Effect of Spirulina on Periodontitis

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

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

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: SRP of all teeth; Drug: spirulina gel

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: oral hygiene instructions and SRP of all teeth plus placebo gel.	Procedure: SRP of all teeth; Patients received oral hygiene instructions and SRP of all teeth.
Active Comparator: oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.	Procedure: SRP of all teeth; Patients received oral hygiene instructions and SRP of all teeth.; Drug: spirulina gel; Patient were received spirulina gel in diseased sites. The process will be repeated at 7, 14, 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level	Clinical attachment level was measured at baseline, 1 and 3 months after gel application.	3 months
Probing pocket depth	Probing pocket depth was measured at baseline, 1 and 3 months after gel application.	3 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index	Plaque index was measured at baseline and at 1, and 3-months post treatment.	3 months
Gingival index	Gingival index was measured at baseline and at 1, and 3-months post treatment.	3 months

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): July 22, 2023

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No