Evaluation of Synergistic Anti-plaque Activity of Salvadora Persica L. and Green Tea: A Clinical Comparative Study (ESAA)

December 7, 2015 updated by: University of Malaya
Accumulation of dental plaque may result in negative effects on the tooth and tooth supporting periodontal tissue. In addition, it contributes to the development of caries and periodontal diseases. Therefore, an effective dental plaque control is essential for maintaining good oral hygiene. Mechanical plaque control has its limitation thus chemical plaque control may be used as an adjunct in dental plaque control. Various types of medicinal plants can be utilized as stable, safe and biologically active plant-derived galenicals as alternative to synthetic mouth wash. Among these plants, Salvadora persica L. (Sp) root sticks and green tea (Gt) aqueous extracts were reported to have anti-microbial activity against many oral bacteria. The objective of this study was to investigate the efficacy of the combination of Gt aqueous extract and Sp aqueous extract as a synergistic anti-bacterial and anti-adherence efficacy against primary plaque colonizers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dental plaque is the soft deposits that form the biofilm adhering to the tooth surface or other hard surfaces inside oral cavity, including removable and fixed restoration. The dental plaque is composed of over 500 bacterial species. The colonization of these bacteria follows a special pattern starting by adhesion of initial bacterial colonizers to the salivary pellicles covering tooth enamel and other hard surfaces in the oral cavity followed by secondary colonization of follower bacteria through inter-bacterial adhesion leading to dental plaque maturation.

Periodontal health can be considered to be in a state of balance when the bacterial mass presents in the host oral cavity and causes no damage to either the bacteria or the host periodontal tissues. Any disruption of this balance results in alterations in both the host periodontal and biofilm bacteria and leads ultimately to destruction of the periodontium. Accumulation of dental plaque may lead to several harmful effects on the tooth and tooth supporting periodontal tissue that contributes to the development of caries and periodontal diseases. Therefore, an effective dental plaque control is essential for maintaining good oral hygiene.

Mechanical plaque control, by using toothbrushes and interdental aids, is the mostly adopted method. Unfortunately, it is a time consuming process and needs high manual dexterity. Moreover, epidemiological studies revealed high prevalence of gingivitis among toothbrush users. Hence, chemical plaque control may be used to assist in dental plaque control.

The anti-plaque agent is that agent that interferes with one of the different phases of dental plaque development: interferes with the adhesion of oral bacteria to oral surfaces and prevent biofilm formation; interferes with co-aggregation mechanism which thereby prevents future growth of micro-colonies; or removes or disrupts existing dental plaque. To date, chlorhexidine (CHX) mouthwash is the standard solution used in chemical plaque control, but it was found to have several side effects including tooth and some restorations staining, unpleasant test, sloughing of oral mucosa and enhancement of supra-gingival calculus formation.

The widely available traditional natural medicinal plants can be utilized as stable, safe and biologically active plant-derived galenicals as alternative to synthetic drugs. Among these plants, Salvadora persica L. (Sp) root sticks and green tea (Gt), leafs of Camellia sinensis. Kuntze, aqueous extracts were reported to have anti-microbial activity against many oral bacteria. In our in vitro study, we found that the combination (Co.) of 0.25mg Gt aqueous extract and 7.82mg Sp aqueous extract in 1ml exhibited significant synergistic anti-bacterial and anti-adherence efficacy against primary plaque colonizers.

The dental plaque is classified into two categories, supra-gingival plaque and sub-gingival plaque, in relation to gingival margin. The supra-gingival dental plaque may be readily visualized on teeth after 24 to 48 hours with no oral hygiene measures and it appears white, grayish, or yellow in color and has a globular appearance.

Supra-gingival plaque accumulation on tooth surfaces can be quantified through different plaque index systems. In this study, the clinical parameter to record plaque quantity was modified Quigely Hein Plaque Index. In this index, a score of 0 to 5 was assigned for each facial and lingual (palatal) surface of all teeth except the third molars.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Participants should be medically healthy.
  • Participants should have more than 20 teeth.

Exclusion Criteria:

  • Participants who have active cavity caries and/or periodontal disease.
  • Participants who have ongoing orthodontic treatment.
  • Participants who have been on antibiotics within the past 4 months.
  • Participants who require prophylactic antibiotic coverage.
  • Participants who have been on systemic or topical non-steroidal anti-inflammatory drugs for the past 4 months.
  • Participants who are pregnant or intended to and lactating mother.
  • Participants who have heart valve replacement and have known intolerance or allergy to mouth rinses.
  • Participants who have any systemic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Distilled water
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Other: Distilled water
15ml distilled water twice a day, rinse for 30sec refrain from eating or drinking for 30min
Active Comparator: DTC1 mouth wash
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Other: DTC1
15ml DTC1 twice a day, rinse for 30sec refrain from eating or drinking for 30min
Placebo Comparator: Oradex mouth wash
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Other: Oradex
15ml Chlorhexidine gluconate 0.12% (w/v) twice a day, rinse for 30sec refrain from eating or drinking for 30min
Other Names:
  • CHX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean amount plaque between different DTC1 and placebo comparators i.e. Oradex and distilled water, as anti-plaque agent following 24 hrs plaque regrowth clinical trial by means of modified Quigely Hein Plaque Index [Turesky, 1970].
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Nor_Adinar Baharuddin, DClinDent, University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 8, 2015

Study Record Updates

Last Update Posted (Estimate)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 101269-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe