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Effect of Spirulina on Periodontitis

Primary Purpose

Periodontitis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

spirulina gel

SRP of all teeth

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kafrelsheikh University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

oral hygiene instructions and SRP of all teeth plus placebo gel.

oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.

Arm Description

Outcomes

Primary Outcome Measures

Clinical attachment level

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

Probing pocket depth

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

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.

Secondary Outcome Measures

Plaque Index

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

Gingival index

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

Full Information

NCT ID

NCT06016933

First Posted

August 24, 2023

Last Updated

August 24, 2023

Sponsor

Kafrelsheikh University

1. Study Identification

Unique Protocol Identification Number

NCT06016933

Brief Title

Effect of Spirulina on Periodontitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

March 1, 2023 (Actual)

Study Completion Date

July 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kafrelsheikh University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

oral hygiene instructions and SRP of all teeth plus placebo gel.

Arm Type

Placebo Comparator

Arm Title

oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

spirulina gel

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

SRP of all teeth

Intervention Description

Patients received oral hygiene instructions and SRP of all teeth.

Primary Outcome Measure Information:

Title

Clinical attachment level

Description

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

Time Frame

3 months

Title

Probing pocket depth

Description

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

Time Frame

3 months

Title

Interleukin 6.

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Plaque Index

Description

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

Time Frame

3 months

Title

Gingival index

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Kafrelsheikh University

City

Tanta

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Effect of Spirulina on Periodontitis

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