Peri-ImplantitisNCT05137821
Efficacy of Er: YSGG Laser in Treatment of Peri-implantitis
A study testing Er: YSGG laser and no therapy in people with Peri-Implantitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology in the treatment of peri-implantitis as a primary objective. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Er: YSGG laser and no therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2023to 15 Nov 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sex: female or male.
- Age: 25 - 55 years.
- Medically controlled according to medical coding of review of systems (ROS)
Who cannot join
- Tobacco smoking for at least 6 months before the study enrollment
- Participants with ill-fitting restorations in both upper first molars that affect the stability of the stent.
- Participants not following oral hygiene instructions.
- Participants on dental treatment during the study period.
- Participants with a history of drug administration
- Vulnerable group.
- Participants with long-term mouthwash administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Er: YSGG Laser on Oral Biofilm Removal From Implant Surface and Its Biological Response to Periodontal Tissues in Treatment of Peri-implantitis (An Ex Vivo Study)
This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology in the treatment of peri-implantitis as a primary objective.
To assess the morphological changes and the biological response (biocompatibility) of implant surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives.
Read the detailed description
This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology in the treatment of peri-implantitis as a primary objective.
To assess the morphological changes and the biological response (biocompatibility) of implant surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives.
The study was designed as an Ex Vivo study. Four periodontally and systemically healthy volunteers of both gender are included in this study for the formation of in vivo plaque biofilm. Each volunteer will wear a hard resin splint carrying six rough (machined implant; 3.3mm diameter, 8mm length) for 4 days to accumulate dental plaque naturally on the titanium surfaces of the implants.
Therefore, 24 implants will be assessed for Er: YSGG laser therapy in different bone defect simulators.
- Conditions
- Peri-Implantitis
- Being tested
- Er: YSGG laser, no therapy
- Keywords
- Er: YSGG laser therapy, Peri-Implantitis
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er: YSGG laserDevice
Er: YSGG laser decontamination of infected implant surfaces to simulate peri-implantitis therapy
no therapyOther
new sealed implant without any surface treatment
| Study group | Role | What they receive |
|---|---|---|
| non tested comparative group | Experimental | two sealed new implants as a control Receives: Other: no therapy |
| Er: YSGG laser tested group | Experimental | 24 infected implants divided into four subgroups that will be decontaminated by Er: YSGG laser in various peri-implant defects Receives: Device: Er: YSGG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual inspection of the oral biofilm removal efficacy by image analysis software (Adobe Photoshop
evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in
various peri-implant defect morphology
Measured: 2 weeks
Secondary outcomes (1)
Profilometer analysis of surface roughness changes
assess the morphological changes of implant surface after Er: YSGG laser therapy through Profilometer analysis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start10 Aug 2023
- Primary completion1 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- two group control and test group test group divided into four subgroups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alaa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137821
- Sponsor's protocol ID
- FDASU-REC ID210314
- Status last verified
- Nov 2023
- First submitted
- 1 Oct 2021
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Hashim A, Almalahy HG, El-Khazragy N, Kheir El Din NH. "Influence of peri-implantitis defect angles on morphology and the biocompatibility of the implant surfaces after Er, Cr: YSGG laser therapy: an ex vivo study". BMC Oral Health. 2026 Jul 22. doi: 10.1186/s12903-026-09278-3. Online ahead of print.
PubMed 42482019Hashim A, Kheir El Din NH, El-Khazragy N, Almalahy HG. Comparison of the efficacy of Er,Cr:YSGG laser on oral biofilm removal from implant surfaces with various application times for the treatment of peri-implantitis defects: ex vivo study. BMC Oral Health. 2024 Aug 22;24(1):980. doi: 10.1186/s12903-024-04698-5.
PubMed 39174958
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Er: YSGG Laser on Oral Biofilm Removal From Implant Surface and Its Biological Response to Periodontal Tissues in Treatment of Peri-implantitis (An Ex Vivo Study)
- ClinicalTrials.gov ID
- NCT05137821
- Acronym / sponsor ID
- FDASU-REC ID210314
- Conditions
- Peri-Implantitis
- Keywords
- Er: YSGG laser therapy, Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 30 Nov 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.
This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology in the treatment of peri-implantitis as a primary objective.
To assess the morphological changes and the biological response (biocompatibility) of implant surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives.
Detailed description
This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology in the treatment of peri-implantitis as a primary objective.
To assess the morphological changes and the biological response (biocompatibility) of implant surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives.
The study was designed as an Ex Vivo study. Four periodontally and systemically healthy volunteers of both gender are included in this study for the formation of in vivo plaque biofilm. Each volunteer will wear a hard resin splint carrying six rough (machined implant; 3.3mm diameter, 8mm length) for 4 days to accumulate dental plaque naturally on the titanium surfaces of the implants.
Therefore, 24 implants will be assessed for Er: YSGG laser therapy in different bone defect simulators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- two group control and test group test group divided into four subgroups
| Arm | Type | Receives |
|---|---|---|
| non tested comparative group | Experimental | Other: no therapytwo sealed new implants as a control |
| Er: YSGG laser tested group | Experimental | Device: Er: YSGG laser24 infected implants divided into four subgroups that will be decontaminated by Er: YSGG laser in various peri-implant defects |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sex: female or male.
- Age: 25 - 55 years.
- Medically controlled according to medical coding of review of systems (ROS)
Key exclusion criteria (7 listed)
- Tobacco smoking for at least 6 months before the study enrollment
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 |
|---|---|---|
| Er: YSGG laserEr: YSGG laser decontamination of infected implant surfaces to simulate peri-implantitis therapy | Device | Er: YSGG laser tested group |
| no therapynew sealed implant without any surface treatment | Other | non tested comparative group |
Primary outcome
visual inspection of the oral biofilm removal efficacy by image analysis software (Adobe Photoshop
Time frame: 2 weeks
evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology
1 secondary outcome
Profilometer analysis of surface roughness changes
Time frame: 1 month
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 21 Nov 2023.
- Derived from this study: PubMed 42482019Hashim A, Almalahy HG, El-Khazragy N, Kheir El Din NH. "Influence of peri-implantitis defect angles on morphology and the biocompatibility of the implant surfaces after Er, Cr: YSGG laser therapy: an ex vivo study". BMC Oral Health. 2026 Jul 22. doi: 10.1186/s12903-026-09278-3. Online ahead of print.
- Derived from this study: PubMed 39174958Hashim A, Kheir El Din NH, El-Khazragy N, Almalahy HG. Comparison of the efficacy of Er,Cr:YSGG laser on oral biofilm removal from implant surfaces with various application times for the treatment of peri-implantitis defects: ex vivo study. BMC Oral Health. 2024 Aug 22;24(1):980. doi: 10.1186/s12903-024-04698-5.
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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 Er: YSGG laser and no therapy in people with Peri-Implantitis, run by Ain Shams 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 3 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: finished, as of the sponsor's last update on 21 Nov 2023. 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?
visual inspection of the oral biofilm removal efficacy by image analysis software (Adobe Photoshop (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05137821, which also lists 2 linked publications.
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 21 Nov 2023.