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| Name | Class |
|---|---|
| Stony Brook University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test - stabilized chlorine dioxide rinse | Experimental | Subjects will receive CloSYS Ultra Sensitive Rinse |
|
| Placebo - oral rinse, no active ingredients | Placebo Comparator | Subjects will receive oral rinse - no active ingredients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stabilized chlorine dioxide oral rinse | Drug | Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
| 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. | 90 days |
| 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. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srinivas RM Venkatasatya, DDS, PhD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University | Stony Brook | New York | 11794-8703 | United States |
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No event occurred before participant enrollment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The focus of the analysis is on the teeth. The study will evaluate the outcome for all teeth as well as compare the outcomes between teeth and implants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo - Oral Rinse, no Active Ingredients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | mm | 90 days | Teeth | Teeth |
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bitterness in the mouth | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Srinivas Rao Myneni Venkatasatya, DDS, PhD | Stony Brook University | 631-632-8739 | srinivas.MyneniVenkatasatya@stonybrookmedicine.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2021 | Apr 10, 2021 | Prot_SAP_000.pdf |
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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.
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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.
| Placebo | Other | Patients received a rinse containing no active ingredients and periodontal basic therapy. |
|
Subjects will receive oral rinse - no active ingredients Placebo: Patients received a rinse containing no active ingredients and periodontal basic therapy. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| 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. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | score on a scale | 90 days | Number of Teeth | Number of Teeth |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | score on a scale | 90 days | Number of Teeth | Number of Teeth |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 3 |
| 29 |
| EG001 | 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. | 0 | 28 | 0 | 28 | 1 | 28 |
| Unrelated injury | Social circumstances | Non-systematic Assessment | Patient sustained knee injury through a fall in the bathroom and was unable to complete the study |
|
| Scheduling Issues | Social circumstances | Non-systematic Assessment |
|
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