Marginal Bone Loss and Loss of Osteointegration of Short ImplantNCT04972240
Stability, Marginal Bone Loss and Occlusal Load Analysis of PEEK Abutment Supported on Short Implant
A study testing customization of abutment in people with Marginal Bone Loss and Loss of Osteointegration of Short Implant, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
this study will be directed toward evaluating stability, marginal bone loss and occlusal load of posterior customized PEEK abutments on Ti-bases supported by short implant Read more about this study
- Who is it for?
- Ages 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Marginal Bone Loss and Loss of Osteointegration of Short Implant
- What is being tested?
- customization of abutment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2021to Aug 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 30 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Age range of patients 30-45 years old, with no gender prediction, able to read and sign the informed consent. 2. Patient with missing posterior tooth indicated for replacement with short implant as there are any anatomical limitation (near maxillary sinus or inferior alveolar nerve) or atrophic ridge. 3. Opposing natural teeth should be present. 4. The edentulous ridge should be free from any infection or remining root. 5. Patient should be able to tolerate surgical procedure of implant procedures physically and psychologically. 6. Patient should be willing to return for follow-up examination and evaluation.
Who cannot join
- 1. Patients with active periodontal diseases. 2. Patient with poor oral hygiene and motivation. 3. Pregnant women. 4. Patient with unrealistic expectations. 5. Patients with parafunctional habits and smoker. 6. Patient with systemic disease and immunocompromised patients which will prevent surgical procedure. 7. Recent extraction or extraction socket with infection or remining root.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Stability, Marginal Bone Loss and Occlusal Load Analysis of Customized Posterior Hybrid PEEK Abutments Supported by Short Implants
this study will be directed toward evaluating stability, marginal bone loss and occlusal load of posterior customized PEEK abutments on Ti-bases supported by short implant
Read the detailed description
although short implant solved many clinical problems; it is sometimes associated with loss of osseointegration which is firstly expressed by peri-implantitis and marginal bone loss. Also, PEEK is a very promising material characterized by low modulus of elasticity thus it can act as a shock absorber. Whether constructing superstructure components of short implant from PEEK will improve their performance or not is lacking in the dental literature.
To conduct the present study, the following will be used:
- Customized screw retained PEEK abutment/crown on a Ti base.
- Prefabricated titanium abutment.
- Short implant. The study will be conducted on 12 patients with missing single posterior tooth indicated for short implants) near anatomical structure or atrophic ridge), attending the outpatient clinic of the Crowns and Bridges department, Faculty of Dental Medicine for Girls, Al-Azhar University.
- Being tested
- customization of abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customization of abutmentOther
we will customize abutment for every patient not ready made
| Study group | Role | What they receive |
|---|---|---|
| Customized PEEK abutment/ crown on a Ti base. | Active comparator | Not described Receives: Other: customization of abutment |
| Prefabricated titanium abutment, supporting ceramometal separate crown. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease marginal bone loss around short implant
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study startAug 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Bone Loss and Loss of Osteointegration of Short ImplantStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shahenda Tarek Abu Amu, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972240
- Sponsor's protocol ID
- P-CR-21-03
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Stability, Marginal Bone Loss and Occlusal Load Analysis of Customized Posterior Hybrid PEEK Abutments Supported by Short Implants
- ClinicalTrials.gov ID
- NCT04972240
- Acronym / sponsor ID
- P-CR-21-03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- Aug 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 22 Jul 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.
this study will be directed toward evaluating stability, marginal bone loss and occlusal load of posterior customized PEEK abutments on Ti-bases supported by short implant
Detailed description
although short implant solved many clinical problems; it is sometimes associated with loss of osseointegration which is firstly expressed by peri-implantitis and marginal bone loss. Also, PEEK is a very promising material characterized by low modulus of elasticity thus it can act as a shock absorber. Whether constructing superstructure components of short implant from PEEK will improve their performance or not is lacking in the dental literature.
To conduct the present study, the following will be used:
- Customized screw retained PEEK abutment/crown on a Ti base.
- Prefabricated titanium abutment.
- Short implant. The study will be conducted on 12 patients with missing single posterior tooth indicated for short implants) near anatomical structure or atrophic ridge), attending the outpatient clinic of the Crowns and Bridges department, Faculty of Dental Medicine for Girls, Al-Azhar University.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customized PEEK abutment/ crown on a Ti base. | Active comparator | Other: customization of abutment |
| Prefabricated titanium abutment, supporting ceramometal separate crown. | No intervention | – |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Age range of patients 30-45 years old, with no gender prediction, able to read and sign the informed consent. 2. Patient with missing posterior tooth indicated for replacement with short implant as there are any anatomical limitation (near maxillary sinus or inferior alveolar nerve) or atrophic ridge. 3. Opposing natural teeth should be present. 4. The edentulous ridge should be free from any infection or remining root. 5. Patient should be able to tolerate surgical procedure of implant procedures physically and psychologically. 6. Patient should be willing to return for follow-up examination and evaluation.
Key exclusion criteria (1 listed)
- 1. Patients with active periodontal diseases. 2. Patient with poor oral hygiene and motivation. 3. Pregnant women. 4. Patient with unrealistic expectations. 5. Patients with parafunctional habits and smoker. 6. Patient with systemic disease and immunocompromised patients which will prevent surgical procedure. 7. Recent extraction or extraction socket with infection or remining root.
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 |
|---|---|---|
| customization of abutmentwe will customize abutment for every patient not ready made | Other | Customized PEEK abutment/ crown on a Ti base. |
Primary outcome
decrease marginal bone loss around short implant
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: Yes
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 customization of abutment in people with Marginal Bone Loss and Loss of Osteointegration of Short Implant, run by Faculty of Dental Medicine for Girls 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 1 inclusion and 1 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 4 Aug 2021. 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?
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?
decrease marginal bone loss around short implant (time frame: one 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 4 Aug 2021.