Complete EdentulismNCT04686370
Effect of Different Implant Surface Treatments on Bony Changes Around Mandibular Implants
A study testing laser treated implant surface in people with Complete Edentulism, run by Cairo University at 1 site in Egypt.
Trial summary
The research will be conducted to report which type of surface treatment of dental implants that can be successful and aids in increasing bone to implant contact and how it affects the bony changes around the implants installed in mandibular arches for completely edentulous patients or whether there are specific… Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- laser treated implant surface
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2020to Oct 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completely edentulous patients
- Angle's class 1 skeletal relationship
- Normal facial asymmetry
- Cooperative patients
- Adequate inter-arch spcae not less than 12mm
Who cannot join
- Tempromandibular joint disorder
- Uncontrolled diabetes
- Bleeding disorders or anticoagulant therapy
- Flabby tissues or sharp mandibular residual ridge
- Heavy smoker
- Patient's with neuromuscular disorders
- Patients on chemotherapy or radiotherapy
- Severe psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Implant Surface Treatments on Bony Changes Around Mandibular Implants for Completely Edentulous Patients (A Split-mouth Comparative Study)
The research will be conducted to report which type of surface treatment of dental implants that can be successful and aids in increasing bone to implant contact and how it affects the bony changes around the implants installed in mandibular arches for completely edentulous patients or whether there are specific precautions to be taken into consideration during implant planning concerned with the type of surface microstructure treatment and recommendations needed.
Read the detailed description
Primary objective:
PICO P: Completely edentulous patients I: Laser surface treatment of implants C: Sandblasted Acid etched surface treatment O: Bony changes
Each Participants will have 2 implants;one laser surface treated implants and another sandblasted acid-etched implant (split-mouth) installed in the intra-foraminal area of mandibular arch prosthetically driven by the prepared conventional denture. MS and AF are responsible for delayed-loading of the denture and will measure bony changes around laser treated surface implants using radiographic assessment using long paralleling technique periapical digital x-ray(SOREDEX™ DIGORA™ Optime)
- Conditions
- Complete Edentulism
- Being tested
- laser treated implant surface
- Keywords
- Dental implant, Surface treatment, Laser, Sandblasted Acid-etched implants, Delayed-loading, Bony changes, Marginal bone loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser treated implant surfaceOther
Better marginal bone stability is expected for this type
| Study group | Role | What they receive |
|---|---|---|
| sandblasted acid-etched implants | Active comparator | implant will be installed intraforaminal Receives: Other: laser treated implant surface |
| laser treated implants | Experimental | implant will be installed intraforaminal Receives: Other: laser treated implant surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone stability around dental implants
Measuring amount of marginal bone loss by radiographic assessment using long paralleling technique periapical digital x-ray(SOREDEX™ DIGORA™ Optime)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start6 Oct 2020
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies 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
- Parallel groups
- Model description
- one single group will receive both types of dental implants (Split-mouth)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Mohamed Abdelsalam, Cairo University
- Investigators
- Marwan Mohamed, Investigator, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686370
- Sponsor's protocol ID
- 20-2-34
- Status last verified
- Dec 2020
- First submitted
- 25 Nov 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Implant Surface Treatments on Bony Changes Around Mandibular Implants for Completely Edentulous Patients (A Split-mouth Comparative Study)
- ClinicalTrials.gov ID
- NCT04686370
- Acronym / sponsor ID
- 20-2-34
- Conditions
- Complete Edentulism
- Keywords
- Dental implant, Surface treatment, Laser, Sandblasted Acid-etched implants, Delayed-loading, Bony changes, Marginal bone loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 28 Dec 2020 (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 research will be conducted to report which type of surface treatment of dental implants that can be successful and aids in increasing bone to implant contact and how it affects the bony changes around the implants installed in mandibular arches for completely edentulous patients or whether there are specific precautions to be taken into consideration during implant planning concerned with the type of surface microstructure treatment and recommendations needed.
Detailed description
Primary objective:
PICO P: Completely edentulous patients I: Laser surface treatment of implants C: Sandblasted Acid etched surface treatment O: Bony changes
Each Participants will have 2 implants;one laser surface treated implants and another sandblasted acid-etched implant (split-mouth) installed in the intra-foraminal area of mandibular arch prosthetically driven by the prepared conventional denture. MS and AF are responsible for delayed-loading of the denture and will measure bony changes around laser treated surface implants using radiographic assessment using long paralleling technique periapical digital x-ray(SOREDEX™ DIGORA™ Optime)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- one single group will receive both types of dental implants (Split-mouth)
| Arm | Type | Receives |
|---|---|---|
| sandblasted acid-etched implants | Active comparator | Other: laser treated implant surfaceimplant will be installed intraforaminal |
| laser treated implants | Experimental | Other: laser treated implant surfaceimplant will be installed intraforaminal |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Completely edentulous patients
- Angle's class 1 skeletal relationship
- Normal facial asymmetry
- Cooperative patients
- Adequate inter-arch spcae not less than 12mm
Key exclusion criteria (8 listed)
- Tempromandibular joint disorder
- Uncontrolled diabetes
- Bleeding disorders or anticoagulant therapy
- Flabby tissues or sharp mandibular residual ridge
- Heavy smoker
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 |
|---|---|---|
| laser treated implant surfaceBetter marginal bone stability is expected for this type | Other | laser treated implants, sandblasted acid-etched implants |
Primary outcome
Marginal bone stability around dental implants
Time frame: 1 year
Measuring amount of marginal bone loss by radiographic assessment using long paralleling technique periapical digital x-ray(SOREDEX™ DIGORA™ Optime)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Marwan Mohamed, Investigator principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser treated implant surface in people with Complete Edentulism, run by Cairo 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 5 inclusion and 8 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 28 Dec 2020. 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?
Marginal bone stability around dental implants (time frame: 1 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 28 Dec 2020.