Clinical trial NCT06211309: The Effects of Green Tea and Salvadora Persica L. in Patients With Gingivitis
Official title: Evaluation of Anti-plaque and Anti-inflammatory Effects of Green Tea and Salvadora Persica L. in Patients With Gingivitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gingivitis
Keywords: Dental plaque
Salvadora
Green tea
Mouthwash
Clinical trial
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 45
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 .

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.

Primary outcomes:
measure: change in plaque index
timeFrame: 0-30 days
Secondary outcomes:
measure: Change in BOP score
timeFrame: 0-30 Days
measure: change in Gingival index
timeFrame: 0-30 days
measure: Mean relative change in cytokine interleukin-6 level in salivary Fluid
timeFrame: 0-30 days
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Aliaa
Study officials:
References: