Periodontitis Chronic Generalized Moderate, Periodontitis Chronic Generalized Severe
Conditions
Keywords
Laser Therapy, Non-surgical periodontal therapy, Scaling and root planing
Brief summary
The use of lasers to treat various problems in dentistry is growing as it has in medicine. One application is the use of lasers to treat periodontal disease. It has been suggested that the laser may reduce the need for surgical treatment by reducing pockets. The goal of this study is to evaluate the effectiveness of laser treatment for periodontal disease. Laser therapy will be used in addition to traditional non-surgical scaling and root planing (deep cleaning). The information obtained from this study will provide an objective assessment of adjunctive laser therapy compared to conventional periodontal therapy and will attempt to show the benefits, if any, lasers can provide in the treatment of chronic periodontal disease.
Interventions
DEVICELaser Therapy
Adjunctive application of laser therapy in the periodontal pocket
PROCEDURENon-surgical Scaling and Root Planing
Scaling to remove calculus deposits and root planing to smooth root surfaces
Sponsors
Biolase Inc
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, Controlled, Split-mouth
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years old or older (male or female) * Healthy without systemic diseases that may adversely effect healing * Not pregnant and no current plans to become pregnant * No periodontal treatment in the previous 12 months * No systemic antibiotic therapy in the previous 6 months * At least two quadrants with periodontitis (ideally opposite side same jaw) * Each quadrant must have two or more sites with probing pocket depths ≥ 5mm * Each quadrant should include interproximal intrabony defect(s)
Exclusion criteria
* Any systemic disease, medication, or habit known to adversely influence bone metabolism and/or wound healing: * Poorly controlled diabetes (HbA1c \> 7%) * History of bisphosphonate medications * History of radiation therapy affecting the proposed treatment site(s) * History of immunosuppressive medications (e.g. corticosteroids) * History of tobacco use (current or past tobacco use within the past 1 year) * Immune compromise caused by disease, treatment or other condition * Recent history of periodontal surgery (within the previous 2 years) * Recent history of scaling and root planing (within the previous 12 months) * Any condition that contraindicates periodontal therapy including surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing Pocket Depth | 12 months | This is a measure from base of pocket to gingival margin. |
| Sites That Bleed on Probing | 12 months | Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement. |
| Gingival Recession | 12 months | Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction. |
| Clinical Attachment Level | 12 months | Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal Microbiome | 12 months | Assess changes in periodontal microbiome using DNA sequencing |
| Patient Reported Outcomes: VAS Questionnaire | 12 months | Measure patient reported pain (0-100), comfort (0-100), sensitivity (0-100) and satisfaction (0-100) using VAS questionnaire, with lower values indicating better outcome for pain and sensitivity and higher values indicating better outcome for comfort and satisfaction. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Periodontal Sites Assigned to SRP + Adjunctive Laser Therapy or SRP Alone Enrolled participants each had multiple periodontal sites randomly assigned to receive scaling and root planing as conventional non-surgical periodontal therapy, or Laser therapy as an adjunct to scaling and root planing. | 17 |
| Pilot Procedure Arm Preliminary enrollment of individuals to pilot-test the protocol | 6 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Pilot Procedure Arm | Total | Periodontal Sites Assigned to SRP + Adjunctive Laser Therapy or SRP Alone |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 22 Participants | 16 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 6 participants | 17 participants | 17 participants |
| Sex: Female, Male Female | 2 Participants | 14 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 | 0 / 5 |
| other Total, other adverse events | 0 / 17 | 0 / 17 | 0 / 5 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 5 |
Outcome results
Primary
Clinical Attachment Level
Periodontal clinical attachment level following treatment. This is a calculation (clinical attachment level = probing pocket depth + gingival recession).
Time frame: 12 months
Population: 15 participants had a total of 90 periodontal pockets, randomized 45 to Test and 45 to Control interventions. Each site had one buccal and one lingual measurement, with measures \<4mm excluded from analyses. Pilot enrollees were not assessed for outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Adjunctive Laser Therapy | Clinical Attachment Level | 5.346 mm | Standard Deviation 1.578 |
| SRP Alone | Clinical Attachment Level | 5.455 mm | Standard Deviation 1.766 |
Primary
Gingival Recession
Measure of gingival recession following treatment. This is a measure of the gingival margin from the cement-enamel junction.
Time frame: 12 months
Population: 15 participants had a total of 90 periodontal pockets, randomized 45 to Test and 45 to Control interventions. Each site had one buccal and one lingual measurement, with measures \<4mm excluded from analyses. Pilot enrollees were not assessed for outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Adjunctive Laser Therapy | Gingival Recession | 1.167 mm | Standard Deviation 1.263 |
| SRP Alone | Gingival Recession | 1.182 mm | Standard Deviation 1.305 |
Primary
Probing Pocket Depth
This is a measure from base of pocket to gingival margin.
Time frame: 12 months
Population: 15 participants had a total of 90 periodontal pockets, randomized 45 to Test and 45 to Control interventions. Each site had one buccal and one lingual measurement, with measures \< 4mm excluded from analyses. The preliminary pilot participants were not assessed for outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Adjunctive Laser Therapy | Probing Pocket Depth | 4.167 mm | Standard Deviation 0.986 |
| SRP Alone | Probing Pocket Depth | 4.273 mm | Standard Deviation 1.232 |
Primary
Sites That Bleed on Probing
Percentage of sites that bleed in response to probing. Bleeding observed within 30 seconds from pocket/sulcus following periodontal probe measurement.
Time frame: 12 months
Population: 15 participants had a total of 90 periodontal pockets, randomized 45 to Test and 45 to Control interventions. Each site had one buccal and one lingual measurement, with measures \<4mm excluded from analyses. Pilot enrollees were not assessed for outcome measures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SRP + Adjunctive Laser Therapy | Sites That Bleed on Probing | 55.1 percentage of sites with bleeding |
| SRP Alone | Sites That Bleed on Probing | 63.6 percentage of sites with bleeding |
Secondary
Patient Reported Outcomes: VAS Questionnaire
Measure patient reported pain (0-100), comfort (0-100), sensitivity (0-100) and satisfaction (0-100) using VAS questionnaire, with lower values indicating better outcome for pain and sensitivity and higher values indicating better outcome for comfort and satisfaction.
Time frame: 12 months
Population: 15 participants had a total of 90 sites (periodontal pockets), randomized 45 to Test and 45 to Control interventions. Pilot enrollees were not assessed for outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SRP + Adjunctive Laser Therapy | Patient Reported Outcomes: VAS Questionnaire | Pain | 2.316 units on a scale | Standard Deviation 6.634 |
| SRP + Adjunctive Laser Therapy | Patient Reported Outcomes: VAS Questionnaire | Satisfaction | 99.579 units on a scale | Standard Deviation 1.853 |
| SRP + Adjunctive Laser Therapy | Patient Reported Outcomes: VAS Questionnaire | Comfort | 100 units on a scale | Standard Deviation 0 |
| SRP + Adjunctive Laser Therapy | Patient Reported Outcomes: VAS Questionnaire | Sensitivity | 16.158 units on a scale | Standard Deviation 30.848 |
| SRP Alone | Patient Reported Outcomes: VAS Questionnaire | Satisfaction | 99.611 units on a scale | Standard Deviation 1.65 |
| SRP Alone | Patient Reported Outcomes: VAS Questionnaire | Pain | 1.056 units on a scale | Standard Deviation 3.334 |
| SRP Alone | Patient Reported Outcomes: VAS Questionnaire | Sensitivity | 20.833 units on a scale | Standard Deviation 32.787 |
| SRP Alone | Patient Reported Outcomes: VAS Questionnaire | Comfort | 100 units on a scale | Standard Deviation 0 |
Secondary
Periodontal Microbiome
Assess changes in periodontal microbiome using DNA sequencing
Time frame: 12 months
Population: Microbiome results will not be available for analysis until April 2021