Peri-implant MucositisNCT05800795
Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray
A study testing Er: YAG laser and plasma spray in people with Peri-implant Mucositis, run by Ain Shams University at 1 site in Egypt.
Trial summary
The attachment of peri implant soft tissue to the implant serves as a biological seal that can prevent the development of inflammatory peri-implant diseases. Presence of contaminants has been suggested to be associated with tissue damaging inflammation and titanium wear microparticles were demonstrated to activate… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Er: YAG laser and plasma spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2021to 22 Sep 2022
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients with age range from 20 to 45 years old.
- Patients need placement of fixed implant-supported prosthesis in maxillary arch.
- Patients who are medically free from any systemic diseases as evidenced by the health questionnaire, using modified Cornell medical index (Pendleton et al., 2004).
- patients with good oral hygiene (Plaque Index and bleeding on probing less than or equal to grade 1).
- Absence of any local conditions affecting bone-implant osseointegration (e.g., infection and poor bone density).
- The presence of sufficient bone width and height that permit the placement of implant with minimum diameter 3.5 mm and 8.5 mm length.
Who cannot join
- Presence of acute infections.
- Smokers.
- Pregnancy and lactation.
- Patients with a history of bisphosphonates therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray: A Randomized Controlled Clinical Study With Histological, and Scanning Electron Microscopic Analysis
The attachment of peri implant soft tissue to the implant serves as a biological seal that can prevent the development of inflammatory peri-implant diseases. Presence of contaminants has been suggested to be associated with tissue damaging inflammation and titanium wear microparticles were demonstrated to activate osteoclastic action. Er: YAG laser has been extensively investigated clinically for applications for treating periimplantitis either independently or in combination with other techniques, showing favorable outcomes. Plasma spray treatment can decontaminate surfaces without modifying their topography. It is also able to increase the surface energy by obtaining more hydrophilic surfaces, which may increase the capacity of the titanium oxide layer to interact with cells and proteins of surrounding tissue improving cell adhesion to the treated surface.
Read the detailed description
This study was conducted on 24 patients seeking implant placement. A total number of 33 healing abutments were included in this study, they were divided into 3 groups. Group 1 (Laser group): 8 patients in this group received 11 healing abutments treated with Er:YAG laser, group 2 (Plasma group): 8 patients in this group received 11 healing abutments treated with plasma sprayand group 3 (control group): 8 patients in this group received 11 healing abutments with no surface treatment.Three months after implants placement, patients included in the study were randomly assigned to one of the three study groups, second stage surgery was performed and patients received healing abutments without surface treatment in control group, surface treatment was performed in plasma and laser groups. After two weeks, clinical assessment was done using PI and GI before taking biopsies from peri-implant soft tissue for histological assessment. H\&E stain was used for measuring inflammatory cells count and Masson's Trichrome stains for measuring collagen fibers area fraction. Analysis of the abutments surface was done using SEM.
- Conditions
- Peri-implant Mucositis
- Being tested
- Er: YAG laser, plasma spray
- Keywords
- healing abutment, plasma spray, Er: YAG laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er: YAG laserDevice
surface treatment with Er: YAG laser for heating abutments
plasma sprayDevice
surface treatment with plasma spray for heating abutments
| Study group | Role | What they receive |
|---|---|---|
| laser group | Active comparator | Healing abutments have been treated by Er:YAG laser. The laser-machine (with a wavelength of 2.940 nm) was used with settings of 100 mJ/pulse (12.7 J/cm₂) and 10 Hz. The healing abutments' surface was thoroughly decontaminated by the fiber tip in a semicircular contact mode with copious water irrigation. Receives: Device: Er: YAG laser |
| plasma group | Active comparator | Healing abutments have been sprayed with an atmospheric pressure plasma device (Piezobrush® PZ2)
, by using active gas, low-temperature plasma treatment under irradiation at 0.2 MPa for a total of 80 seconds at 10 mm (20 seconds per each surface) Receives: Device: plasma spray |
| control group | No intervention | Healing abutments were installed as they came from industry and received no further treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
histological assessment measuring inflammatory cells count.
sections of biopsies from peri-implant soft tissue stained with hematoxylin and eosin stain.
H\&E stain was used for measuring inflammatory cells count and Masson's Trichrome stains for measuring collagen fibers area fraction.
Measured: two weeks after stage two surgery
histological assessment measuring collagen fibers area fraction.
sections of biopsies from peri-implant soft tissue stained with Masson trichrome stain.
Measured: two weeks after stage two surgery
Secondary outcomes (3)
scanning electron microscopic analysis
Analysis of the abutments surface was done using SEM
Measured: two weeks after stage two surgery
clinical assessment measuring plaque index
Clinical assessment was done using loe and silness plaque index score from 0 to 3
Measured: two weeks after stage two surgery and after three months
clinical assessment measuring gingival index
Clinical assessment was done using loe and silness gingival index score from 0 to 3
Measured: two weeks after stage two surgery and after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start20 Jun 2021
- Primary completion13 Jun 2022
- Study completion22 Sep 2022
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.
- 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
- comparison between three groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Yosri, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800795
- Sponsor's protocol ID
- FDASU-RecID021817
- Status last verified
- Apr 2023
- First submitted
- 5 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray: A Randomized Controlled Clinical Study With Histological, and Scanning Electron Microscopic Analysis
- ClinicalTrials.gov ID
- NCT05800795
- Acronym / sponsor ID
- FDASU-RecID021817
- Conditions
- Peri-implant Mucositis
- Keywords
- healing abutment, plasma spray, Er: YAG laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 6 Apr 2023 (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 attachment of peri implant soft tissue to the implant serves as a biological seal that can prevent the development of inflammatory peri-implant diseases. Presence of contaminants has been suggested to be associated with tissue damaging inflammation and titanium wear microparticles were demonstrated to activate osteoclastic action. Er: YAG laser has been extensively investigated clinically for applications for treating periimplantitis either independently or in combination with other techniques, showing favorable outcomes. Plasma spray treatment can decontaminate surfaces without modifying their topography. It is also able to increase the surface energy by obtaining more hydrophilic surfaces, which may increase the capacity of the titanium oxide layer to interact with cells and proteins of surrounding tissue improving cell adhesion to the treated surface.
Detailed description
This study was conducted on 24 patients seeking implant placement. A total number of 33 healing abutments were included in this study, they were divided into 3 groups. Group 1 (Laser group): 8 patients in this group received 11 healing abutments treated with Er:YAG laser, group 2 (Plasma group): 8 patients in this group received 11 healing abutments treated with plasma sprayand group 3 (control group): 8 patients in this group received 11 healing abutments with no surface treatment.Three months after implants placement, patients included in the study were randomly assigned to one of the three study groups, second stage surgery was performed and patients received healing abutments without surface treatment in control group, surface treatment was performed in plasma and laser groups. After two weeks, clinical assessment was done using PI and GI before taking biopsies from peri-implant soft tissue for histological assessment. H\&E stain was used for measuring inflammatory cells count and Masson's Trichrome stains for measuring collagen fibers area fraction. Analysis of the abutments surface was done using SEM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- comparison between three groups
| Arm | Type | Receives |
|---|---|---|
| laser group | Active comparator | Device: Er: YAG laserHealing abutments have been treated by Er:YAG laser. The laser-machine (with a wavelength of 2.940 nm) was used with settings of 100 mJ/pulse (12.7 J/cm₂) and 10 Hz. The healing abutments' surface was thoroughly decontaminated by the fiber tip in a semicircular contact mode with copious water irrigation. |
| plasma group | Active comparator | Device: plasma sprayHealing abutments have been sprayed with an atmospheric pressure plasma device (Piezobrush® PZ2) , by using active gas, low-temperature plasma treatment under irradiation at 0.2 MPa for a total of 80 seconds at 10 mm (20 seconds per each surface) |
| control group | No intervention | –Healing abutments were installed as they came from industry and received no further treatment. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female patients with age range from 20 to 45 years old.
- Patients need placement of fixed implant-supported prosthesis in maxillary arch.
- Patients who are medically free from any systemic diseases as evidenced by the health questionnaire, using modified Cornell medical index (Pendleton et al., 2004).
- patients with good oral hygiene (Plaque Index and bleeding on probing less than or equal to grade 1).
- Absence of any local conditions affecting bone-implant osseointegration (e.g., infection and poor bone density).
Key exclusion criteria (4 listed)
- Presence of acute infections.
- Smokers.
- Pregnancy and lactation.
- Patients with a history of bisphosphonates therapy.
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: YAG lasersurface treatment with Er: YAG laser for heating abutments | Device | laser group |
| plasma spraysurface treatment with plasma spray for heating abutments | Device | plasma group |
Primary outcome
histological assessment measuring inflammatory cells count.
Time frame: two weeks after stage two surgery
sections of biopsies from peri-implant soft tissue stained with hematoxylin and eosin stain. H\&E stain was used for measuring inflammatory cells count and Masson's Trichrome stains for measuring collagen fibers area fraction.
histological assessment measuring collagen fibers area fraction.
Time frame: two weeks after stage two surgery
sections of biopsies from peri-implant soft tissue stained with Masson trichrome stain.
3 secondary outcomes
scanning electron microscopic analysis
Time frame: two weeks after stage two surgery
clinical assessment measuring plaque index
Time frame: two weeks after stage two surgery and after three months
clinical assessment measuring gingival index
Time frame: two weeks after stage two surgery and after three 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 6 Apr 2023.
- 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.
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: YAG laser and plasma spray in people with Peri-implant Mucositis, 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 6 inclusion and 4 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 6 Apr 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?
histological assessment measuring inflammatory cells count. (time frame: two weeks after stage two surgery). 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 6 Apr 2023.