"Comparison of Spirulina Gels for Treating Stage II Grade B Periodontitis"

NCT ID: NCT06699654

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-21

Study Completion Date

2025-05-01

Brief Summary

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This randomized controlled clinical study investigates the effectiveness of Spirulina gel and Spirulina nanoparticles gel in treating Stage II Grade B periodontitis. The research aims to compare the two formulations in terms of clinical, radiological, and biochemical outcomes, such as pocket depth reduction, alveolar bone density improvement, and inflammatory marker levels. The study seeks to provide insights into the potential of Spirulina-based therapies for enhancing periodontal health.

Detailed Description

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Conditions

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Periodontitis Stage II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to one of three arms: Spirulina Gel, Spirulina Nanoparticles Gel, or control. The interventions are administered over a defined period with radiological and biochemical assessments conducted at baseline and post-treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group I (control group)

Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth plus placebo gel instillation in the pocket.

Group Type PLACEBO_COMPARATOR

Placebo gel

Intervention Type OTHER

A gel without active Spirulina components applied as a control intervention.

Group II (experimental I)

Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth followed by insertion of the spirulina gel instillation in the deepest selected periodontal pocket after drying the area around it.

Group Type ACTIVE_COMPARATOR

Spirulina Gel

Intervention Type DIETARY_SUPPLEMENT

A conventional Spirulina gel formulation applied as a periodontal therapy.

Group III (experimental II)

Participants in this arm will receive oral hygiene instruction and full mouth SRP of all teeth followed by insertion of the spirulina nanogel instillation in the deepest selected periodontal pocket after drying the area around it.

Group Type EXPERIMENTAL

Spirulina Nanoparticles Gel

Intervention Type DIETARY_SUPPLEMENT

A novel Spirulina nanoparticles gel formulation applied as a periodontal therapy.

Interventions

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Placebo gel

A gel without active Spirulina components applied as a control intervention.

Intervention Type OTHER

Spirulina Gel

A conventional Spirulina gel formulation applied as a periodontal therapy.

Intervention Type DIETARY_SUPPLEMENT

Spirulina Nanoparticles Gel

A novel Spirulina nanoparticles gel formulation applied as a periodontal therapy.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients with good systemic health.
* Patients who can maintain good oral hygiene.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Samir Mohamed Ahmed Algarf

B.D.S. (2017) Misr University for Science and Technology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enas Elgendy, Prof.Dr

Role: STUDY_DIRECTOR

Kafrelsheikh University

Locations

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Doctor Mohamed Samir Periodontal and Implantology Clinic

El-Sheikh Zayed City, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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KFSIRB200-68

Identifier Type: -

Identifier Source: org_study_id

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