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Completed NCT07880483

Comparision of Enzymatic and Active Salt Toothpaste

Conditions: Gingivitis; Chronic, Gingivitis and Periodontal Diseases, Dental Plaque

Sex: All
Ages: 20 Years – 50 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 93
Sponsor: Uttar Pradesh University of medical sciences

Location: Uttar Pradesh University of Medical Sciences Etāwah Uttar Pradesh

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 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.

Eligibility Criteria

Inclusion Criteria: * aged 20-50 years with mild to moderate gingivitis (gingival index score ranges between 1 and 2.0), systemically healthy and have a minimum of 20 permanent teeth. Exclusion Criteria: * Smokers, pregnant or lactating females, patients who have undergone non-surgical periodontal therapy (NSPT) in the last 6 months or received any antibiotic and anti-inflammatory therapy within three months or patients using enzymatic and active salt toothpaste in the last 6 months were excluded.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07880483). StuddyBuddy aggregates publicly available trial information.