Peri-implant MucositisNCT04905758
Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design
A study testing platform switching and platform amtching in people with Peri-implant Mucositis and Dental Implant Failed, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
patients were randomly divided into Maxi-Z plus dental implant group versus Maxi-Z implant group Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis, Dental Implant Failed
- What is being tested?
- platform switching and platform amtching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 15 Jun 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good health
- unrestorable, periodontal healthy teeth
Who cannot join
- systemic disease
- periodontal disease
- presence of abscess
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry, kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 214312
About this study
Official title: Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design: Randomised Clinical Study
patients were randomly divided into Maxi-Z plus dental implant group versus Maxi-Z implant group
Read the detailed description
after tooth extraction implants will be placed immediately and provisional restoration will be placed in both groups to detect the advantaged and drawbacks of newly designed Maxi-Z plus dental implant versus Maxi-Z dental implant
- Conditions
- Peri-implant Mucositis, Dental Implant Failed
- Being tested
- platform switching, platform amtching
- Keywords
- platform switched implants, platform matched implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platform switchingProcedure or surgery
reduced implant abutment interface
platform amtchingProcedure or surgery
matched implant abutment interface
| Study group | Role | What they receive |
|---|---|---|
| Maxi-Z plus dental implant | Experimental | platform switched dental implants Receives: Procedure: platform switching |
| Maxi-Z dental implant | Active comparator | platform matched dental implants Receives: Procedure: platform amtching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant mobility using Periotest M
Periotest M values range from (-8 to 0). high values represent loose implant, while osseointegrated implants showed low values
Measured: 12 months
marginal bone level
measured in mm using X-ray
Measured: 12 months
Secondary outcomes (1)
pink estheic score
from 0-12. 0 means bad aesthetic of soft tissue. 12 means the ultimate aesthetics of soft tissue
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Apr 2020
- Primary completion9 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant MucositisStudies 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
- Model description
- Maxi-Z plus dental implant
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Elamrousy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905758
- Sponsor's protocol ID
- assmortada2020
- Status last verified
- Jul 2021
- First submitted
- 26 May 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after research results publishing will decide
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design: Randomised Clinical Study
- ClinicalTrials.gov ID
- NCT04905758
- Acronym / sponsor ID
- assmortada2020
- Conditions
- Peri-implant Mucositis, Dental Implant Failed
- Keywords
- platform switched implants, platform matched implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 28 May 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.
patients were randomly divided into Maxi-Z plus dental implant group versus Maxi-Z implant group
Detailed description
after tooth extraction implants will be placed immediately and provisional restoration will be placed in both groups to detect the advantaged and drawbacks of newly designed Maxi-Z plus dental implant versus Maxi-Z dental implant
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Maxi-Z plus dental implant
| Arm | Type | Receives |
|---|---|---|
| Maxi-Z plus dental implant | Experimental | Procedure: platform switchingplatform switched dental implants |
| Maxi-Z dental implant | Active comparator | Procedure: platform amtchingplatform matched dental implants |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- good health
- unrestorable, periodontal healthy teeth
Key exclusion criteria (3 listed)
- systemic disease
- periodontal disease
- presence of abscess
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 switchingreduced implant abutment interface | Procedure or surgery | Maxi-Z plus dental implant |
| platform amtchingmatched implant abutment interface | Procedure or surgery | Maxi-Z dental implant |
Primary outcome
Implant mobility using Periotest M
Time frame: 12 months
Periotest M values range from (-8 to 0). high values represent loose implant, while osseointegrated implants showed low values
marginal bone level
Time frame: 12 months
measured in mm using X-ray
1 secondary outcome
pink estheic score
Time frame: 12 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 22 Jul 2021.
- Individual participant dataSharing planned: Yes. after research results publishing will decide
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platform switching and platform amtching in people with Peri-implant Mucositis and Dental Implant Failed, run by Kafrelsheikh University 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 2 inclusion and 3 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 22 Jul 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?
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?
Implant mobility using Periotest M (time frame: 12 months). The study lists 2 primary outcomes in all. 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 22 Jul 2021.