Micro-Needling Technique Using Ozonated Olive Oil in Periodontal Diseases

Phase 2

Not yet recruiting

• Conditions: Periodontal Diseases; Periodontitis and Treatment Need; Gingivitis
• Interventions: Other: microneedling; Other: scaling; Biological: Ozonated olive oil

• Registration Number: NCT06990282
• Lead Sponsor: Fayoum University

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Study Start: 2025-07-01
• Primary Completion: 2026-02
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
biofilm induced gingivitis treated with microneedling & topical ozonated olive oil.	microneedling	biofilm induced gingivitis treated with microneedling \& topical ozonated olive oil
biofilm induced gingivitis treated with microneedling & topical ozonated olive oil.	scaling	biofilm induced gingivitis treated with microneedling \& topical ozonated olive oil
biofilm induced gingivitis treated with microneedling & topical ozonated olive oil.	Ozonated olive oil	biofilm induced gingivitis treated with microneedling \& topical ozonated olive oil
Periodontitis cases treated by scaling only.	scaling	Periodontitis cases treated by (PMPR) only.
Periodontitis cases treated with microneedling and topical ozonated olive oil.	microneedling	Periodontitis cases treated with microneedle (Dermapen) and topical ozonated olive oil.
Periodontitis cases treated with microneedling and topical ozonated olive oil.	scaling	Periodontitis cases treated with microneedle (Dermapen) and topical ozonated olive oil.
Periodontitis cases treated with microneedling and topical ozonated olive oil.	Ozonated olive oil	Periodontitis cases treated with microneedle (Dermapen) and topical ozonated olive oil.

Primary Outcome Measures

Name	Time	Method
probing depth and clinical attachment loss	4 weeks	measured in mm using a UNC 15 probe
bleeding on probing	4 weeks	Muehlemann \& Son index
Plaque index	4 weeks	Silness-Loe Plaque Index

Secondary Outcome Measures

Name	Time	Method
malondialdehyde and 8-hydroxy-deoxyguanosin level in GCF.	4 weeks	measured by ELISA

Trial Locations

Locations (1)

Fayoum University; 🇪🇬 Fayoum, Egypt