NCT06016933

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

August 24, 2023

Last Update Submit

August 24, 2023

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Plaque Index

    3 months

  • Gingival index

    3 months

Study Arms (2)

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

PLACEBO COMPARATOR
Procedure: SRP of all teeth

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

ACTIVE COMPARATOR
Drug: spirulina gelProcedure: SRP of all teeth

Interventions

spirulina gelDRUG

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

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

Patients received oral hygiene instructions and SRP of all teeth.

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.

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All the patients suffer from stage II, grade B periodonitis with attachment loss 3-4 mm and probing pocket depth ≤ 5mm.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University

Tanta, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. of Oral Medicine and Periodontology

Study Record Dates

First Submitted

August 24, 2023

First Posted

August 30, 2023

Study Start

July 1, 2022

Primary Completion

March 1, 2023

Study Completion

July 22, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

EG(1)