Peri-implant Mucositis
Conditions
Brief summary
A full understanding of etiology and diagnosis of peri-implant diseases is crucial for finding effective treatments for these diseases that are more widely accessible to dentists. Several treatment protocols for peri-implant diseases have been proposed, but no gold standard has been established to date. Thus, the purpose of this study is to analyze efficacy of stabilized chlorine dioxide as a chemical adjuvant for treatment of peri-implant mucositis in a non-surgical treatment protocol with a 3-month follow-up.
Detailed description
Fifty individuals with peri-implant mucositis will be identified to participate in this study and randomized into two groups to analyze clinical parameters and results of this study: 1) test group (stabilized chlorine dioxide rinse) and 2) control group (placebo). Each group will be associated with periodontal basic therapy. Treatment Protocol After inclusion of the patients, medical history and initial examination are performed, patients will be randomly divided into the following two groups: 1) test (stabilized chlorine dioxide rinse associated with periodontal basic therapy); and 2) control (placebo associated with periodontal basic therapy). Periodontal basic therapy will consist of oral hygiene instruction, motivation, retentive factor removal, and an adaptation of the protocol of full-mouth scaling and root planing (stabilized chlorine dioxide mouthwash will be used). Plastic currets are used to instrument the implants and metal currets to instrument teeth. Immediately after instrumentation, chemical solutions of chlorine dioxide or placebo will be dispensed to the subjects. The subjects will follow their normal oral-hygiene procedures with the addition of using the study rinse toothbrush and toothpaste provided to them.
Interventions
DRUGStabilized chlorine dioxide oral rinse
Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.
OTHERPlacebo
Patients received a rinse containing no active ingredients and periodontal basic therapy.
Sponsors
Stony Brook University
Rowpar Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Once a subject has been screened and qualified for study participation, that subject will be enrolled and assigned the next available randomization number. The study randomization table will be generated by a third-party statistician. This procedure will be used to keep the Study Statistician blinded to subject treatments prior to database lock.
Intervention model description
Subjects will receive an Oral Hygiene Kit at Visit 1. The MGI, BOP and PI, Pocket depth and radiographs will be measured and all oral tissues examined (baseline examination). Subjects will return for Visit 2 in 14 days ± 3 days to: 1) assess and record changes in indices and oral health and any adverse conditions. Visit 3 (45 days ± 7) will be a compliance visit for study drug utilization. Visit 4 (90 days ± 7) will be a repeat of Visit 1.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of peri-implant mucositis * at least one implant * probing depth (PD) ≤5mm * BOP (bleeding on probing) * No radiographic evidence of bone loss beyond the first two threads of the implant
Exclusion criteria
* Active Periodontitis or Peri-implantitis which requires definitive treatment. * Presence of oral local mechanical factors that could (in the opinion of the PI) influence the outcome of the study. * Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed. * Presence of soft or hard tissue tumors of the oral cavity. * Patients treated with systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 12 weeks prior to study entry and throughout the study duration. * Patients chronically (i.e. two weeks or more) treated with non-steroidal anti-inflammatory drugs (NSAIDs) or any medications know to affect soft tissue condition (excluding treatment of Acetylsalicylic acid ≤ 100 mg/day). * Patients with uncontrolled diabetes, of any type, and/or patients with HbA1c test value \>7.5% dated 3 months prior to the screening visit. * Patients receiving radiation therapy to the head and neck area and/or receiving immunosuppressive therapy. * The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study. * Drug and alcohol abuse. * Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration. * Subject is pregnant (based on pregnancy result) or lactating. * Subject is a smoker, or has been a smoker within the past 6 months. * Any other condition that may interfere with the study as judged by the PI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Probing Depth | 90 days | The distance measured from the base of the pocket to the most apical point on the gingival margin. Measured in mms. Over 3 mm indicates a need for periodontal therapy. Higher results mean a worse outcome. |
| Global Plaque Score. | 90 days | The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, except the third molars. The index is calculated by dividing the number of plaque-containing surfaces by the total number of available surfaces. Values range from 0-18 with 0 being excellent and 18 poor. Higher numbers mean a worse outcome. |
| Modified Gingival Index (MGI) | 90 days | The MGI relies on a visual assessment of gingival changes to measure the severity of inflammation. Five categories, using a 0-4 scale, score the marginal and papillary gingival tissue based on color, texture, edema, and spontaneous bleeding. 0 being normal and 4 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding. The higher scores mean a worse outcome. |
Countries
United States
Participant flow
Recruitment details
57 Individuals with peri-implant muscositis were identified to participate in this study and randomized into 2 groups. Each group was associated with periodontal basic therapy.
Pre-assignment details
No event occurred before participant enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Test - Stabilized Chlorine Dioxide Rinse Subjects will receive CloSYS Ultra Sensitive Rinse
Stabilized chlorine dioxide oral rinse: Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy. | 29 |
| Placebo - Oral Rinse, no Active Ingredients Subjects will receive oral rinse - no active ingredients
Placebo: Patients received a rinse containing no active ingredients and periodontal basic therapy. | 28 |
| Total | 57 |
Baseline characteristics
| Characteristic | Test - Stabilized Chlorine Dioxide Rinse | Placebo - Oral Rinse, no Active Ingredients | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 17 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 11 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 26 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 22 Participants | 47 Participants |
| Sex: Female, Male Female | 12 Participants | 18 Participants | 30 Participants |
| Sex: Female, Male Male | 17 Participants | 10 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 3 / 29 | 1 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 |
Outcome results
Primary
Global Plaque Score.
The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, except the third molars. The index is calculated by dividing the number of plaque-containing surfaces by the total number of available surfaces. Values range from 0-18 with 0 being excellent and 18 poor. Higher numbers mean a worse outcome.
Time frame: 90 days
Population: 29 subjects in the test group and 28 subjects in the placebo group were enrolled. However, 2 subjects from the test group did not complete the study and therefore were excluded from the analysis. So 27 subjects in the test group and 28 placebo subjects were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test - Stabilized Chlorine Dioxide Rinse | Global Plaque Score. | 1.57 score on a scale | Standard Error 0.11 |
| Placebo - Oral Rinse, no Active Ingredients | Global Plaque Score. | 1.98 score on a scale | Standard Error 0.11 |
p-value: 0.011ANCOVA
Primary
Global Probing Depth
The distance measured from the base of the pocket to the most apical point on the gingival margin. Measured in mms. Over 3 mm indicates a need for periodontal therapy. Higher results mean a worse outcome.
Time frame: 90 days
Population: 29 subjects in the test group and 28 subjects in the placebo group were enrolled. However, 2 subjects from the test group did not complete the study and therefore were excluded from the analysis. So 27 subjects in the test group and 28 placebo subjects were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test - Stabilized Chlorine Dioxide Rinse | Global Probing Depth | 2.37 mm | Standard Error 0.166 |
| Placebo - Oral Rinse, no Active Ingredients | Global Probing Depth | 2.64 mm | Standard Error 0.13 |
p-value: 0.28ANCOVA
Primary
Modified Gingival Index (MGI)
The MGI relies on a visual assessment of gingival changes to measure the severity of inflammation. Five categories, using a 0-4 scale, score the marginal and papillary gingival tissue based on color, texture, edema, and spontaneous bleeding. 0 being normal and 4 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding. The higher scores mean a worse outcome.
Time frame: 90 days
Population: 29 subjects in the test group and 28 subjects in the placebo group were enrolled. However, 2 subjects from the test group did not complete the study and therefore were excluded from the analysis. So 27 subjects in the test group and 28 placebo subjects were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test - Stabilized Chlorine Dioxide Rinse | Modified Gingival Index (MGI) | 1.48 score on a scale | Standard Error 0.025 |
| Placebo - Oral Rinse, no Active Ingredients | Modified Gingival Index (MGI) | 1.52 score on a scale | Standard Error 0.035 |
p-value: <0.001ANCOVA