Anti Plaque Efficacy of Salvadora Persica L. and Green Tea Mouthwash

NCT03790904 | Completed Phase 2

• 1 other identifier: 011618
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontal diseases and caries are essentially initiated and progressed by accumulation of dental plaque. Thus, daily effective plaque control is valuable as a preventive measure and maintaining oral health. Mechanical plaque control is important but has limitations; therefore, an adjunctive chemical plaque control such as mouthwash is helpful. Various medicinal plant-derived galenicals might be used as safe and stable alternatives to synthetic mouthwashes. For example, a combination of Salvadora persica L. (Sp) root sticks and green tea (Gt) aqueous extract has been found to reduce plaque accumulation over 24 hours. Moreover, these 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 in reducing plaque buildup for 4 days duration.

Conditions

Periodontal Diseases

Keywords

Dental plaque,; Tea; Salvadora; Mouthwash; Clinical trial

Outcome Measures

Primary Outcomes (2)

• Mean amount plaque between different comparators

  Mean amount plaque between different comparators as anti-plaque agent following 24 hrs plaque regrowth clinical trial by means of modified quigely hein plaque index \[Turesky, 1970\] and digital plaque image analysis.

  Time Frame: 24 hours

• Mean amount plaque between different comparators

  Mean amount plaque between different comparators as anti-plaque agent following 4 days plaque regrowth clinical trial by means of modified quigely hein plaque index \[Turesky, 1970\] and digital plaque image analysis.

  Time Frame: 4 days

Secondary Outcomes (3)

• Mean bacterial load in saliva

  2 hours

• Mean relative changes in gingival crevicular fluid flow rate

  4 days

• Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid

  4 days

Study Arms (3)

Co. mouthwash

ACTIVE COMPARATOR

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

Other: Co.

Kin mouthwash

PLACEBO COMPARATOR

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

Other: Kin

Distilled water

PLACEBO COMPARATOR

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

Other: Distilled water

Interventions

Co. OTHER

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

Co. mouthwash

Kin OTHER

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

Kin mouthwash

Distilled water OTHER

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

Distilled water

Eligibility Criteria

• Age: 20 Years - 23 Years
• Sex: all
• 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 Baghdad: lead

Study Sites (1)

Hayder R Abdulbaqi

Baghdad, 10011, Iraq

Location

MeSH Terms

Conditions

Periodontal Diseases; Dental Plaque

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Officials

• Rasha S Abbood

  University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 2, 2019
• Study Start: January 10, 2019
• Primary Completion: March 31, 2019
• Study Completion: April 9, 2019
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

IR (1)