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

NCT02624336 | Completed Phase 2 DMC

• 1 other identifier: 101269-2
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteers

Keywords

periodontal disease; caries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

DTC1 mouth wash

ACTIVE COMPARATOR

15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min

Other: DTC1

Oradex mouth wash

PLACEBO COMPARATOR

15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min

Other: Oradex

Distilled water

PLACEBO COMPARATOR

15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min

Other: Distilled water

Interventions

DTC1 OTHER

15ml DTC1 twice a day, rinse for 30sec refrain from eating or drinking for 30min

DTC1 mouth wash

Oradex OTHER

15ml Chlorhexidine gluconate 0.12% (w/v) twice a day, rinse for 30sec refrain from eating or drinking for 30min

Also known as: CHX

Oradex mouth wash

Distilled water OTHER

15ml distilled water twice a day, rinse for 30sec refrain from eating or drinking for 30min

Distilled water

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Related Publications (16)

• 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. doi: 10.1111/j.1600-051x.1995.tb01796.x.

  PMID: 8613560 BACKGROUND

• Allison DG, Gilbert P. Modification by surface association of antimicrobial susceptibility of bacterial populations. J Ind Microbiol. 1995 Oct;15(4):311-7. doi: 10.1007/BF01569985.

  PMID: 8605070 BACKGROUND

• Baehni PC, Takeuchi Y. Anti-plaque agents in the prevention of biofilm-associated oral diseases. Oral Dis. 2003;9 Suppl 1:23-9. doi: 10.1034/j.1601-0825.9.s1.5.x.

  PMID: 12974527 BACKGROUND

• Chelli-Chentouf N, Tir Touil Meddah A, Mullie 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.

  PMID: 22963838 BACKGROUND

• 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. doi: 10.4103/0970-4388.33458.

  PMID: 17660647 BACKGROUND

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

  PMID: 3879679 BACKGROUND

• Hellden 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. doi: 10.1111/j.1600-051x.1981.tb02019.x.

  PMID: 7019266 BACKGROUND

• 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(Suppl):66-70. doi: 10.2105/ajph.80.suppl.66.

  PMID: 9187585 BACKGROUND

• 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. doi: 10.1111/j.1600-0765.1977.tb00113.x. No abstract available.

  PMID: 138728 BACKGROUND

• Rosan B, Lamont RJ. Dental plaque formation. Microbes Infect. 2000 Nov;2(13):1599-607. doi: 10.1016/s1286-4579(00)01316-2.

  PMID: 11113379 BACKGROUND

• 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.

  PMID: 21798329 BACKGROUND

• Sofrata A, Santangelo EM, Azeem M, Borg-Karlson AK, Gustafsson A, Putsep 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.

  PMID: 21829688 BACKGROUND

• 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. doi: 10.1590/s1806-83242009000500007.

  PMID: 19838557 BACKGROUND

• 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.

  PMID: 26047271 BACKGROUND

• Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.

  PMID: 5264376 BACKGROUND

• Abdulbaqi HR, Himratul-Aznita WH, Baharuddin NA. Evaluation of Salvadora persica L. and green tea anti-plaque effect: a randomized controlled crossover clinical trial. BMC Complement Altern Med. 2016 Dec 1;16(1):493. doi: 10.1186/s12906-016-1487-0.

  PMID: 27903262 DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Nor_Adinar Baharuddin, DClinDent

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 8, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share