Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06990282

Micro-Needling Technique Using Ozonated Olive Oil in Periodontal Diseases

The research idea is based on using micro-acupuncture therapy with ozone-treated olive oil to improve the condition of patients suffering from gingivitis and periodontitis and comparing it to the scientifically proven conventional treatment. This is a randomized controlled study, and this idea was chosen from the current general trend in medicine, particularly in dentistry, to use natural sources for treatment due to fewer side effects compared to the chemicals used.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fayoum University

Al Fayyum, Egypt

About this study

The research idea is based on the use of microneedling treatment with ozone-treated olive oil to improve the condition of patients suffering from gingivitis and periodontitis, and to compare this with scientifically proven traditional treatment. It is a randomized controlled study, and this idea has been selected from the general trend currently prevalent in the field of medicine in general and dentistry in particular, which utilizes natural sources for treatment due to the reduced side effects compared to chemical substances used. Research objectives and rationale: to find simple, proven solutions accessible to everyone that rely on natural sources to treat one of the widely spread oral diseases, which negatively affects the patient's overall health and dental health, potentially leading to tooth loss and deteriorating the patient's oral and psychological health as well. The proposed solutions will be compared with scientifically proven solutions that are used regularly to treat this disease. Expected results: that the new intervention using ozone-treated natural olive oil with the microneedling device, which has shown significant effectiveness in various specialties such as dermatology and dentistry, will improve the healing process of the gum membranes And the removal of the inflammations causing deterioration of the membranes surrounding the teeth and the bone resorption around them, which may lead to tooth loss, should improve better than the conventional methods currently used. This involves using laboratory analyses to observe the improvement rates of biological indicators by taking a sample of the gingival crevicular fluid before starting the intervention and afterward, with regular patient follow-up until clinical signs improve. Multiple readings should be taken to assess the improvement in the quality of the membranes, ensuring that the new intervention is simple and accessible to everyone. Operational background: This research is based on numerous previous studies from references, case reports, and analytical studies in the same field published in international scientific journals. Their effectiveness and credibility have been proven by specialists through published systematic reviews, along with the opinions of specialized consultants.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-60 years old
  • Male and female medically free participants
  • Patients suffering from biofilm induced gingivitis or periodontitis

Exclusion criteria

  • Smoking and tobacco related habits
  • Non-biofilm induced gingival diseases
  • Necrotizing periodontal diseases
  • periodontitis as a manifestation of systemic disease
  • Third molar tooth

Treatment and study plan

Microneedling

Other

gingival microneedling (small holes in gingiva)

scaling

Other

scaling (plaque removal)

Ozonated olive oil

Biological

ozonated olive oil after microneedling

Primary outcomes

  1. bleeding on probing

    Time frame: 4 weeks

    Muehlemann & Son index

  2. Plaque index

    Time frame: 4 weeks

    Silness-Loe Plaque Index

  3. probing depth and clinical attachment loss

    Time frame: 4 weeks

    measured in mm using a UNC 15 probe

Secondary outcomes

  1. malondialdehyde and 8-hydroxy-deoxyguanosin level in GCF.

    Time frame: 4 weeks

    measured by ELISA

Study contacts

Contact information is provided by the study sponsor or research team.

heba Alnjar

CONTACT

[email protected]

+201023717086

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

The Effectiveness of Micro-Needling Technique Using Ozonated Olive Oil on The Treatment of Biofilm Induced Gingivitis & Periodontitis in Comparison to Professional Mechanical Plaque Removal: A Randomized Control Trial.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2025
Registry last updated
May 25, 2025

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.

Published trials that share one or more normalized conditions with this study.