Periodontal DiseasesPhase 2NCT06990282
Micro-Needling Technique Using Ozonated Olive Oil in Periodontal Diseases
A Phase 2 study testing microneedling, scaling and Ozonated olive oil in people with Periodontal Diseases and Periodontitis and Treatment Need, run by Fayoum University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontal Diseases, Periodontitis and Treatment Need, Gingivitis
- What is being tested?
- microneedling, scaling and Ozonated olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years old
- Male and female medically free participants
- Patients suffering from biofilm induced gingivitis or periodontitis
Who cannot join
- Smoking and tobacco related habits
- Non-biofilm induced gingival diseases
- Necrotizing periodontal diseases
- periodontitis as a manifestation of systemic disease
- Third molar tooth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
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.
Read the 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.
- Being tested
- microneedling, scaling, Ozonated olive oil
- Medical subject headings
- Periodontal Diseases, Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microneedlingOther
gingival microneedling (small holes in gingiva)
scalingOther
scaling (plaque removal)
Ozonated olive oilBiological
ozonated olive oil after microneedling
| Study group | Role | What they receive |
|---|---|---|
| biofilm induced gingivitis treated with microneedling & topical ozonated olive oil. | Experimental | biofilm induced gingivitis treated with microneedling \& topical ozonated olive oil Receives: Other: microneedling; Other: scaling; Biological: Ozonated olive oil |
| Periodontitis cases treated by scaling only. | Experimental | Periodontitis cases treated by (PMPR) only. Receives: Other: scaling |
| Periodontitis cases treated with microneedling and topical ozonated olive oil. | Experimental | Periodontitis cases treated with microneedle (Dermapen) and topical ozonated olive oil. Receives: Other: microneedling; Other: scaling; Biological: Ozonated olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding on probing
Muehlemann \& Son index
Measured: 4 weeks
Plaque index
Silness-Loe Plaque Index
Measured: 4 weeks
probing depth and clinical attachment loss
measured in mm using a UNC 15 probe
Measured: 4 weeks
Secondary outcomes (1)
malondialdehyde and 8-hydroxy-deoxyguanosin level in GCF.
measured by ELISA
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- microneedling and ozonated olive oil
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mohammed Hussien Ali, Fayoum University
- Investigators
- Nayroz Tarrad, Prof, Study director, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990282
- Sponsor's protocol ID
- PNI
- Other IDs
- fayoum university
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon request
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06990282
- Acronym / sponsor ID
- PNI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- microneedling and ozonated olive oil
| Arm | Type | Receives |
|---|---|---|
| biofilm induced gingivitis treated with microneedling & topical ozonated olive oil. | Experimental | Other: microneedling, Other: scaling, Biological: Ozonated olive oilbiofilm induced gingivitis treated with microneedling \& topical ozonated olive oil |
| Periodontitis cases treated by scaling only. | Experimental | Other: scalingPeriodontitis cases treated by (PMPR) only. |
| Periodontitis cases treated with microneedling and topical ozonated olive oil. | Experimental | Other: microneedling, Other: scaling, Biological: Ozonated olive oilPeriodontitis cases treated with microneedle (Dermapen) and topical ozonated olive oil. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years old
- Male and female medically free participants
- Patients suffering from biofilm induced gingivitis or periodontitis
Key exclusion criteria (5 listed)
- Smoking and tobacco related habits
- Non-biofilm induced gingival diseases
- Necrotizing periodontal diseases
- periodontitis as a manifestation of systemic disease
- Third molar tooth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microneedlinggingival microneedling (small holes in gingiva) | Other | Periodontitis cases treated with microneedling and topical ozonated olive oil., biofilm induced gingivitis treated with microneedling & topical ozonated olive oil. |
| scalingscaling (plaque removal) | Other | Periodontitis cases treated by scaling only., Periodontitis cases treated with microneedling and topical ozonated olive oil., biofilm induced gingivitis treated with microneedling & topical ozonated olive oil. |
| Ozonated olive oilozonated olive oil after microneedling | Biological | Periodontitis cases treated with microneedling and topical ozonated olive oil., biofilm induced gingivitis treated with microneedling & topical ozonated olive oil. |
Primary outcome
bleeding on probing
Time frame: 4 weeks
Muehlemann \& Son index
Plaque index
Time frame: 4 weeks
Silness-Loe Plaque Index
probing depth and clinical attachment loss
Time frame: 4 weeks
measured in mm using a UNC 15 probe
1 secondary outcome
malondialdehyde and 8-hydroxy-deoxyguanosin level in GCF.
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Yes. upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nayroz Tarrad, Prof study director
Fayoum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing microneedling, scaling and Ozonated olive oil in people with Periodontal Diseases and Periodontitis and Treatment Need, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact heba Alnjar (+201023717086, hmh14@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding on probing (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.