Efficacy of Cuminum Cyminum Herbal =Preparation in Inhibition of Plaque and Gingivitis.

NCT04767269 | Completed Phase 2 DMC

• 1 other identifier: MaharishiMu2012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Present work was to investigate the possible efficacy of 0.2% cuminum cyminum herbal preparation as an antiplaque and antigingivitis agent when compared with chlorhexidine.

Conditions

Chronic Gingivitis

Keywords

Mouthwash; chlorhexidine; stain

Outcome Measures

Primary Outcomes (3)

• PLAQUE INDEX

  PLAQUE INDEX: Turesky-Gilmore-Glickman Modification of Quigley Hein 1962

  changes from baseline to 8 days

• Gingival Index

  Gingival Index: Loe H ans Silness 1963

  changes from baseline to 8 days

• Bleeding on probing

  Bleeding on probing: Muhlemann HR and Son 1971

  changes from baseline to 8 days

Study Arms (2)

cuminum cyminum mouthwash

EXPERIMENTAL

cuminum cyminum mouthwash in chronic gingivitis patients

Drug: Cuminum Cyminum

herbal mouthwash

ACTIVE COMPARATOR

herbal mouthwash in chronic gingivitis patients

Drug: herbal Mouthwash

Interventions

Cuminum Cyminum DRUG

Cuminum Cyminum mouthwash in chronic gingivitis patients

Also known as: Cuminum Cyminum mouthwash

cuminum cyminum mouthwash

herbal Mouthwash DRUG

herbal mouthwash in chronic gingivitis patients

Also known as: herbal mouthwash in chronic gingivitis patients

herbal mouthwash

Eligibility Criteria

• Age: 23 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• volunteers with minimum 20 natural teeth without restoration.
• cooperative
• motivated and committed to participate in the trial period.

You may not qualify if:

• Antibiotic or anti-inflammatory therapy in previous month.
• Any known allergy/ hypersensitivity to any product used in trial.

Sponsors & Collaborators

• Maharishi Markendeswar University (Deemed to be University): lead

Study Sites (1)

Department of Periodontology, M.M. College of Dental Sciences and Research.

Ambāla, Haryana, 133207, India

Location

Related Publications (3)

• Southern EN, McCombs GB, Tolle SL, Marinak K. The comparative effects of 0.12% chlorhexidine and herbal oral rinse on dental plaque-induced gingivitis. J Dent Hyg. 2006 Winter;80(1):12. Epub 2006 Jan 1.

  PMID: 16451766 BACKGROUND

• Salgado AD, Maia JL, Pereira SL, de Lemos TL, Mota OM. Antiplaque and antigingivitis effects of a gel containing Punica granatum Linn extract: a double-blind clinical study in humans. J Appl Oral Sci. 2006 Jun;14(3):162-6. doi: 10.1590/s1678-77572006000300003.

  PMID: 19089066 BACKGROUND

• Bettaieb I, Bourgou S, Wannes WA, Hamrouni I, Limam F, Marzouk B. Essential oils, phenolics, and antioxidant activities of different parts of cumin (Cuminum cyminum L.). J Agric Food Chem. 2010 Oct 13;58(19):10410-8. doi: 10.1021/jf102248j.

  PMID: 20809647 BACKGROUND

Study Officials

• surinder sachdeva, M.D.S.

  PROFESSOR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1. Group phase A 2. Group phase B 3. Group phase C

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 23, 2021
• Study Start: January 1, 2019
• Primary Completion: January 15, 2021
• Study Completion: January 31, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)