A Phase 4 interventional study of Stabilized chlorine dioxide oral rinse and Placebo in Peri-implant Mucositis, sponsored by Rowpar Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by Rowpar Pharmaceuticals, Inc. · Phase 4, Interventional, and Treatment
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.
265 studies on the registry are indexed under Mucositis; 34 are open to participants now.
This study's enrollment of 57 is above the median of 45 across 215 interventional studies indexed under Mucositis.
Browse Mucositis studies →Rowpar Pharmaceuticals, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive CloSYS Ultra Sensitive Rinse
Drug: Stabilized chlorine dioxide oral rinse
Subjects will receive oral rinse - no active ingredients
Other: Placebo
Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.
Patients received a rinse containing no active ingredients and periodontal basic therapy.
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
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
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
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.
| Milestone | Test - Stabilized Chlorine Dioxide Rinse | Placebo - Oral Rinse, no Active Ingredients |
|---|---|---|
| Started | 29 | 28 |
| Completed | 27 | 28 |
| Not completed | 2 | 0 |
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.
| mm | Test - Stabilized Chlorine Dioxide Rinse | Placebo - Oral Rinse, no Active Ingredients |
|---|---|---|
| Global Probing Depth | 2.37 ± 0.166 | 2.64 ± 0.130 |
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.
| score on a scale | Test - Stabilized Chlorine Dioxide Rinse | Placebo - Oral Rinse, no Active Ingredients |
|---|---|---|
| Global Plaque Score. | 1.57 ± 0.110 | 1.98 ± 0.110 |
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.
| score on a scale | Test - Stabilized Chlorine Dioxide Rinse | Placebo - Oral Rinse, no Active Ingredients |
|---|---|---|
| Modified Gingival Index (MGI) | 1.48 ± 0.025 | 1.52 ± 0.035 |
Collected over 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test - Stabilized Chlorine Dioxide Rinse | 0/29 (0%) | 0/29 (0%) | 3/29 (10.3%) |
| Placebo - Oral Rinse, no Active Ingredients | 0/28 (0%) | 0/28 (0%) | 1/28 (3.6%) |
| Event | Test - Stabilized Chlorine Dioxide Rinse | Placebo - Oral Rinse, no Active Ingredients |
|---|---|---|
| Scheduling IssuesSocial circumstances | 1/29 | 1/28 |
| Bitterness in the mouthProduct Issues | 1/29 | 0/28 |
| Unrelated injurySocial circumstances | 1/29 | 0/28 |
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.
| Age, Categorical(Participants) | Test - Stabilized Chlorine Dioxide Rinse | Placebo - Oral Rinse, no Active Ingredients | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 11 | 17 |
| >=65 years | 23 | 17 | 40 |
| Sex: Female, Male(Participants) | Test - Stabilized Chlorine Dioxide Rinse | Placebo - Oral Rinse, no Active Ingredients | Total |
|---|---|---|---|
| Female | 12 | 18 | 30 |
| Male | 17 | 10 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Test - Stabilized Chlorine Dioxide Rinse | Placebo - Oral Rinse, no Active Ingredients | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 26 | 26 | 52 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Test - Stabilized Chlorine Dioxide Rinse | Placebo - Oral Rinse, no Active Ingredients | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 1 | 4 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 25 | 22 | 47 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Jan 2020, 22 months.
Results were first posted in Apr 2022, 2 years 2 months after primary completion.
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Rowpar Pharmaceuticals, Inc.