Peri-ImplantitisNCT03100435
Efficacy of Er:YAG Laser in Decontamination of Dental Implants: An In-Vitro Study
A study testing Er:YAG Laser and Carbon Fiber Curette in people with Peri-Implantitis, run by Tufts University at 1 site in United States.
Trial summary
The American Association of Oral and Maxillofacial Surgeons estimated that 69% of adults ages 35 to 44 have lost at least one permanent tooth. Dental implants have revolutionized dentistry by providing tooth-like replacement for missing teeth and a solution that is predictable with long-term success.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Er:YAG Laser and Carbon Fiber Curette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2017to 18 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of enough teeth to support the mouth guard.
- Subjects diagnosed with clinical health, gingivitis, or slight chronic periodontitis defined as periodontal inflammation with slight (1-2mm) attachment loss.
Who cannot join
- Subjects with insufficient dental support for the mouth guard
- Subjects diagnosed with moderate or severe chronic periodontitis.
- Subjects with known allergy to acrylic or titanium.
- Subjects who smoke cigarettes, cigars, snuff tobacco, or any other form of smoking.
- Subjects with a history of antibiotic treatment within the last six months.
- Subjects with contraindications to wearing a mouth guard, such as chronic obstructive pulmonary disease or severe sleep apnea.
- Subjects with uncontrolled or debilitating medical conditions, including but not limited to subjects with uncontrolled diabetes, hematologic disorders, cancers, immunosuppression, severe cardiovascular disease, or uncontrolled thyroid disease
- Subjects that are currently pregnant according to self-report
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
The American Association of Oral and Maxillofacial Surgeons estimated that 69% of adults ages 35 to 44 have lost at least one permanent tooth. Dental implants have revolutionized dentistry by providing tooth-like replacement for missing teeth and a solution that is predictable with long-term success..
After the implant is placed, natural bacteria from the mouth can develop around implants just like around natural teeth. Studies have shown that bacterial contamination can cause peri-implantitis- gum disease or inflammation around the implant, eventually leading to bone loss. Removing bacteria from dental implant surfaces can prevent peri-implantitis, and surface debridement constitutes the basis of treatment of peri-implant disease.
Read more
Typically, mechanical hand instrumentation using curettes to remove biofilm and calculus is the main basis for periodontal therapy. However, total debridement is difficult, and the hand tools may damage the surface of the implant and making it more plaque retentive. Studies have shown that mechanical non-surgical therapy alone is not sufficient to treat peri-implantitis.
There is evidence that a dental laser may be an effective method to remove bacteria from implant surfaces, with less damage to the surface. One type of dental laser, Er:YAG, appears optimal for implant decontamination as the Er:YAG laser energy is primarily absorbed by water, resulting in vaporization of bacteria and minimal surface alterations on the implant surface.The aim of this study is to evaluate the efficiency of biofilm decontamination of Er:YAG laser compared to carbon fiber curette.
Read the detailed description
The aim of this study is to compare the amount of residual biofilm on titanium discs after decontamination with Er:YAG laser and carbon fiber curette.
In the first phase of the study, custom mouth guards that holds multiple titanium discs will be fabricated. Experimental subjects will be instructed to wear this mouth guard for 72 hours, during which time a natural bacterial biofilm will form on the disc surfaces.
The second phase of the study will be performed ex vivo after collecting the discs from the subjects. Discs retrieved from each mouth guard will be randomized over the 4 treatment groups, so that each subject will contribute two discs to each treatment group: 1) Er:YAG laser, 2) carbon fiber curette, 3) combination of carbon fiber curette and Er:YAG laser, and 4) no treatment (control). The biofilm will be stained and the residual biofilm will be visualized under fluorescence microscopy. Statistical methods will be used to determine the significance of each treatment modality.
The primary outcome of the study is the percent area of the titanium disc covered by biofilm.
- Conditions
- Peri-Implantitis
- Being tested
- Er:YAG Laser, Carbon Fiber Curette
- 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:YAG LaserDevice
Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.
Carbon Fiber CuretteOther
Titanium disks will be decontaminated ex-vivo with carbon fiber curettes
| Study group | Role | What they receive |
|---|---|---|
| Er:YAG Laser | Experimental | Er:YAG Laser only Receives: Device: Er:YAG Laser |
| Carbon Fiber Curette | Active comparator | Carbon fiber curette only Receives: Other: Carbon Fiber Curette |
| Er:YAG Laser + Carbon Fiber Curette | Experimental | Combination of Er:YAG Laser and carbon fiber curette Receives: Device: Er:YAG Laser; Other: Carbon Fiber Curette |
| No Treatment | No intervention | No treatment (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Bacteria Biofilm
Percent area of the titanium disc covered by bacteria biofilm
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start20 Apr 2017
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- 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
- All participants will wear a mouth guard holding 8 titanium discs for 3 days, during which time a natural bacterial biofilm will form on the disc surfaces. After 3 days, the discs will be removed from the mouthguard, and treated ex vivo with different decontamination methods.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Gyurko, DMD, PhD, Tufts University
- Investigators
- Robert Gyurko, DMD, PhD, Principal investigator, TUSDM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100435
- Sponsor's protocol ID
- 12380
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2017
- Last updated
- 31 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Er:YAG Laser in Decontamination of Dental Implants: An In-Vitro Study
- ClinicalTrials.gov ID
- NCT03100435
- Acronym / sponsor ID
- 12380
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 31 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The American Association of Oral and Maxillofacial Surgeons estimated that 69% of adults ages 35 to 44 have lost at least one permanent tooth. Dental implants have revolutionized dentistry by providing tooth-like replacement for missing teeth and a solution that is predictable with long-term success..
After the implant is placed, natural bacteria from the mouth can develop around implants just like around natural teeth. Studies have shown that bacterial contamination can cause peri-implantitis- gum disease or inflammation around the implant, eventually leading to bone loss. Removing bacteria from dental implant surfaces can prevent peri-implantitis, and surface debridement constitutes the basis of treatment of peri-implant disease.
Typically, mechanical hand instrumentation using curettes to remove biofilm and calculus is the main basis for periodontal therapy. However, total debridement is difficult, and the hand tools may damage the surface of the implant and making it more plaque retentive. Studies have shown that mechanical non-surgical therapy alone is not sufficient to treat peri-implantitis.
There is evidence that a dental laser may be an effective method to remove bacteria from implant surfaces, with less damage to the surface. One type of dental laser, Er:YAG, appears optimal for implant decontamination as the Er:YAG laser energy is primarily absorbed by water, resulting in vaporization of bacteria and minimal surface alterations on the implant surface.The aim of this study is to evaluate the efficiency of biofilm decontamination of Er:YAG laser compared to carbon fiber curette.
Detailed description
The aim of this study is to compare the amount of residual biofilm on titanium discs after decontamination with Er:YAG laser and carbon fiber curette.
In the first phase of the study, custom mouth guards that holds multiple titanium discs will be fabricated. Experimental subjects will be instructed to wear this mouth guard for 72 hours, during which time a natural bacterial biofilm will form on the disc surfaces.
The second phase of the study will be performed ex vivo after collecting the discs from the subjects. Discs retrieved from each mouth guard will be randomized over the 4 treatment groups, so that each subject will contribute two discs to each treatment group: 1) Er:YAG laser, 2) carbon fiber curette, 3) combination of carbon fiber curette and Er:YAG laser, and 4) no treatment (control). The biofilm will be stained and the residual biofilm will be visualized under fluorescence microscopy. Statistical methods will be used to determine the significance of each treatment modality.
The primary outcome of the study is the percent area of the titanium disc covered by biofilm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All participants will wear a mouth guard holding 8 titanium discs for 3 days, during which time a natural bacterial biofilm will form on the disc surfaces. After 3 days, the discs will be removed from the mouthguard, and treated ex vivo with different decontamination methods.
| Arm | Type | Receives |
|---|---|---|
| Er:YAG Laser | Experimental | Device: Er:YAG LaserEr:YAG Laser only |
| Carbon Fiber Curette | Active comparator | Other: Carbon Fiber CuretteCarbon fiber curette only |
| Er:YAG Laser + Carbon Fiber Curette | Experimental | Device: Er:YAG Laser, Other: Carbon Fiber CuretteCombination of Er:YAG Laser and carbon fiber curette |
| No Treatment | No intervention | –No treatment (control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of enough teeth to support the mouth guard.
- Subjects diagnosed with clinical health, gingivitis, or slight chronic periodontitis defined as periodontal inflammation with slight (1-2mm) attachment loss.
Key exclusion criteria (8 listed)
- Subjects with insufficient dental support for the mouth guard
- Subjects diagnosed with moderate or severe chronic periodontitis.
- Subjects with known allergy to acrylic or titanium.
- Subjects who smoke cigarettes, cigars, snuff tobacco, or any other form of smoking.
- Subjects with a history of antibiotic treatment within the last six months.
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 LaserTitanium disks will be decontaminated ex-vivo with the Er:YAG laser. | Device | Er:YAG Laser, Er:YAG Laser + Carbon Fiber Curette |
| Carbon Fiber CuretteTitanium disks will be decontaminated ex-vivo with carbon fiber curettes | Other | Carbon Fiber Curette, Er:YAG Laser + Carbon Fiber Curette |
Primary outcome
Percent Bacteria Biofilm
Time frame: 3 days
Percent area of the titanium disc covered by bacteria biofilm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Robert Gyurko, DMD, PhD principal investigator
TUSDM
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 Carbon Fiber Curette in people with Peri-Implantitis, run by Tufts University at 1 site in United States.
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 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: finished, as of the sponsor's last update on 31 Mar 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 United States. 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?
Yes. Results are posted in the registry (first posted 31 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Bacteria Biofilm (time frame: 3 days). 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 31 Mar 2023.