Clinical trial

Evaluation of Anti-plaque and Anti-inflammatory Effects of Green Tea and Salvadora Persica L. in Patients With Gingivitis

Name
857623
Description
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.
Trial arms
Trial start
2024-01-01
Estimated PCD
2024-05-01
Trial end
2024-07-01
Status
Recruiting
Phase
Early phase I
Treatment
co.mouthwas
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Arms:
co.mouthwash
Other names:
co
Kin
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Arms:
Kin mouthwash
Distilled water
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Arms:
Distilled water
Size
45
Primary endpoint
change in plaque index
0-30 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}
Updated at
2024-01-30

1 organization

1 product

1 indication

Indication
Gingivitis