Implant Site ReactionNCT04092920
Implant Stability of Laser vs SLA Surface Treated Implants Placed in Fresh Extraction Sockets
A study testing laser and SLA in people with Implant Site Reaction, run by Cairo University at 1 site in Egypt.
Trial summary
Commercially available implant surfaces are moderately roughened surfaces and they are obtained by acid-etching following alumina or titanium oxide grit-blasting. Although the micro-rough implants can be successful in compromised clinical scenarios, the bioinert nature of titanium surfaces cannot stimulate a more… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Implant Site Reaction
- 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
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2019to 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with badly broken teeth indicated for extraction. • Presence of adequate bone beyond the root apex to guarantee implant primary stability \& implant placement within the alveoli confines.
Who cannot join
- • Presence of acute infections in the implant site.
- Presence of fenestrations or dehiscence of the residual bony walls after extraction.
- 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.
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University
Cairo
amr hosny el khadem, associate professor, 01001162401, amr.elkhadem@dentistry.cu.edu.eg
magdy zarea, 0201144252034, magdyzarea@yahoo.com
About this study
Official title: Primary Implant Stability of Laser Surface Treated Versus Sand Blasted/Acid Etched Surface Treated Implants in Fresh Extraction Sockets: A Randomized Clinical Trial
Commercially available implant surfaces are moderately roughened surfaces and they are obtained by acid-etching following alumina or titanium oxide grit-blasting.
Although the micro-rough implants can be successful in compromised clinical scenarios, the bioinert nature of titanium surfaces cannot stimulate a more rapid bone regeneration and mechanical fixation of dental implants.
Laser surface treatment is used to produce an implant surface modification on the nano-scale with controlled and reproducible patterns in addition to exhibiting a sterilizing effect and achieving efficient oxidation .
Read the detailed description
For dental implant to be successful, a direct contact between the bone tissue and the surface of the implant should be developed \& this physiological phenomenon is known by the term of osseointegration.
Initially, it was supposed that to achieve osseointegration, implants had to be submerged under the mucosa \& left without any loading for a period of 3-4 months in mandible and 6-8 months in maxilla.
Recently immediate implant placement at the time of extraction has become a viable treatment alternative, this approach provides the advantages of decreasing the patient's discomfort, the treatment's duration and costs.
Aiming to reduce healing process to limit such changes in the soft \& hard tissues and reducing treatment time, several alterations in both surgical and restorative procedures has been introduced. From an implant design perspective, two approaches including the fields of biomaterials and/or biomechanics have been most utilized; implant body design which aim to increase the primary stability and surface modifications to allow faster osseointegration process.
Rough implant surface is modified by different techniques. Among these different techniques, interest in of using laser to achieve roughened surfaces.
Commercially available implant surfaces are moderately roughened surfaces and they are obtained by acid-etching following alumina or titanium oxide grit-blasting.
Although the micro-rough implants can be successful in compromised clinical scenarios, the bioinert nature of titanium surfaces cannot stimulate a more rapid bone regeneration and mechanical fixation of dental implants.
- Conditions
- Implant Site Reaction
- 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
ligible patients will be randomized to 2 groups control group will receive SLA surface treated implant to replace badly broken tooth immediately after extraction and a study group will receive laser surface treated implant to replace badly broken tooth immediately after extraction.
atraumatic extraction will be performed and socket will be examined for presence of bone dehesince or fenestration if no, implant will be placed immediately and a implant primary stability will be measured using an ISQ unit and recorded as base Line reading .
gingival former will be attached to the implant and removed at 2 ,4,8,12 week intervals to record ISQ readings.
| Study group | Role | What they receive |
|---|---|---|
| laser and SLA implants | Experimental | extraction of badly broken maxillary and mandibular teeth with immediate implant placement using 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 baseline,2,4,8,12 weeks
measuring implant stability with Resonance Frequency Analysis device using Implant stability quotient (ISQ) units that measure the stiffness and deflection of the 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 posted17 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed mohamed mohamed abd el maksoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092920
- Sponsor's protocol ID
- PRO 6-3-1
- 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
- Primary Implant Stability of Laser Surface Treated Versus Sand Blasted/Acid Etched Surface Treated Implants in Fresh Extraction Sockets: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04092920
- Acronym / sponsor ID
- PRO 6-3-1
- Conditions
- Implant Site Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 17 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.
Commercially available implant surfaces are moderately roughened surfaces and they are obtained by acid-etching following alumina or titanium oxide grit-blasting.
Although the micro-rough implants can be successful in compromised clinical scenarios, the bioinert nature of titanium surfaces cannot stimulate a more rapid bone regeneration and mechanical fixation of dental implants.
Laser surface treatment is used to produce an implant surface modification on the nano-scale with controlled and reproducible patterns in addition to exhibiting a sterilizing effect and achieving efficient oxidation .
Detailed description
For dental implant to be successful, a direct contact between the bone tissue and the surface of the implant should be developed \& this physiological phenomenon is known by the term of osseointegration.
Initially, it was supposed that to achieve osseointegration, implants had to be submerged under the mucosa \& left without any loading for a period of 3-4 months in mandible and 6-8 months in maxilla.
Recently immediate implant placement at the time of extraction has become a viable treatment alternative, this approach provides the advantages of decreasing the patient's discomfort, the treatment's duration and costs.
Aiming to reduce healing process to limit such changes in the soft \& hard tissues and reducing treatment time, several alterations in both surgical and restorative procedures has been introduced. From an implant design perspective, two approaches including the fields of biomaterials and/or biomechanics have been most utilized; implant body design which aim to increase the primary stability and surface modifications to allow faster osseointegration process.
Rough implant surface is modified by different techniques. Among these different techniques, interest in of using laser to achieve roughened surfaces.
Commercially available implant surfaces are moderately roughened surfaces and they are obtained by acid-etching following alumina or titanium oxide grit-blasting.
Although the micro-rough implants can be successful in compromised clinical scenarios, the bioinert nature of titanium surfaces cannot stimulate a more rapid bone regeneration and mechanical fixation of dental implants.
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 SLAextraction of badly broken maxillary and mandibular teeth with immediate implant placement using laser surface treated and SLA surface treated dental implants |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with badly broken teeth indicated for extraction. • Presence of adequate bone beyond the root apex to guarantee implant primary stability \& implant placement within the alveoli confines.
Key exclusion criteria (7 listed)
- • Presence of acute infections in the implant site.
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 SLAligible patients will be randomized to 2 groups control group will receive SLA surface treated implant to replace badly broken tooth immediately after extraction and a study group will receive laser surface treated implant to replace badly broken tooth immediately after extraction. atraumatic extraction will be performed and socket will be examined for presence of bone dehesince or fenestration if no, implant will be placed immediately and a implant primary stability will be measured using an ISQ unit and recorded as base Line reading . gingival former will be attached to the implant and removed at 2 ,4,8,12 week intervals to record ISQ readings. | Device | laser and SLA implants |
Primary outcome
rate of change in implant stability at baseline,2,4,8,12 weeks
Time frame: 3 months
measuring implant stability with Resonance Frequency Analysis device using Implant stability quotient (ISQ) units that measure the stiffness and deflection of the 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.
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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.
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 and SLA in people with Implant Site Reaction, 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 1 inclusion and 7 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.
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?
Contact ahmed mohamed mohamed abd el maksoud, bds (01061597677, drabdelmaksoud33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of change in implant stability at baseline,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.