Will Laser Treated Dental Implants Improve Stability Early HealingNCT04100382
Laser Treated vs SLA Treated Short Implants in Terms of Stability.
A study testing Laser and SLA in people with Will Laser Treated Dental Implants Improve Stability Early Healing, run by Cairo University.
Trial summary
Laser treated short dental implants will be placed in a posterior atrophic ridge with only 8-10 mm available bone height. Their stability will be measured through a period of 12 weeks. They will be compared to the stability of SLA treated Short dental implants placed in the same situations. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Will Laser Treated Dental Implants Improve Stability Early Healing
- What is being tested?
- Laser and SLA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2019to 15 Sep 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Adult patients with Edentulous posterior maxillae with insufficient ridge for placement of standard length dental implant, but allowing placement of short 8mm dental implant.
- Males and females.
Who cannot join
- • Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
- Patients suffering from immunodeficiency, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
- Intraoral soft and hard tissue pathology.
About this study
Official title: Implant Stability in Laser Treated Surface vs SLA Treated Short Implants (Randomized Clinical Trial)
Laser treated short dental implants will be placed in a posterior atrophic ridge with only 8-10 mm available bone height. Their stability will be measured through a period of 12 weeks. They will be compared to the stability of SLA treated Short dental implants placed in the same situations.
Read the detailed description
Laser treated short dental implants will be placed in a posterior atrophic ridge with only 8-10 mm available bone height. Their stability will be measured through a period of 12 weeks. They will be compared to the stability of SLA treated Short dental implants placed in the same situations.
- Being tested
- Laser and SLA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser and SLADevice
Patients will be randomized into two groups, control group for SLA implants, and study group will receive the Laser treated implants. Implants will be placed classically in the posterior maxillary region and their stability will be measured by ISQ device at the placement. Measurements will be taken again at 2, 4, 6, 8 , 10 and 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Laser and SLA implants | Experimental | Surgical placement of short implants in maxillary posterior teeth with Laser surface treated and SLA surface treated dental implants Receives: Device: Laser and SLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in implant stability at base line, 2,4,8, 12 weeks
measuring implant stability with resonance frequency analysis device using implant stability quotation (ISQ) that measures the stiffness and deflection of implant bone complex.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start15 Sep 2019 (estimated)
- Primary completion15 Sep 2020 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Will Laser Treated Dental Implants Improve Stability Early HealingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Alaa Diab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100382
- Sponsor's protocol ID
- 1719
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2019
- Last updated
- 24 Sep 2019
- 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 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant Stability in Laser Treated Surface vs SLA Treated Short Implants (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04100382
- Acronym / sponsor ID
- 1719
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (estimated)
- Primary completion
- 15 Sep 2020 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 24 Sep 2019 (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.
Laser treated short dental implants will be placed in a posterior atrophic ridge with only 8-10 mm available bone height. Their stability will be measured through a period of 12 weeks. They will be compared to the stability of SLA treated Short dental implants placed in the same situations.
Detailed description
Laser treated short dental implants will be placed in a posterior atrophic ridge with only 8-10 mm available bone height. Their stability will be measured through a period of 12 weeks. They will be compared to the stability of SLA treated Short dental implants placed in the same situations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser and SLA implants | Experimental | Device: Laser and SLASurgical placement of short implants in maxillary posterior teeth with Laser surface treated and SLA surface treated dental implants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- • Adult patients with Edentulous posterior maxillae with insufficient ridge for placement of standard length dental implant, but allowing placement of short 8mm dental implant.
Key exclusion criteria (6 listed)
- • Heavy smokers more than 20 cigarettes per day.
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 and SLAPatients will be randomized into two groups, control group for SLA implants, and study group will receive the Laser treated implants. Implants will be placed classically in the posterior maxillary region and their stability will be measured by ISQ device at the placement. Measurements will be taken again at 2, 4, 6, 8 , 10 and 12 weeks. | Device | Laser and SLA implants |
Primary outcome
Rate of change in implant stability at base line, 2,4,8, 12 weeks
Time frame: 3 months
measuring implant stability with resonance frequency analysis device using implant stability quotation (ISQ) that measures the stiffness and deflection of implant bone complex.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
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 Laser and SLA in people with Will Laser Treated Dental Implants Improve Stability Early Healing, 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 2 inclusion and 6 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 24 Sep 2019. 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?
Rate of change in implant stability at base line, 2,4,8, 12 weeks (time frame: 3 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 24 Sep 2019.