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

NCT ID: NCT06211309

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-07-31

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.

Detailed Description

Gingivitis is an inflammatory condition of the gingival tissue, most commonly caused by bacterial infection. Unlike periodontitis, there is no attachment loss and therefore no migration of the junctional epithelium. The condition is restricted to the soft-tissue area of the gingival epithelium and connective tissue.Gingivitis is caused by the microbial plaque deposits located in or close to the gingival sulcus).

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), have been proposed as an adjunct to the standard oral hygiene protocol. 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 .

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

co.mouthwash

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

Group Type: ACTIVE_COMPARATOR

co.mouthwas

Intervention Type: DRUG

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

Kin mouthwash

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

Group Type: PLACEBO_COMPARATOR

Kin

Intervention Type: OTHER

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

Distilled water

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

Group Type: PLACEBO_COMPARATOR

Distilled water

Intervention Type: OTHER

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

Interventions

co.mouthwas

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

Intervention Type: DRUG

Kin

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

Intervention Type: OTHER

Distilled water

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

Intervention Type: OTHER

Other Intervention Names

co

Eligibility Criteria

Inclusion Criteria

1. Subjects aged more than 15 years-old who will volunteer to participate.

2. Participants who were apparently systemically healthy.

3. Not taking antibiotic and anti-inflammatory drugs in the last three months

4. 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

Exclusion Criteria

1. Those with history of systemic chronic disease, immunocompromised patients.

2. Those currently using any mouthwash.

3. Those on antibiotic therapy, anti-inflammatory medications or NSAID during the study and at the last 3 months before the study.

4. Those having a history of hypersensitivity to any product used in the present study.

5. Those having periodontitis.

6. Those who smoker or alcoholism.

7. handicapped patient or patients with limited manual dexterities.

8. pregnant , lactating women or taking contraceptive pills.

9. Subjects wearing orthodontic appliances or removable dentures.

10. patients unwilling to participate in study.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Aliaa Saeed Salman

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aliaa

Baghdad, , Iraq

Site Status: RECRUITING

Countries

Iraq

Facility Contacts

Aliaa saeed salman, master

Role: primary

Alaia.saeed2205@codental.edu.iq

0771 581 4202 ext. 0096

Other Identifiers

857623

Identifier Type: -

Identifier Source: org_study_id