Effect of Spirulina on Periodontitis

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Procedure: SRP of all teeth; Drug: spirulina gel

• Registration Number: NCT06016933
• Lead Sponsor: Kafrelsheikh University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-07-22
• Status Verified: 2023-08
• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Study First Posted: 2023-08-30
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral hygiene instructions and SRP of all teeth plus placebo gel.	SRP of all teeth	-
oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.	spirulina gel	-
oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.	SRP of all teeth	-

Primary Outcome Measures

Name	Time	Method
Clinical attachment level	3 months	Clinical attachment level was measured at baseline, 1 and 3 months after gel application.
Probing pocket depth	3 months	Probing pocket depth was measured at baseline, 1 and 3 months after gel application.
Interleukin 6.	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Plaque Index	3 months	Plaque index was measured at baseline and at 1, and 3-months post treatment.
Gingival index	3 months	Gingival index was measured at baseline and at 1, and 3-months post treatment.

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Tanta, Egypt