A Phase 2 interventional study of microneedling and scaling in Periodontal Diseases, Periodontitis and Treatment Need and Gingivitis, sponsored by Fayoum University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Fayoum University · Phase 2, Interventional, and Treatment
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.
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.
590 studies on the registry are indexed under Gingivitis; 105 are open to participants now.
This study's planned enrollment of 30 is below the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Fayoum University is the lead sponsor of 144 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
biofilm induced gingivitis treated with microneedling \& topical ozonated olive oil
Other: microneedling · Other: scaling · Biological: Ozonated olive oil
Periodontitis cases treated by (PMPR) only.
Other: scaling
Periodontitis cases treated with microneedle (Dermapen) and topical ozonated olive oil.
Other: microneedling · Other: scaling · Biological: Ozonated olive oil
gingival microneedling (small holes in gingiva)
scaling (plaque removal)
ozonated olive oil after microneedling
bleeding on probing
Muehlemann \& Son index
Time frame: 4 weeks
Plaque index
Silness-Loe Plaque Index
Time frame: 4 weeks
probing depth and clinical attachment loss
measured in mm using a UNC 15 probe
Time frame: 4 weeks
malondialdehyde and 8-hydroxy-deoxyguanosin level in GCF.
measured by ELISA
Time frame: 4 weeks
Plan to share: Yes — upon request
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Fayoum University