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Completed

NCT Number: NCT06016933

Effect of Spirulina on Periodontitis

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

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Tanta, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

spirulina gel

Drug

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

SRP of all teeth

Procedure

Patients received oral hygiene instructions and SRP of all teeth.

Primary outcomes

  1. Clinical attachment level

    Time frame: 3 months

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

  2. Probing pocket depth

    Time frame: 3 months

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

  3. Interleukin 6.

    Time frame: 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 outcomes

  1. Plaque Index

    Time frame: 3 months

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

  2. Gingival index

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2023
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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