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Clinical Trials/CTRI/2024/04/066218
CTRI/2024/04/066218Not yet recruitingPhase 2

Comparative evaluation of efficacy of herbal toothpaste tablets over standard toothpaste in reduction of plaque and gingivitis- A randomized controlled clinical trial

Dr. Haritha Avula1 site in 1 country28 target enrollmentStarted: May 1, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
28
Locations
1
Primary Endpoint
1. Plaque Index (PI): Quigley Hein with Turesky modification

Study Overview

Brief Summary

Gingivitis is a non- specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Regular oral hygiene practices could significantly reduce plaque accumulation and gingival inflammation. Toothpaste is the most widely utilized and an effective oral hygiene aid. Toothpaste tablets are a relatively new form of toothpaste that can be a viable alternative to conventional dentifrice.

Tablets are more environmentally friendly in comparison to toothpaste. Tablets are a dry formulation containing all the ingredients required for tooth care. Chewable toothpaste tablets have the advantage of being able to be unpacked and put into the mouth, then chewed off and brushed with a wet toothbrush.

The use of herbal products in dentifrice is proving to be a potential and effective competitor to conventional synthetic compounds.

In light of the above advantages, the present study attempts to compare and evaluate the efficacy of commercially available herbal toothpaste tablets and regular toothpaste in the reduction of plaque and gingivitis.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Males or females ≥ 18 years of age with a minimum of 25 teeth
  • Baseline mean whole-mouth plaque index ≥ 1.0
  • Baseline mean whole-mouth modified gingival index ≥ 1.0
  • Ability to provide written informed consent and comply with study visits as described in the protocol, and
  • Availability for follow up via telephone.

Exclusion Criteria

  • Pregnant females
  • Participation in another clinical trial
  • History of periodontitis
  • History of any systemic diseases or conditions.

Outcomes

Primary Outcomes

1. Plaque Index (PI): Quigley Hein with Turesky modification

Time Frame: Baseline | 15th day | 30th day

2. Modified Gingival Index (MGI)

Time Frame: Baseline | 15th day | 30th day

3. Modified Sulcus Bleeding Index (mSBI)

Time Frame: Baseline | 15th day | 30th day

Secondary Outcomes

  • Efficacy of herbal toothpaste tablets compared to conventional toothpaste.(1 month)

Investigators

Sponsor
Dr. Haritha Avula
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Haritha Avula

SRI BALAJI DENTAL COLLEGE

Study Sites (1)

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