Clinical trial NCT06990282: Micro-Needling Technique Using Ozonated Olive Oil in Periodontal Diseases
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Periodontal Diseases
Periodontitis and Treatment Need
Gingivitis
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: microneedling and ozonated olive oil
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: bleeding on probing
timeFrame: 4 weeks
measure: Plaque index
timeFrame: 4 weeks
measure: probing depth and clinical attachment loss
timeFrame: 4 weeks
Secondary outcomes:
measure: malondialdehyde and 8-hydroxy-deoxyguanosin level in GCF.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
affiliation: Fayoum University
name: Nayroz Tarrad, Prof
role: STUDY_DIRECTOR
References: