Effect of Spirulina on Periodontitis

Periodontitis Clinical Trial

Official title:

Effect of Locally Delivered Spirulina Gel on Treatment of Stage II, Grade B Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06016933
• Other study ID #: 5
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 22, 2023

Study information

• Verified date: August 2023
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the clinical and immunological effect of spirulina in treatment of stage II periodontitis.

Description:

In this study, the investigators tested the effect of spirulina gel as adjunctive of scaling and root planing in treatment of stage II, grade B periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and level of interleukin 6.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 22, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

Inclusion Criteria:

• All the patients suffer from stage II, grade B periodonitis with attachment loss 3-4 mm and probing pocket depth = 5mm.

Exclusion Criteria:

• Any systemic disease that affects the periodontium. ·

• Pregnant, postmenopausal women. ·

• People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 3 month.

• People who use mouth washes regularly ·

• Participation in other clinical trials.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• spirulina gel
Patient were received spirulina gel in diseased sites. The process will be repeated at 7, 14, 21 days.

Procedure:
• SRP of all teeth
Patients received oral hygiene instructions and SRP of all teeth.

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level	Clinical attachment level was measured at baseline, 1 and 3 months after gel application.	3 months
Primary	Probing pocket depth	Probing pocket depth was measured at baseline, 1 and 3 months after gel application.	3 months
Primary	Interleukin 6.	Enzyme linked immune-assay for the quantitative measurement of interleukin 6 concentration in gingival cervicular fluid at baseline, 1 and 3 months after gel application.	3 months
Secondary	Plaque Index	Plaque index was measured at baseline and at 1, and 3-months post treatment.	3 months
Secondary	Gingival index	Gingival index was measured at baseline and at 1, and 3-months post treatment.	3 months