Peri-Implantitis
Conditions
Brief 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.. 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.
Interventions
DEVICEEr:YAG Laser
Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.
OTHERCarbon Fiber Curette
Titanium disks will be decontaminated ex-vivo with carbon fiber curettes
Sponsors
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Bacteria Biofilm | 3 days | Percent area of the titanium disc covered by bacteria biofilm |
Countries
United States
Participant flow
Recruitment details
From May 2017 to August 2018, 8 enrollments were made in the Department of Periodontology at Tufts University School of Dental Medicine
Pre-assignment details
Each subject participates in each arm, as 2 titanium discs from each subject are distributed among all 4 arms.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Titanium disks are decontaminated ex-vivo with the Er:YAG laser, with carbon fiber curettes, with titanium brush, or are not decontaminated . | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 31.6 years STANDARD_DEVIATION 1.5 |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants |
| Race/Ethnicity, Customized Indian | 1 Participants |
| Race/Ethnicity, Customized White | 1 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 2 / 8 | 2 / 8 | 2 / 8 | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Percent Bacteria Biofilm
Percent area of the titanium disc covered by bacteria biofilm
Time frame: 3 days
Population: From 64 collected titanium disks, 5 were removed from analysis. 4 disks were dislodged from 2 enrolled participants and 1 disk was excluded due to improper magnification of the SYTO 9 imaging.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser | Percent Bacteria Biofilm | 32.78 percentage of disc covered | Standard Deviation 24 |
| Curette | Percent Bacteria Biofilm | 20.14 percentage of disc covered | Standard Deviation 19.15 |
| Brush | Percent Bacteria Biofilm | 11.8 percentage of disc covered | Standard Deviation 10.29 |
| Control | Percent Bacteria Biofilm | 74.03 percentage of disc covered | Standard Deviation 21.61 |