The Effects of Green Tea and Salvadora Persica L. in Patients With Gingivitis

NCT06211309 | Unknown Phase 2

• 1 other identifier: 857623
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Gingivitis is an inflammatory condition of the gingival tissue, most commonly caused by bacterial infection.The plaque control is considered the most important preventive factor concerning caries, gingivitis, and periodontitis Mechanical means of plaque control, e.g. tooth brushing, flossing and use of other mechanical devices are the most commonly used methods. However, ideal plaque control solely by mechanical means requires a significant effort and is difficult to achieve.This has led to the introduction of chemical methods of plaque control using antimicrobial agentsMore specifically, chemotherapeutic agents with antimicrobial properties, such as 0.12% chlorhexidine (CHX).chx has side effects encourage the need to develop alternative mouthwashes with similar efficacy but without these issues.hence the mouthwash enriched with a combination of aqueous extracts of Salvadora persica L. and green tea used as a substitution to CHX with minimal side effects .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 and gingivitis for 4 weeks duration.

Conditions

Gingivitis

Keywords

Dental plaque; Salvadora; Green tea; Mouthwash; Clinical trial

Outcome Measures

Primary Outcomes (1)

• change in plaque index

  Mean amount plaque between different comparators. Mean amount plaque between different comparators as anti-plaque agent after rinsing with different comparators using means of modified quigely hein plaque index\[ Turesky ,1970

  0-30 days

Secondary Outcomes (3)

• Change in BOP score

  0-30 Days

• change in Gingival index

  0-30 days

• Mean relative change in cytokine interleukin-6 level in salivary Fluid

  0-30 days

Study Arms (3)

co.mouthwash

ACTIVE COMPARATOR

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

Drug: co.mouthwas

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.mouthwas DRUG

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

Also known as: co

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: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects aged more than 15 years-old who will volunteer to participate.
• Participants who were apparently systemically healthy.
• Not taking antibiotic and anti-inflammatory drugs in the last three months
• Patients having generalized gingivitis with intact periodontium in which they have more than 30% bleeding sites with no PPD \>3 mm with no clinical attachment loss according to criteria proposed by

You may not qualify if:

• Those with history of systemic chronic disease, immunocompromised patients.
• Those currently using any mouthwash.
• Those on antibiotic therapy, anti-inflammatory medications or NSAID during the study and at the last 3 months before the study.
• Those having a history of hypersensitivity to any product used in the present study.
• Those having periodontitis.
• Those who smoker or alcoholism.
• handicapped patient or patients with limited manual dexterities.
• pregnant , lactating women or taking contraceptive pills.
• Subjects wearing orthodontic appliances or removable dentures.
• patients unwilling to participate in study.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Aliaa

Baghdad, 10011, Iraq

RECRUITING

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Design

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

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

IR (1)