Effect of Spirulina on Periodontitis

• Sponsor: Kafrelsheikh University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06016933
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.7
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Drug: spirulina gel; Procedure: SRP of all teeth	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effect of Locally Delivered Spirulina Gel on Treatment of Stage II, Grade B Periodontitis
• Actual Study Start Date: Jul 1, 2022
• Actual Primary Completion Date: Mar 1, 2023
• Actual Study Completion Date: Jul 22, 2023

Arms and Interventions

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.	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.

Outcome Measures

Primary Outcome Measures

1. Clinical attachment level [3 months]

   Clinical attachment level was measured at baseline, 1 and 3 months after gel application.

2. Probing pocket depth [3 months]

   Probing pocket depth was measured at baseline, 1 and 3 months after gel application.

3. 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

1. Plaque Index [3 months]

   Plaque index was measured at baseline and at 1, and 3-months post treatment.

2. Gingival index [3 months]

   Gingival index was measured at baseline and at 1, and 3-months post treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kafrelsheikh University	Tanta		Egypt

Sponsors and Collaborators

• Kafrelsheikh University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enas Elgendy, Prof. of Oral Medicine and Periodontology, Kafrelsheikh University
• ClinicalTrials.gov Identifier: NCT06016933
• Other Study ID Numbers: 5
• First Posted: Aug 30, 2023
• Last Update Posted: Aug 30, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontitis

Study Results

No Results Posted as of Aug 30, 2023