- Had bruxism or clenching habits.
- Patients who refused to join the study.
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 |
|---|---|---|
| slopped shoulder implantdifferent implant design to enhance soft and hard tissue outcome | Other | conventional implant with flat platform, slopped shoulder implant |
Primary outcome
pink esthetic score(PES)
Time frame: 8 months
soft tissue esthetics scale : Seven variables will be evaluated vs. a natural reference tooth: 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.
2 secondary outcomes
crestal bone resorption
Time frame: 8 months
implant stability
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- 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 slopped shoulder implant in people with Missing Tooth, 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 5 inclusion and 10 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 3 Aug 2018. 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?
pink esthetic score(PES) (time frame: 8 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 3 Aug 2018.