AzTrials
AzTrials

Gingivitis; ChronicEnzyme T/PNCT07880483

Comparision of Enzymatic and Active Salt Toothpaste

A study testing Enzyme toothpaste, active salt toothpaste and standard fluoridated toothpaste in people with Gingivitis; Chronic and Gingivitis and Periodontal Diseases, run by Uttar Pradesh University of medical sciences at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
What is being tested?
Enzyme toothpaste, active salt toothpaste and standard fluoridated toothpaste
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
1 siteIndia
Study dates
1 Jul 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects with mild to moderate gingivitis
  • Systemically healthy patients
  • Subjects with less than 20 permanent teeth remaining.

Who cannot join

  • Smoker
  • Pregnant or lactating female
  • Patients who have undergone non-surgical periodontal therapy in last 6 months.
  • Subjects who have received any antibiotic and anti-inflammatory therapy within three months.
  • Patients using enzymatic and active salt toothpaste in the last 6 months.
  • Not good dexterity

Trial locations and contacts

1 site in 1 country.

India1 site
  • Uttar Pradesh University of Medical Sciences

    Etāwah, Uttar Pradesh, 206130

Other trials in India

About this study

Official title: Comparative Evaluation of Efficiency of Enzymatic Toothpaste and Active Salt Toothpaste in the Reduction of Dental Plaque and Gingivitis

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).

Read more

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.

Read the detailed description

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%

Being tested
Enzyme toothpaste, active salt toothpaste, standard fluoridated toothpaste
Keywords
Comparative study, Toothpaste, Lactoperoxidase system
Medical subject headings
Gingivitis, Bronchiolitis Obliterans Syndrome, Periodontal Diseases, Dental Plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enzyme toothpasteDrug

    Also called 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 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.

  • active salt toothpasteDrug

    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.

  • standard fluoridated toothpasteDrug

    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.

Study groups in NCT07880483
Study groupRoleWhat they receive
Group IIExperimentalthe 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.
Receives: Drug: active salt toothpaste
Group IIIPlacebo comparatorthe 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.
Receives: Drug: standard fluoridated toothpaste
Group IExperimentalthe 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
Receives: Drug: Enzyme toothpaste

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks

  2. 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

    Measured: 12 weeks

Secondary outcomes (1)
  1. 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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2026
  2. Study start1 Jul 2021
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07880483
Sponsor's protocol ID
222/2020-21
Other IDs
222/2020-21
Acronym
Enzyme T/P
Status last verified
Oct 2026
First submitted
6 Oct 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Patient identifiers will not be disclosed including ipd number

Publications

  • Sanz M, Serrano J, Iniesta M, Santa Cruz I, Herrera D. Antiplaque and antigingivitis toothpastes. Monogr Oral Sci. 2013;23:27-44. doi: 10.1159/000350465. Epub 2013 Jun 28.

    PubMed 23817058
  • Bowen WH. Nature of plaque. Oral Sci Rev. 1976;9:3-21. No abstract available.

    PubMed 9613
  • Deo PN, Deshmukh R. Oral microbiome: Unveiling the fundamentals. J Oral Maxillofac Pathol. 2019 Jan-Apr;23(1):122-128. doi: 10.4103/jomfp.JOMFP_304_18.

    PubMed 31110428
  • Barnett ML. The rationale for the daily use of an antimicrobial mouthrinse. J Am Dent Assoc. 2006 Nov;137 Suppl:16S-21S. doi: 10.14219/jada.archive.2006.0408.

    PubMed 17035671

Questions about this trial

What is this clinical trial studying?

A study testing Enzyme toothpaste, active salt toothpaste and standard fluoridated toothpaste in people with Gingivitis; Chronic and Gingivitis and Periodontal Diseases, run by Uttar Pradesh University of medical sciences at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gingival Index (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07880483, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in