Clinical trial NCT05805865
Conditions: Gingival Inflammation
Keywords: Gingival Index Plaque Index Dentifrice Toothpaste Tablets Consumer Satisfaction
Sponsor: Loma Linda University
Start date: 2023-01-03; Completion date: 2023-01-23
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objectives: To assess the change in gingival index (GI) and plaque index (PI) when comparing the use of toothpaste tablets to conventional toothpaste.

Methods: 40 participants were randomized into two groups: Colgate's toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (C). Both groups utilized their assigned dentifrice for 2 weeks. A pre and post-assessment measured the GI and PI index. A questionnaire on the use of the product was distributed.

Detailed description:

Arms: arm 1: Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. arm 2: Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes.
Interventions: intervention 1: Toothpaste Tablet intervention 2: Conventional Toothpaste
Intervention descriptions: intervention 1: Colgate Anywhere Toothpaste Tablets intervention 2: Colgate Cavity Protection

Protocol documents:
Prot_SAP_000.pdf: 
Page 1 of 12 
 
Study Title: Efficacy of Eco-Friendly Toothpaste Tablets versus Conventional Toothpaste using 
PI and GI Index 
 
NCT No: NCT05805865 
 
Date: 12/01/2022 


Page 2 of 12 
 
PROTOCOL TEMPLATE OUTLINE AND GUIDELINES FOR CLINICAL RESEARCH 
 
 
1. 
PROTOCOL INFORMATION 
 
Study Title: Efficacy of Eco-Friendly Toothpaste Tablets versus Conventional 
Toothpaste using PI and GI Index 
Funding Source:  Loma Linda School of Dentistry 
Investigation Product: Colgate “Cavity Protection” toothpaste and Colgate toothpaste 
tablets  
IND / IDE number: N/A 
Phase of Study: N/A 
Version Date of Protocol: October 5, 2022 
 
2. 
PRINCIPAL INVESTIGATOR’S INFORMATION 
 
PI Name, Title: So Ran Kwon, DDS, MS, PhD, MS 
Name & Address of Research Institution:  
       Loma Linda School of Dentistry 
       Prince Hall Rm# 4403 
       11092 Anderson St 
       Loma Linda, Ca 92350 
 
Phone #: (909) 558 – 5118 (ext. 55118) 
Fax #:  (909) 558- 0253 
Email Address: sorankwon@llu.edu  
 
3. 
STUDY PERSONNEL INFORMATION 
 
Amber Martinez, Senior Dental Hygiene student  
Jaclyn Im, Senior Dental Hygiene student 
Emili Bezman, Senior Dental Hygiene student 
Esther Lee, Senior Dental Hygiene student 
Dominic DeAnda, Senior Dental Hygiene student  
Rachel Ree, Senior Dental Hygiene student  
Shelly Withers, Dental hygiene faculty 
 
Phone #: 206-834-5765 
Email Address: ebezman@students.llu.edu 
 
4. 
STUDY INFORMATION 
 
Location(s) of Research Activity: Loma Linda School of Dentistry 
Expected Start/Stop Dates of Research: 11/01/2022 to 08/30/2023 
Special Time Sensitivities: N/A 
Type of Research: Minimal Risk 
Anticipated Enrollment number: 40 
Patient Population: 40 subjects 
 
 
 


Page 3 of 12 
 
5. 
OBJECTIVES AND PURPOSE 
 
Due to its travel-friendly size and eco-friendliness, toothpaste tablets have gained 
popularity among the green people. Green people are those who aim to achieve 
sustainability. Despite toothpaste tablets’ many merits, there is only scarce information 
on the efficacy, consumer satisfaction, cost, and benefits. Therefore, the purpose of our 
study is to evaluate the efficacy of toothpaste tablets when compared to conventional 
toothpaste in removing plaque. We aim to evaluate this by, measuring gingival index (GI) 
and the plaque index (PI) on subjects that have been either using the tabs or toothpaste.  
 
We hypothesize that there will be no statistically significant difference in GI and PI 
scores between the two groups. The results of the study will be highly significant as it 
will serve as a strong piece of evidence to recommend or not to recommend this newly 
developed product that has the potential to keep our planet safe from non-degradable 
plastic.  
 
6. 
STUDY DESIGN 
 
Background Information & Rationale  
 
Countless plastic toothpaste tubes are thrown out daily because conventional toothpaste is 
the prime tooth cleansing agent for millions around the world. Despite its ability to 
effectively tackle gum disease, malodor (bad breath), calculus, and dentin 
hypersensitivity, populations are not utilizing the whole tube as 10% still remains when 
discarded.6,7 Therefore, plastic alternatives such as Colgate’s Anywhere Toothpaste Tabs, 
DentTabs, Bite, and many other companies manufactured dissolving, chewable toothpaste 
in the form of small tablets. This favors sustainable consumerism at a slightly higher cost. 
Containing fewer ingredients than most toothpaste while packaged into reusable jars, 
toothpaste tablets’ purpose forces individuals to be eco-friendly while still demonstrating 
excellent oral hygiene care. In addition, previous research has shown toothpaste tablets to 
have only a negligible dentin abrasion depth of 0.02mm compared to conventional 
toothpaste’s 0.06mm loss.2  Regardless of its non-abrasive component and versatile size, 
the last several years prompted questions regarding tablets’ capability of plaque 
elimination. 
 
Plaque accumulates on tooth surfaces due to the presence of biofilm. Biofilm consists of 
bacterial microorganisms that start as translucent, unstructured film that can eventually 
transition into calcified hard tenacious stones inside the oral cavity.12 Due to its quick 
formation in a matter of 21 days, untouched biofilm left on tooth surfaces can ultimately 
lead to the development of dental caries and periodontal disease. 
  
In order to show the effectiveness of plaque removal between conventional toothpaste 
versus toothpaste tablets, two highly recognized indices will be used: gingival index (GI) 
and Turesky’s Modified plaque index (PI)–originally changed from Quigley Hein Index.  
 
 
 
 
 


Page 4 of 12 
 
Gingival Index (GI) was introduced by Loe and Silness in 1963. GI can be used in all 
teeth or selected teeth. The examination will be done by a blunt probe. The following teeth 
will be used, 
 
 
          The GI scores will indicate as follows, 
0: No inflammation. 
1: Mild inflammation, slight change in color, slight edema, no bleeding on probing. 
2: Moderate inflammation, moderate glazing, redness, bleeding on probing. 
3: Severe inflammation, marked redness and hypertrophy, ulceration, tendency to 
spontaneous bleeding.  
 
The GI index will be calculated as follows, 
 
GI Index= GI total scores/No of surfaces (N=18) 
 
GI Index Interpretation, 
 
0.1–1.0: Mild gingivitis  
1.1–2.0: Moderate gingivitis  
2.1–3.0: Severe gingivitis  
For measuring plaque accumulation, the Turesky Modified version contains a basis from 
0-5, while also distinguishing severity and location. The same six teeth will be used. 
The PI scores will indicate as follows, 
0: No plaque. 
1: Separate flecks of plaque at the cervical margin of the tooth. 
2: A thin continuous band of plaque at the cervical margin of the tooth. 
3: A band of plaque wider than 1 mm covering less than 1/3rd of the crown of the tooth. 
4: Plaque covering at least 1/3rd but less than 2/3rd of the crown of the tooth. 
5: Plaque covering 2/3rd or more of the crown of the tooth. 
 


Page 5 of 12 
 
Given the environmental advantages of toothpaste tabs, it is worth exploring the 
effectiveness of tabs following the action of daily brushing within a 2-week trial period.   
 
After measurements are recorded, comparison of the GI & PI results between tabs and 
conventional toothpaste will be assessed.   
 
 
a. Endpoints  
 
Primary endpoints  
GI and PI scores between the use of dental tablets and conventional toothpaste.  
 
Secondary endpoints  
Satisfaction on user-friendliness of both types of toothpastes. 
 
b. Overall study design 
 
A convenience sample of 40 participants will be randomized into two groups containing 20 
individuals each. Randomization will be performed by using a randomization table that is 
generated by the statistician. Selection of participants will concur to a written consent primarily 
based on voluntary agreement restricted only to a student consensus.  
Group A. Colgate Cavity Protection will be selected as the conventional toothpaste for the 
control group due to its low abrasivity8.  
Group B. Colgate Anywhere Toothpaste Tablets will be used as the prime cleansing agent for the 
experimental group.  
 
Subjects will be instructed to use their normal oral hygiene routine throughout a 2-week timeline. 
New toothbrushes will be used for both groups– Colgate Slim Soft Gliding Tips Toothbrush, 
Extra Soft, Compact Head.  
 
Group B will be instructed to use Colgate Anywhere toothpaste tablets where one tablet will be 
used for brushing. Subjects will gently chew on the tablet to dissolve it and will brush for two 
minutes at least twice a day. Any residual excess from the tablets are to be spit out. Group A will 
use Colgate Cavity Protection toothpaste and brush at least twice a day for two minutes. 
 
c. Study Procedures and Schedule  
 
Subjects will consent to participate. The examiner will then perform an oral examination to 
provide an evaluation of plaque and gingival indexes. Post 2 weeks, a final assessment will be 
given by the same examiner done in the exact order and technique as the baseline test. The teeth 
will be reevaluated with new numeric data, where the scores will be added then divided by the 
total site surfaces. At the end participants will receive a 10-item satisfaction survey. 
 
 
d. Alternative procedures à N/A 
 
e. Deception  à N/A  
 
f.  Investigational New Drug (IND)  à  N/A 
 


Page 6 of 12 
 
 
7. 
INCLUSION / EXCLUSION CRITERIA 
 
Inclusion criteria:  
 
1. Subjects are 18 years or older; 
2. Subjects who will comply with study protocol; 
3. Subjects who can read and understand the consent form; 
4. Subjects available during the study period; 
5. Subjects have more than 20 teeth. 
 
Exclusion criteria:  
 
 
 
     1. Subjects who are pregnant and/or nursing; 
                 2.Subjects under the age of 18. 
 
8. 
RECRUITMENT AND RETENTION 
 
          A flyer will be posted on LLUSD dental hygiene board. Please see attachment. 
 
 
9. 
INFORMED CONSENT PROCESS 
 
Informed consent will be obtained in accordance with the Declaration of Helsinki, ICH 
GCP, US Code of Federal Regulations for Protection of Human Subjects (21 CFR 
50.25[a,b], CFR 50.27, and CFR Part 56, Subpart A), the Health Insurance Portability and 
Accountability Act (HIPAA, if applicable), and local regulations. 
 
          Prior to conducting any study-related activities, written informed consent and the Health  
          Insurance Portability and Accountability Act (HIPAA) will be signed and dated by the 
          subject.  
 
The LLUSD East Wing Clinic will be used for the study. The reception desk will be used 
for student researchers to obtain the consent form from subjects that volunteer and are 
eligible. 
 
 
10. 
SCREENING 
 
           On arrival at the reception desk, subjects will be screened for the listed inclusion and  
           exclusion criteria.  
 
 
11. 
POTENTIAL RISKS  
 
There is minimal risk going through the clinical examination. However, there may be 
some jaw pain associated with prolonged mouth opening. Standard of care procedures for 
clinical oral examination will be followed under the supervision of a licensed dentist 
(including but not limited to proper PPE, infection control) and the process of assessment 
and survey will be explained during recruitment. 


Page 7 of 12 
 
 
 
 
          There is the possibility of a breach of confidentiality, this will be minimized by Subject  
          data will be stored in a locked suite, locked office, and locked cabinet. Data stored  
          electronically is only kept on secure LLU server. 
 
12. 
POTENTIAL BENEFIT(S) 
 
Potential benefits to subjects and society would be to provide that there is not a clinical or 
statistical difference in the efficacy of dental tablets versus conventional toothpaste. Providing 
data that presents no difference in using either tablets or toothpaste may incline the public to 
switch to an eco-friendlier dentifrice, thus reducing waste. Potential benefits outweigh the 
risks of this study due to the very low risk involved.  
 
 
13. 
SUBJECT WITHDRAWAL OR TERMINATON 
 
Reasons for withdrawal or termination: Subjects will have the freedom to withdraw at  
any time point of the study.  
 
Handling of subject withdrawals or termination: Records will be kept on subjects that  
choose to withdraw and the reason why. 
 
Premature termination or suspension of study: N/A 
 
        
14. 
COMPENSATION 
 
No compensation will be given to participants 
 
 
15. 
CONFIDENTIALITY AND PRIVACY 
 
There is the possibility of a breach of confidentiality, this will be minimized by Subject 
data will be stored in a locked suite, locked office, and locked cabinet. Data stored 
electronically is only kept on secure LLU server. 
 
16. 
DATA COLLECTION AND MANAGEMENT RESPONSIBLITIES 
 
 
Data Collection and Storage  
• Data will be collected on the data collection sheet. 
• Survey will be completed by the subjects on a hard copy. 
• Data will be entered electronically onto an excel spreadsheet. 
o Paper records will be locked in a secure location 
o Electronic records will be stored on a password-protected or 
encrypted computer as appropriate based on the sensitivity of data. 
• Consent forms will be stored in a locked suite, locked office, and locked 
cabinet. 


Page 8 of 12 
 
• Data will not be transferred outside of LLUH.  
 
Record Retention  
1. Records of data/samples generated in the course of this study will be kept for 
at least 6 years and then destroyed. Prior to destruction, data can be used for 
other IRB approved research. 
 
17. 
STATISTICAL ANALYSIS 
 
We hypothesize that there will be no statistically significant difference in GI and PI scores 
between the two groups. To test this hypothesis, we will use an independent sample t-test to 
compare the difference in GI and PI scores between the two groups. If it is determined that GI 
and/or PI are not normally distributed, we will proceed with testing our hypothesis with the 
Mann-Whitney U-test. This hypothesis will be tested at an alpha level of 0.05 and will be two-
sided. A sample size analysis was conducted and demonstrated that 20 samples per group 
were necessary to achieve 80% power to test this hypothesis at an alpha level of 0.05.  
 
18. 
DATA AND SAFETY MONITORING PLAN (DSMP)  
 
N/A 
 
 
19. 
LITERATURE REFERENCES 
 
1. Gängler, Peter et al. “In vitro effect of fluoride oral hygiene tablets on artificial caries 
lesion formation and remineralization in human enamel.” BMC oral health vol. 9 25. 2 
Oct. 2009, doi:10.1186/1472-6831-9-25   
 
2. 
Shaikh, Mohammed et al. “Micro computed tomography analysis of abrasivity of 
toothpaste tablets compared to conventional toothpaste.” American journal of dentistry vol. 34,5 
(2021): 235-239. 
 
3. 
Kraivaphan P, Amornchat C. Comparative clinical efficacy of three toothpastes in the 
control of supragingival calculus formation. Eur J Dent. 2017 Jan-Mar;11(1):94-98. doi: 
10.4103/ejd.ejd_279_16. PMID: 28435373; PMCID: PMC5379843. 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5379843/  
 
4. 
Chasma, Farida, and Gary Cousin. “Keeping Teeth Clean – but Not at the Environment’s 
Expense.” Faculty Dental Journal, vol. 12, no. 1, 2021, pp. 20–22., 
https://doi.org/10.1308/rcsfdj.2021.5. 
https://www.researchgate.net/publication/348155830_Keeping_teeth_clean_-
_but_not_at_the_environment's_expense  
 
5. 
 Moslehzadeh, Kaban. “Quigely Hein Index (modified). Malmo University. 27 Apr. 2016, 
https://www.mah.se/CAPP/Methods-and-Indices/Oral-Hygiene-Indices/Quigely-Hein-Index-
modified/  
6. 
Lippert F. An introduction to toothpaste - its purpose, history and ingredients. Monogr 
Oral Sci 2013; 23:1-14. 
 
7. 
300 million toothpaste tubes go to landfill. Br Dent J 2021; 230-390. 


Page 9 of 12 
 
 
8. 
Löe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J 
Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. PMID: 
5237684. 
https://aap.onlinelibrary.wiley.com/doi/abs/10.1902/jop.1967.38.6.610?sid=nlm%3Apubmed  
 
9. 
“Amazon.com : Colgate Anywhere Travel Toothpaste Tablets with Fluoride ...” Amazon, 
https://www.amazon.com/Colgate-Anywhere-Toothpaste-Anti-Cavity-
Refillable/dp/B08KQMC5MJ.   
10. 
“Cavity Protection Toothpaste: Colgate®.” Cavity Protection Toothpaste | Colgate®, 
https://www.colgate.com/en-us/products/toothpaste/cc-cavity-protection.  
 
11. 
Moslehzadeh, Kaban. “Quigely Hein Index (modified). Malmo University. 27 Apr. 2016, 
https://www.mah.se/CAPP/Methods-and-Indices/Oral-Hygiene-Indices/Quigely-Hein-Index-
modified/  
 
12. 
Wilkins, Esther M., et al. Clinical Practice of the Dental Hygienist. 12th ed., Wolters 
Kluwer, 2017, pp. 372, 400. 
 
13. 
Amazon.com : Colgate Slim Soft Gliding Tips Toothbrush, extra soft ... (n.d.). Retrieved 
August 30, 2022, from https://www.amazon.com/Colgate-Gliding-Toothbrush-Extra-
Compact/dp/B07NXDWX7S   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Page 10 of 12 
 
 
Schedule of Events 
 
 
 
VISIT 1 
(Day/Week/Month) 
VISIT 2 
(Day/Week/Month) 
Informed Consent 
X 
 
Baseline Oral Examination (GI & PI) 
X 
 
Distribution of Product 
X 
 
Post 2-Week Oral Examination (GI & PI) 
 
X 
Survey Distribution 
 
X 
Weight  
 
 
Vital Signs  
 
 
Oximetry 
 
 
Spirometry 
 
 
 


Page 11 of 12 
 
RESULTS 
Table 1. Summary of Gender and Age for Subjects Who Completed the Two-Week Clinical Study 
 
 
 
 
 
 
 
  
Number of Subjects  
  
Age 
Dentifrice 
Male 
Female 
Total 
  
Mean 
Range 
Sodium Fluoride Toothpaste1 
8 
12 
20 
  
25 
18-36 
Sodium Fluoride Toothpaste Tablet2 
6 
14 
20 
  
25 
19-30 
 
Table 2. Summary of the Baseline Loe-Silness Gingival Index Scores and Quigley-Hein Plaque Index Scores  
 
 
  
  
  
  
  
  
95% Confidence Interval 
Parameter 
Dentifrice 
N 
Baseline (Mean±SD) 
Mean Difference  
p-value 
Lower 
Upper 
Gingivitis 
Toothpaste Tablet 
20 
1.35±0.26 
-0.08 
0.47 
-0.19 
0.13 
  
Conventional Dentifrice 
20 
1.37±0.24 
  
  
  
  
Plaque 
Toothpaste Tablet 
20 
2.80±0.58 
0.06 
0.665 
-0.36 
0.38 
  
Conventional Dentifrice 
20 
2.78±0.46 
  
  
  
  
 
Table 3. Summary of the two-week Loe-Silness Gingival Index Scores and Quigley-Hein Plaque Index Scores 
 
 
  
  
  
  
  
  
95% Confidence Interval 
Parameter 
Dentifrice 
N 
Two-Week (Mean±SD) 
Mean Difference  
p-value 
Lower 
Upper 
Gingivitis 
Toothpaste Tablet 
20 
1.33±0.26 
-0.06 
0.37 
-0.167 
0.083 
  
Conventional Dentifrice 
20 
1.34±0.18 
  
  
  
  
Plaque 
Toothpaste Tablet 
20 
2.59±0.49 
0.08 
0.579 
-0.25 
0.417 
  
Conventional Dentifrice 
20 
2.56±0.48 
  
  
  
  
 
 
 
 
 
 


Page 12 of 12 
 
Table 4. Summary of Within Group Analysis  of Loe-Silness Gingival Index and Quigley-Hein Plaque Index Scores  
 
  
  
  
  
  
  
95% Confidence 
Interval 
Parameter 
Dentifrice 
N 
Mean Difference  
Percent Reduction 
p-value 
Lower 
Upper 
Gingivitis 
Toothpaste Tablet 
20 
-0.026 
1.9 
0.765 
-0.117 
0.064 
  
Conventional Dentifrice 
20 
-0.011 
0.8 
0.936 
-0.070 
0.048 
Plaque 
Toothpaste Tablet 
20 
-0.224 
8.0 
0.017 
-0.453 
0.005 
  
Conventional Dentifrice 
20 
-0.218 
7.8 
0.035 
-0.391 
-0.045