An interventional study of Enzyme toothpaste and active salt toothpaste in Gingivitis; Chronic, Gingivitis and Periodontal Diseases and Dental Plaque, sponsored by Uttar Pradesh University of medical sciences. Completed at 1 site in India. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Uttar Pradesh University of medical sciences · Not applicable, Interventional, and Treatment
Dental plaque is a major etiological factor in the development of gingivitis. Mechanical plaque control through toothbrushing is essential for maintaining oral hygiene, while toothpaste formulations containing active ingredients may provide additional benefits in controlling plaque accumulation and gingival inflammation. Enzymatic toothpaste containing the lactoperoxidase system and salt-containing toothpaste incorporating sodium chloride and sodium bicarbonate have been investigated for their potential effects on plaque control and gingival health.
This randomized, prospective, double-blind, parallel-group clinical study evaluated and compared the efficacy of enzymatic toothpaste, active salt toothpaste, and standard fluoridated toothpaste in reducing dental plaque and gingival inflammation following non-surgical periodontal therapy (NSPT).
The study was conducted in the Department of Periodontology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh, India, from July 2021 to December 2022. The study protocol received approval from the Institutional Ethics Committee of Uttar Pradesh University of Medical Sciences (approval number: 222/2020-21). Written informed consent was obtained from all participants before study procedures.
A total of 93 eligible participants with mild to moderate gingivitis were enrolled and randomly allocated to three groups. All participants initially received non-surgical periodontal therapy and used standard fluoridated toothpaste for a four-week pretreatment period. Following the pretreatment period, baseline clinical assessments were performed, and participants received the toothpaste assigned to the respective study group.
Group I received enzymatic toothpaste (Curaprox Enzycal 950), containing amyloglucosidase, glucose oxidase, lactoperoxidase, and potassium thiocyanate. Group II received active salt toothpaste (Colgate Active Salt), containing sodium chloride and sodium bicarbonate. Group III received standard fluoridated toothpaste (Colgate Strong Teeth), containing calcium carbonate and sodium monofluorophosphate.
Participants were instructed to brush their teeth for two minutes twice daily using the allocated toothpaste for 12 weeks. The use of mouthwashes, interdental aids, and other antiplaque products was restricted during the pretreatment and intervention periods.
Clinical assessments were performed at baseline, following the four-week pretreatment period, and after the 12-week intervention period, as specified in the study protocol. The clinical parameters included the Turesky-Gilmore-Glickman modification of the Quigley-Hein Plaque Index (TQHPI), the Gingival Index (GI), and probing pocket depth (PPD).
The collected data were analyzed using SPSS software, version 20.0. Within-group and between-group comparisons were performed using appropriate parametric and non-parametric statistical tests. Statistical significance was set at p less than 0.05.
Introduction A diverse microbiota of more than 700 species of bacteria and other microorganisms inhabits the oral cavity. These are present in an organized form as dental plaque or biofilm. These commensal microorganisms live in harmony with the host and perform a number of important functions, such as preventing the colonization of pathogenic microorganisms. However, sometimes this commensalism relationship might collapse, leading to conditions including gingivitis, periodontitis and dental caries. This could be prevented by proper plaque control. Plaque control involves the utilization of chemical agents and mechanical techniques. Mechanical plaque control like toothbrushing is the key for maintaining oral hygiene at personal level. Despite the effectiveness of adequate mechanical removal of plaque having been demonstrated, only 11-51% of people clean their teeth properly . Chemical plaque control agents like toothpastes and mouthwashes are therefore required as an adjunct to mechanical plaque control. Triclosan, herbs, enzymes, chlorhexidine, metal ions, salt etc are incorporated in the toothpaste as an active agent.
In last decade, an in-vitro study on enzymatic toothpaste (active ingredients lactoperoxidase, amyloglucosidase, and glucose oxidase) has shown to strengthen the oral cavity's natural antibacterial system by raising salivary levels of hydrogen peroxide, lysozyme, and hypothiocyanite while also reducing the survival of oral bacterial biofilms. The similar enzyme containing toothpaste in a sequencing study on dental plaque samples has shown significant shift in the ecology of microbiome (at species level). There was increase in 12 taxa of periodontal health promoting microbes like Neisseria spp. and decrease in 10 taxa of pathogenic microbe like Treponema spp. Several clinical studies have shown encouraging results of the enzymatic toothpaste in reducing dental plaque and gingivitis. , , Another important active ingredient that is known for its effect as an anti-inflammatory action is salt (including sodium chloride and sodium bicarbonate). The recent studies on the salt have shown that rinsing with NaCl solution can stimulate gingival fibroblast migration and thereby enhances wound healing. A randomized clinical trial evaluating the effect of sodium bicarbonate containing toothpaste on mild to moderate gingivitis patient has shown to improve the gingival health and bleeding. Systemic review on salt containing toothpaste concluded promising result obtained on controlling plaque and reduction in bleeding score.
The objective of the current study was to evaluate and compare the efficacy of enzymatic toothpaste (lactoperoxidase, amyloglucosidase, and glucose oxidase) and active salt toothpaste (sodium bicarbonate and sodium chloride) in the reduction of dental plaque and gingivitis in North Indian population.
Review of literature Dental plaque is defined clinically as a structured resilient, yellow greyish substance that adheres tenaciously to the intraoral hard surfaces, including removal and fixed restorations.
Chemotherapeutic agents could also affect gingivitis directly if they possessed anti-inflammatory or prostaglandin synthetase inhibitory activity (Goodson). As a consequence many antimicrobial compounds have been added in the toothpaste or as mouthrinses with the aim of preventing or reducing plaque.
Enzymes and salt are few of the active ingredients that are added in the toothpaste. Previous studies have shown that the inclusion of enzymes in the mouthrinses and dentifrices reduce plaque and gingivitis. The enzymes that are most effective clinically have, as their active ingredients, Amyloglucosidase, Glucoseoxidase and Lactoperoxidase.
Hugoson A et al. conducted a study to test the efficiency of Lactoperoxidase in the prevention of plaque accumulation, gingivitis and dental caries. They used twenty-two dental students. The individuals in the test group rinsed with 10ml of of a test solution containing Amyloglucosidase, Glucoseoxidase 3 times a day. The controls rinsed with a placebo solution. They were refrained from the daily oral hygiene routine. At the end of the experimental period there were highly significant differences in caries distribution between the test and control groups, with a more pronounced aggravation of the caries lesions in the control group compared with the test group.
Afseth J and Rolla G did a study to test the efficiency of enzymatic toothpaste over SnF2 containing toothpaste. They found that the enzymatic toothpaste did not reduce the acidogenicity of dental plaque in vivo neither did it reduce plaque formation in a test panel. A toothpaste containing SnF2 showed measurable effect in both respects.
Salt (sodium chloride and sodium bicarbonate) are added as an active ingredient in the toothpaste. To find out the mechanism of salt on gingival healing, Nam Cong-Nhat Huynh et al.16 did a study and found out that rinsing with 1.8% NaCl significantly up regulate the expression of type-I collagen and fibronectin. They found that a high NaCl concentration especially with long term exposure causes DNA damage and inhibits its repair This may lead to apoptosis or may affect cellular survival and their function both in cell culture and in vivo.
Material and method
This randomized, prospective, double-blind, parallel-group clinical study evaluated and compared the efficacy of enzymatic toothpaste, active salt toothpaste, and standard fluoridated toothpaste in reducing dental plaque and gingival inflammation following non-surgical periodontal therapy (NSPT).
The study was conducted in the Department of Periodontology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh, India, from July 2021 to December 2022. The study protocol received approval from the Institutional Ethics Committee of Uttar Pradesh University of Medical Sciences (approval number: 222/2020-21). Written informed consent was obtained from all participants before study procedures.
A total of 93 eligible participants with mild to moderate gingivitis were enrolled and randomly allocated to three groups. All participants initially received non-surgical periodontal therapy and used standard fluoridated toothpaste for a four-week pretreatment period. Following the pretreatment period, baseline clinical assessments were performed, and participants received the toothpaste assigned to the respective study group.
Statistical analysis A Microsoft Excel spreadsheet was used to enter the data, and any discrepancies were looked at. Data analyses were done using SPSS version 20.0 and non parametric test (Wilcoxon signed rank test, Kruskal-wallis test, Mann-Whitney Test) and parametric test (Paired t-test, ANOVA, Turkey's post hoc analysis) used for comparing means in different group of individual before and after interval. Tables and figures were used to display the summarized data. Level of statistical significance was set at p-value less than 0.05, confidence level at 95% and power at 80%
609 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's enrollment of 93 is above the median of 63 across 494 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →This is the only study on the registry with Uttar Pradesh University of medical sciences as lead sponsor.
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the patients received allocated toothpaste i.e., Active salt toothtpaste and were asked to brush for 2 minutes, twice a day for a period of 12 weeks.
Drug: active salt toothpaste
the patients received allocated toothpaste i.e., Standard Fluoridated toothpaste and were asked to brush for 2 minutes, twice a day for a period of 12 weeks.
Drug: standard fluoridated toothpaste
the patients received allocated toothpaste, i.e., Enzymatic Toothpaste and were asked to brush for 2 minutes, twice a day for a period of 12 weeks
Drug: Enzyme toothpaste
4 weeks After non surgical periodontal therapy the patient randomly allocated to the groups. the patient of group I received enzymatic toothpoaste and were asked to brush for 2 minutes, twice a day for a period of 12 weeks after evaluating the baseline clinical parameters. During the period, patients were asked not to use mouthwash, interdental aids or any other antiplaque products. After 12 weeks of use of allocated toothpaste, patients returned to the department for final clinical assessment. The data obtained were statistically analysed.
Also known as: enzyme containing toothpaste and active salt toothpaste, standard fluoridated toothpaste
4 weeks After non surgical periodontal therapy the patient randomly allocated to the groups. the patient of group II received active salt toothpaste and were asked to brush for 2 minutes, twice a day for a period of 12 weeks after evaluating the baseline clinical parameters. During the period, patients were asked not to use mouthwash, interdental aids or any other antiplaque products. After 12 weeks of use of allocated toothpaste, patients returned to the department for final clinical assessment. The data obtained were statistically analysed.
4 weeks After non surgical periodontal therapy the patient randomly allocated to the groups. the patient of group III received standard fluoridated toothpaste and were asked to brush for 2 minutes, twice a day for a period of 12 weeks after evaluating the baseline clinical parameters. During the period, patients were asked not to use mouthwash, interdental aids or any other antiplaque products. After 12 weeks of use of allocated toothpaste, patients returned to the department for final clinical assessment. The data obtained were statistically analysed.
Gingival Index
Gingival index was developed by Loe H and Sillness P in 1963, solely on the purpose of purpose of assessing the severity of gingivitis and its location in 4 possible areas by examining only the qualitative changes of the gingival soft tissue. Instrument used- mouth mirror, periodontal probe Interpretation- Mild gingivitis- 0.1-1.0, Moderate gingivitis- 1.1- 2.0, Severe gingivitis- 2.1-3.0 Minimum score 0, maximum score 3. Higher score means worse outcome
Time frame: 12 weeks
Plaque Index
Quigley-Hein has given the plaque index in 1962 that focused on plaque measurement on the gingival third of tooth surface only on the facial surfaces of anterior teeth. Quigley-Hein plaque index was modified by Turesky, Gilmore and Glickman in 1970. Plaque is assessed on the labial/buccal and lingual surfaces of all the teeth after using a disclosing agent (Quigley-Hein used basic fuchsin). Instrument used- Mouth mirror, Disclosing agent Interpretation: Low: 0-1, High: 2 or more Minimum score 0, maximum score 5. higher score means worse outcome
Time frame: 12 weeks
Probing pocket depth
Probing depth measured from gingival margin to the base of the periodontal pocket using UNC-15 periodontal probe (Hu-friedy 6, Mfd.Co., LLC, Rockwell, Chicago, USA). Minimum score 0, maximum score 3. higher score means worse outcome
Time frame: 12 weeks
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Plan to share: No — Patient identifiers will not be disclosed including ipd number
Ran from Jul 2021 to primary completion in Dec 2022, 17 months.
Of 203 non-industry interventional studies with no phase under Gingivitis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 19. This study's 17 months is above that.
Counting every sponsor, half of 255 studies reached it within 7 months; a quarter within 3 and three quarters within 16.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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