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

Healthy Volunteers Clinical Trial

— ESAA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624336
• Other study ID #: 101269-2
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2015
• Last updated: December 7, 2015
• Start date: February 2015
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• DTC1
15ml DTC1 twice a day, rinse for 30sec refrain from eating or drinking for 30min
• Oradex
15ml Chlorhexidine gluconate 0.12% (w/v) twice a day, rinse for 30sec refrain from eating or drinking for 30min
• Distilled water
15ml distilled water twice a day, rinse for 30sec refrain from eating or drinking for 30min

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

References & Publications (15)

Addy M, Moran J, Newcombe R, Warren P. The comparative tea staining potential of phenolic, chlorhexidine and anti-adhesive mouthrinses. J Clin Periodontol. 1995 Dec;22(12):923-8. — View Citation

Allison DG, Gilbert P. Modification by surface association of antimicrobial susceptibility of bacterial populations. J Ind Microbiol. 1995 Oct;15(4):311-7. — View Citation

Baehni PC, Takeuchi Y. Anti-plaque agents in the prevention of biofilm-associated oral diseases. Oral Dis. 2003;9 Suppl 1:23-9. Review. — View Citation

Chelli-Chentouf N, Tir Touil Meddah A, Mullié C, Aoues A, Meddah B. In vitro and in vivo antimicrobial activity of Algerian Hoggar Salvadora persica L. extracts against microbial strains from children's oral cavity. J Ethnopharmacol. 2012 Oct 31;144(1):57-66. doi: 10.1016/j.jep.2012.08.025. Epub 2012 Aug 29. — View Citation

Dhar V, Jain A, Van Dyke TE, Kohli A. Prevalence of gingival diseases, malocclusion and fluorosis in school-going children of rural areas in Udaipur district. J Indian Soc Pedod Prev Dent. 2007 Apr-Jun;25(2):103-5. — View Citation

Farnsworth NR, Akerele O, Bingel AS, Soejarto DD, Guo Z. Medicinal plants in therapy. Bull World Health Organ. 1985;63(6):965-81. — View Citation

Helldén L, Camosci D, Hock J, Tinanoff N. Clinical study to compare the effect of stannous fluoride and chlorhexidine mouthrinses on plaque formation. J Clin Periodontol. 1981 Feb;8(1):12-6. — View Citation

Ismail AI, Szpunar SM. The prevalence of total tooth loss, dental caries, and periodontal disease among Mexican Americans, Cuban Americans, and Puerto Ricans: findings from HHANES 1982-1984. Am J Public Health. 1990 Dec;80 Suppl:66-70. — View Citation

Manganiello AD, Socransky SS, Smith C, Propas D, Oram V, Dogon IL. Attempts to increase viable count recovery of human supragingival dental plaque. J Periodontal Res. 1977 Mar;12(2):107-19. — View Citation

Rosan B, Lamont RJ. Dental plaque formation. Microbes Infect. 2000 Nov;2(13):1599-607. Review. — View Citation

Sofrata A, Brito F, Al-Otaibi M, Gustafsson A. Short term clinical effect of active and inactive Salvadora persica miswak on dental plaque and gingivitis. J Ethnopharmacol. 2011 Oct 11;137(3):1130-4. doi: 10.1016/j.jep.2011.07.034. Epub 2011 Jul 20. — View Citation

Sofrata A, Santangelo EM, Azeem M, Borg-Karlson AK, Gustafsson A, Pütsep K. Benzyl isothiocyanate, a major component from the roots of Salvadora persica is highly active against Gram-negative bacteria. PLoS One. 2011;6(8):e23045. doi: 10.1371/journal.pone.0023045. Epub 2011 Aug 1. — View Citation

Teles RP, Teles FR. Antimicrobial agents used in the control of periodontal biofilms: effective adjuncts to mechanical plaque control? Braz Oral Res. 2009;23 Suppl 1:39-48. Review. — View Citation

Tsai TH, Tsai TH, Chien YC, Lee CW, Tsai PJ. In vitro antimicrobial activities against cariogenic streptococci and their antioxidant capacities: A comparative study of green tea versus different herbs. Food Chem. 2008 Oct 15;110(4):859-64. doi: 10.1016/j.foodchem.2008.02.085. Epub 2008 Mar 4. — View Citation

Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].		24 hours	No