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Not yet recruiting NCT06990282

Micro-Needling Technique Using Ozonated Olive Oil in Periodontal Diseases

Phase II Interventional Periodontal Diseases Periodontitis and Treatment Need Gingivitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: microneedling, scaling, Ozonated olive oil.
Who it may be relevant to
Registry conditions: Periodontal Diseases, Periodontitis and Treatment Need, Gingivitis. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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.

Overview

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.

Detailed description

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.

Interventions

  • Other microneedling
    gingival microneedling (small holes in gingiva)
  • Other scaling
    scaling (plaque removal)
  • Biological Ozonated olive oil
    ozonated olive oil after microneedling

Primary outcome measures

  • bleeding on probing [Time frame: 4 weeks]
  • Plaque index [Time frame: 4 weeks]
  • probing depth and clinical attachment loss [Time frame: 4 weeks]
Secondary outcome measures (1)
  • malondialdehyde and 8-hydroxy-deoxyguanosin level in GCF. [Time frame: 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Fayoum University — Al Fayyum

Identifiers

NCT: NCT06990282 · PNI · fayoum university

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗