Micro-Needling Technique Using Ozonated Olive Oil in Periodontal Diseases

NCT ID: NCT06990282

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-03-31

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.

Conditions

Periodontal Diseases; Periodontitis and Treatment Need; Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

biofilm induced gingivitis treated with microneedling & topical ozonated olive oil.

biofilm induced gingivitis treated with microneedling \& topical ozonated olive oil

Group Type: EXPERIMENTAL

microneedling

Intervention Type: OTHER

gingival microneedling (small holes in gingiva)

scaling

Intervention Type: OTHER

scaling (plaque removal)

Ozonated olive oil

Intervention Type: BIOLOGICAL

ozonated olive oil after microneedling

Periodontitis cases treated by scaling only.

Periodontitis cases treated by (PMPR) only.

Group Type: EXPERIMENTAL

scaling

Intervention Type: OTHER

scaling (plaque removal)

Periodontitis cases treated with microneedling and topical ozonated olive oil.

Periodontitis cases treated with microneedle (Dermapen) and topical ozonated olive oil.

Group Type: EXPERIMENTAL

microneedling

Intervention Type: OTHER

gingival microneedling (small holes in gingiva)

scaling

Intervention Type: OTHER

scaling (plaque removal)

Ozonated olive oil

Intervention Type: BIOLOGICAL

ozonated olive oil after microneedling

Interventions

microneedling

gingival microneedling (small holes in gingiva)

Intervention Type: OTHER

scaling

scaling (plaque removal)

Intervention Type: OTHER

Ozonated olive oil

ozonated olive oil after microneedling

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

Heba Mohammed Hussien Ali

teaching assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nayroz Tarrad, Prof

Role: STUDY_DIRECTOR

Fayoum University

Locations

Fayoum University

Al Fayyum, , Egypt

Countries

Egypt

Central Contacts

heba Alnjar

Role: CONTACT

hmh14@fayoum.edu.eg

+201023717086

Other Identifiers

fayoum university

Identifier Type: OTHER

Identifier Source: secondary_id

PNI

Identifier Type: -

Identifier Source: org_study_id