Trial Outcomes & Findings for The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Per-implant Mucositis (NCT NCT04838054)

Last Updated: 2022-04-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

57 participants

Primary outcome timeframe

90 days

Results posted on

2022-04-14

Participant Flow

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.

No event occurred before participant enrollment.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	29	28
Overall Study COMPLETED	27	28
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Per-implant Mucositis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test - Stabilized Chlorine Dioxide Rinse n=29 Participants Subjects will receive CloSYS Ultra Sensitive Rinse Stabilized chlorine dioxide oral rinse: Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.	Placebo - Oral Rinse, no Active Ingredients n=28 Participants Subjects will receive oral rinse - no active ingredients Placebo: Patients received a rinse containing no active ingredients and periodontal basic therapy.	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test - Stabilized Chlorine Dioxide Rinse n=864 Teeth Subjects will receive CloSYS Ultra Sensitive Rinse Stabilized chlorine dioxide oral rinse: Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.	Placebo - Oral Rinse, no Active Ingredients n=896 Teeth Subjects will receive oral rinse - no active ingredients Placebo: Patients received a rinse containing no active ingredients and periodontal basic therapy.
Global Probing Depth	2.37 mm Standard Error 0.166	2.64 mm Standard Error 0.130

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test - Stabilized Chlorine Dioxide Rinse n=864 Number of Teeth Subjects will receive CloSYS Ultra Sensitive Rinse Stabilized chlorine dioxide oral rinse: Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.	Placebo - Oral Rinse, no Active Ingredients n=896 Number of Teeth Subjects will receive oral rinse - no active ingredients Placebo: Patients received a rinse containing no active ingredients and periodontal basic therapy.
Global Plaque Score.	1.57 score on a scale Standard Error 0.110	1.98 score on a scale Standard Error 0.110

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test - Stabilized Chlorine Dioxide Rinse n=864 Number of Teeth Subjects will receive CloSYS Ultra Sensitive Rinse Stabilized chlorine dioxide oral rinse: Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.	Placebo - Oral Rinse, no Active Ingredients n=896 Number of Teeth Subjects will receive oral rinse - no active ingredients Placebo: Patients received a rinse containing no active ingredients and periodontal basic therapy.
Modified Gingival Index (MGI)	1.48 score on a scale Standard Error 0.025	1.52 score on a scale Standard Error 0.035

Adverse Events

Test - Stabilized Chlorine Dioxide Rinse

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo - Oral Rinse, no Active Ingredients

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Test - Stabilized Chlorine Dioxide Rinse n=29 participants at risk Subjects will receive CloSYS Ultra Sensitive Rinse Stabilized chlorine dioxide oral rinse: Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.	Placebo - Oral Rinse, no Active Ingredients n=28 participants at risk Subjects will receive oral rinse - no active ingredients Placebo: Patients received a rinse containing no active ingredients and periodontal basic therapy.
Product Issues Bitterness in the mouth	3.4% 1/29 • Number of events 1 • 90 days	0.00% 0/28 • 90 days
Social circumstances Unrelated injury	3.4% 1/29 • Number of events 1 • 90 days	0.00% 0/28 • 90 days
Social circumstances Scheduling Issues	3.4% 1/29 • Number of events 1 • 90 days	3.6% 1/28 • Number of events 1 • 90 days

Additional Information

Srinivas Rao Myneni Venkatasatya, DDS, PhD

Stony Brook University

Phone: 631-632-8739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place