search
Back to results

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

Primary Purpose

Chronic Gingivitis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Cuminum Cyminum
herbal Mouthwash
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Gingivitis focused on measuring Mouthwash, chlorhexidine, stain

Eligibility Criteria

23 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cuminum cyminum mouthwash

herbal mouthwash

Arm Description

cuminum cyminum mouthwash in chronic gingivitis patients

herbal mouthwash in chronic gingivitis patients

Outcomes

Primary Outcome Measures

PLAQUE INDEX
PLAQUE INDEX: Turesky-Gilmore-Glickman Modification of Quigley Hein 1962
Gingival Index
Gingival Index: Loe H ans Silness 1963
Bleeding on probing
Bleeding on probing: Muhlemann HR and Son 1971

Secondary Outcome Measures

Full Information

First Posted
February 9, 2021
Last Updated
February 22, 2021
Sponsor
Maharishi Markendeswar University (Deemed to be University)
search

1. Study Identification

Unique Protocol Identification Number
NCT04767269
Brief Title
Efficacy of Cuminum Cyminum Herbal =Preparation in Inhibition of Plaque and Gingivitis.
Official Title
Efficacy of Cuminum Cyminum Herbal Preparation in Inhibition of Plaque and Gingivitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi Markendeswar University (Deemed to be University)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
To evaluate and compare the efficacy of 0.2% cuminum cyminum herbal preparation against 0.2% chlorhexidine by various clinical parameters i.e. plaque index, gingival index and sulcus bleeding index.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Gingivitis
Keywords
Mouthwash, chlorhexidine, stain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Group phase A Group phase B Group phase C
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cuminum cyminum mouthwash
Arm Type
Experimental
Arm Description
cuminum cyminum mouthwash in chronic gingivitis patients
Arm Title
herbal mouthwash
Arm Type
Active Comparator
Arm Description
herbal mouthwash in chronic gingivitis patients
Intervention Type
Drug
Intervention Name(s)
Cuminum Cyminum
Other Intervention Name(s)
Cuminum Cyminum mouthwash
Intervention Description
Cuminum Cyminum mouthwash in chronic gingivitis patients
Intervention Type
Drug
Intervention Name(s)
herbal Mouthwash
Other Intervention Name(s)
herbal mouthwash in chronic gingivitis patients
Intervention Description
herbal mouthwash in chronic gingivitis patients
Primary Outcome Measure Information:
Title
PLAQUE INDEX
Description
PLAQUE INDEX: Turesky-Gilmore-Glickman Modification of Quigley Hein 1962
Time Frame
changes from baseline to 8 days
Title
Gingival Index
Description
Gingival Index: Loe H ans Silness 1963
Time Frame
changes from baseline to 8 days
Title
Bleeding on probing
Description
Bleeding on probing: Muhlemann HR and Son 1971
Time Frame
changes from baseline to 8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: volunteers with minimum 20 natural teeth without restoration. cooperative motivated and committed to participate in the trial period. Exclusion Criteria: Antibiotic or anti-inflammatory therapy in previous month. Any known allergy/ hypersensitivity to any product used in trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
surinder sachdeva, M.D.S.
Organizational Affiliation
PROFESSOR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontology, M.M. College of Dental Sciences and Research.
City
Ambāla
State/Province
Haryana
ZIP/Postal Code
133207
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16451766
Citation
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.
Results Reference
background
PubMed Identifier
19089066
Citation
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.
Results Reference
background
PubMed Identifier
20809647
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs