A Clinical Trial to Assess Tooth Sensitivity Associated with Sensitive Whitening Strips

CLINICAL STUDY SYNOPSIS

A Clinical Trial to Assess Tooth Sensitivity Associated with Sensitive Whitening Strips

 

62 Adults enrolled

0 Adverse events

0.00 Clinician Schiff score (all visits)

p = 0.10 No significant difference vs. placebo

To evaluate the daily application of sensitive whitening strips to the maxillary teeth over a two-week period on the development of tooth sensitivity, as compared with a negative control (placebo).

 

This single-center, double-blind, randomized, placebo-controlled clinical study enrolled 62 adult subjects who were randomized into two groups. Group A received the GuruNanda sensitive whitening strips, while Group B used an identical-looking placebo strip. Both groups applied their assigned product once daily for two weeks and were assessed at three time points — Baseline, Week 1, and Week 2.

 

Sensitivity was measured using three standardized methods: the Schiff Cold Air Sensitivity Scale (0–3) via evaporative air-blast testing, tactile sensitivity testing via a calibrated periodontal probe, and subject-reported sensitivity on a Visual Analog Scale (VAS, 0–10). Subjects also maintained a daily sensitivity diary throughout the 14-day study period. All assessments were performed by the same California-licensed dental examiner. Oral soft tissue examinations were conducted at every visit. Statistical analysis of diary data used the Mann-Whitney U Test for between-group comparisons.

 

Group	Product	Subjects	Description
Group A	GuruNanda 2% H₂O₂ Whitening Strip	31 subjects	Active product applied once daily for 2 weeks
Group B	Placebo Strip (identical appearance)	31 subjects	Placebo applied once daily for 2 weeks

 

1. Clinician-Assessed Sensitivity (Schiff Cold Air Sensitivity Scale)

Both groups began the study with mean Schiff scores of 0.00. At Week 1 and Week 2, scores remained at 0.00 in both groups across all three clinician-administered measures (Schiff scale, tactile threshold, and VAS). No clinically meaningful sensitivity was recorded at any time point.

 

Assessment	Group	Baseline	Week 1	Week 2
Schiff Score (0–3)	Arm 1 (Product A)	0	0	0
Schiff Score (0–3)	Arm 2 (Product B)	0	0	0
Tactile Threshold (g)	Arm 1 (Product A)	0	0	0
Tactile Threshold (g)	Arm 2 (Product B)	0	0	0
VAS Score (0–10)	Arm 1 (Product A)	0	0	0
VAS Score (0–10)	Arm 2 (Product B)	0	0	0

 

Figure 1. Mean Schiff Cold Air Sensitivity Scores by visit — both groups remained at 0.00 throughout the study.

 

2. Subject-Reported Diary Sensitivity

Mean diary sensitivity scores were low in both groups throughout the study. Group A recorded an overall mean diary score of 0.09 (out of 2.0), with a Week 1 mean of 0.11 declining to 0.06 in Week 2. Group B recorded an overall mean of 0.05, with a Week 1 mean of 0.06 declining to 0.03 in Week 2. The between-group difference was not statistically significant (Mann-Whitney U = 530.0, p = 0.10). Scores trended downward in both groups from Week 1 to Week 2, indicating no cumulative sensitization with continued daily use.

 

Figure 2. Mean subject-reported diary sensitivity scores by study period. Both groups remained well below the midpoint of the scale throughout.

3. Sensitivity Category Distribution (Subject-Reported)

Of subjects in Group A, 69% reported no sensitivity at any point during the study, 27.6% reported mild sensitivity on at least one day, and 3.4% (one subject) reported moderate sensitivity on at least one day. In Group B, 87.1% reported no sensitivity at any point and 12.9% reported mild sensitivity. No subject in either group reported severe sensitivity (score = 3) at any time point.

 

Figure 4. Sensitivity category distribution across all 14 diary days. The majority of subjects in both groups reported no sensitivity throughout the study.

 

4. Sensitivity Summary Table

Measure	Group A – Whitening Strip (n=31)	Group B – Placebo (n=31)
Schiff score – Baseline	0.00	0.00
Schiff score – Week 1	0.00	0.00
Schiff score – Week 2	0.00	0.00*
Subjects with any diary sensitivity	9 (31.0%)	4 (12.9%)
Subjects with mild sensitivity only	8 (27.6%)	4 (12.9%)
Subjects with moderate sensitivity	1 (3.4%)	0 (0.0%)
Overall mean diary score (SD)	0.09 (0.17)	0.05 (0.18)
Week 1 mean diary score	0.11	0.06
Week 2 mean diary score	0.06	0.03
Mann-Whitney U (p-value)	—	U=530.0, p=0.10

 

*One subject (EXP 051) in Group B recorded Schiff scores of 1 on teeth #8 and #9 at Week 2 only. This was assessed as not attributable to the investigational product, as the subject was in the placebo arm.

 

5. Oral Soft Tissue Safety

All oral soft tissue sites — including the gingiva, labial and buccal mucosa, palate, tongue, floor of the mouth, and oropharynx — were assessed as 100% normal in both groups at every clinic visit (Baseline, Week 1, Week 2). No product-related abnormalities were observed at any point during the study.

 

Adverse Events No adverse events were reported or recorded in either group throughout the entire study period.

 

The GuruNanda sensitive whitening strips were found to be safe and well tolerated over a two-week period of daily use. Clinician-assessed sensitivity scores — measured by the Schiff Cold Air Sensitivity Scale, tactile threshold testing, and Visual Analog Scale — were zero across both the whitening strip and placebo groups at every clinic visit, with no sensitivity detected by the examining dentist in either group at any time point.

Subject-reported diary scores were low in both groups throughout the study, and the difference between the two groups was not statistically significant (p = 0.10), meaning the whitening strip group experienced a level of day-to-day sensitivity that was statistically indistinguishable from that of the placebo group. Sensitivity scores also trended downward from Week 1 to Week 2, confirming that continued daily use did not lead to any accumulation of sensitivity over time.

All oral soft tissues remained 100% healthy throughout the study, and no adverse events were recorded in either group. Taken together, these findings demonstrate that the GuruNanda sensitive whitening strips are as well tolerated as a placebo and supports its safety for daily use over a two-week whitening regimen.