Bone LossNCT05066815
Evaluation of Crestal Bone Loss Around Short Dental Implants As Affected By Two Suprastructure Materials
A study testing Vita Enamic (Hybrid dental ceramic) in people with Bone Loss, run by Cairo University.
Trial summary
The aim of the study is to evaluate the crestal bone loss developed around short dental implants after using screw retained Hybrid ceramic crowns when compare to screw retained Lithium Di silicate based ceramic crowns. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- Vita Enamic (Hybrid dental ceramic)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2022to 1 Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients within age group of ≥ 18.
- There should be absence of any systemic diseases.
- Patients have missing simple posterior tooth
- Adequate interarch space.
- Inadequate residual bone height to place standard length implant.
- Patients with good oral hygiene.
Who cannot join
- A history that would complicate the outcome of the study, such as alcohol or drug dependency, smoking, poor health, or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontics treatment and required follow-up.
- Heavy smokers.
- Poorly controlled diabetes mellitus.
- Patients on radiotherapy.
- Patients with temporomandibular disorders
About this study
The aim of the study is to evaluate the crestal bone loss developed around short dental implants after using screw retained Hybrid ceramic crowns when compare to screw retained Lithium Di silicate based ceramic crowns.
Read the detailed description
This study will be conducted on patients requiring single implant replacement in the posterior regions of the mandible, admitted to the Outpatient Clinic of Fixed Prosthodontics Department, Faculty of Oral and Dental medicine, Cairo University.
Examination and diagnosis:
- Selection and examination of the patients according to inclusion and exclusion criteria.
- Preoperative Cone Beam Computed Tomography (CBCT) to all patients.
- Primary impression will be taken to produce study cast.
- Taking a professional photo for the examined posterior area.
- Patients will be divided into two group:
G1: Short implants will be restored by screw retained Hybrid ceramic crowns G2: Short implants will be restored by screw retained Lithium Di silicate based ceramic crowns
Surgical procedures:
- Implants will be placed following standardized protocol.
- After 4 months the patients re-attended for placement of healing abutments for about (10-14) days and prosthesis fabrication.
Data collection and post operative radio-logical assessment:
-Taking standardized digital peri-apical radio-graph by paralleling technique and film holding device for follow up at 12 months after crowns loading to evaluate crestal bone loss.
- Conditions
- Bone Loss
- Being tested
- Vita Enamic (Hybrid dental ceramic)
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vita Enamic (Hybrid dental ceramic)Other
Also called Polymer Infiltrated Ceramic Network (PICN)
Vita Enamic (Hybrid dental ceramic) is provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid superstructure | Experimental | screw retained hybrid ceramic crowns Receives: Other: Vita Enamic (Hybrid dental ceramic) |
| Ceramic superstructure | Active comparator | screw retained lithium disilicate based ceramic crowns Receives: Other: Vita Enamic (Hybrid dental ceramic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal Bone Loss Crestal bone loss will be measured using standardized digital periapical radiograph by paralleling technique and film holding device -measuring unit:Milimeters
preventive
Measured: one year
Secondary outcomes (1)
screw loosening of crowns screw loosening will be observed by clinical investigation -measuring unit:Binary (Yes/No)
preventive
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 posted4 Oct 2021
- Study start25 Oct 2022 (estimated)
- Primary completion25 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Nabil Ezz Eldin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066815
- Sponsor's protocol ID
- 211020
- Status last verified
- Jun 2022
- First submitted
- 11 Aug 2021
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Crestal Bone Loss Around Short Dental Implants As Affected By Two Suprastructure Materials
- ClinicalTrials.gov ID
- NCT05066815
- Acronym / sponsor ID
- 211020
- Conditions
- Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Oct 2022 (estimated)
- Primary completion
- 25 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 4 Oct 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.
The aim of the study is to evaluate the crestal bone loss developed around short dental implants after using screw retained Hybrid ceramic crowns when compare to screw retained Lithium Di silicate based ceramic crowns.
Detailed description
This study will be conducted on patients requiring single implant replacement in the posterior regions of the mandible, admitted to the Outpatient Clinic of Fixed Prosthodontics Department, Faculty of Oral and Dental medicine, Cairo University.
Examination and diagnosis:
- Selection and examination of the patients according to inclusion and exclusion criteria.
- Preoperative Cone Beam Computed Tomography (CBCT) to all patients.
- Primary impression will be taken to produce study cast.
- Taking a professional photo for the examined posterior area.
- Patients will be divided into two group:
G1: Short implants will be restored by screw retained Hybrid ceramic crowns G2: Short implants will be restored by screw retained Lithium Di silicate based ceramic crowns
Surgical procedures:
- Implants will be placed following standardized protocol.
- After 4 months the patients re-attended for placement of healing abutments for about (10-14) days and prosthesis fabrication.
Data collection and post operative radio-logical assessment:
-Taking standardized digital peri-apical radio-graph by paralleling technique and film holding device for follow up at 12 months after crowns loading to evaluate crestal bone loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid superstructure | Experimental | Other: Vita Enamic (Hybrid dental ceramic)screw retained hybrid ceramic crowns |
| Ceramic superstructure | Active comparator | Other: Vita Enamic (Hybrid dental ceramic)screw retained lithium disilicate based ceramic crowns |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients within age group of ≥ 18.
- There should be absence of any systemic diseases.
- Patients have missing simple posterior tooth
- Adequate interarch space.
- Inadequate residual bone height to place standard length implant.
Key exclusion criteria (5 listed)
- A history that would complicate the outcome of the study, such as alcohol or drug dependency, smoking, poor health, or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontics treatment and required follow-up.
- Heavy smokers.
- Poorly controlled diabetes mellitus.
- Patients on radiotherapy.
- Patients with temporomandibular disorders
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 |
|---|---|---|
| Vita Enamic (Hybrid dental ceramic)Also: Polymer Infiltrated Ceramic Network (PICN)Vita Enamic (Hybrid dental ceramic) is provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology. | Other | Ceramic superstructure, Hybrid superstructure |
Primary outcome
Crestal Bone Loss Crestal bone loss will be measured using standardized digital periapical radiograph by paralleling technique and film holding device -measuring unit:Milimeters
Time frame: one year
preventive
1 secondary outcome
screw loosening of crowns screw loosening will be observed by clinical investigation -measuring unit:Binary (Yes/No)
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 10 Jun 2022.
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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 Vita Enamic (Hybrid dental ceramic) in people with 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 6 inclusion and 5 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 10 Jun 2022. 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?
Crestal Bone Loss Crestal bone loss will be measured using standardized digital periapical radiograph by paralleling technique and film holding device -measuring unit:Milimeters (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 10 Jun 2022.