Molar IntrusionNCT07900022
Ozonated Olive Oil for Mini-Screw Complications in Molar Intrusion
A study testing Ozonated Olive Oil and Chlorhexidine in people with Molar Intrusion and Ozonated Olive Oil, run by Yuzuncu Yil University at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this clinical trial was to learn whether ozonated olive oil can reduce complications around orthodontic mini-screws in patients with anterior open bite who receive maxillary molar intrusion as part of fixed orthodontic treatment. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Molar Intrusion, Ozonated Olive Oil, Chlorhexidine
- What is being tested?
- Ozonated Olive Oil and Chlorhexidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Dec 2021to 25 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 12 and 24 years
- Anterior open bite of 0-4 mm requiring fixed orthodontic treatment
- SN-GoGn angle between 26 and 38 degrees
- Indication for maxillary molar intrusion with mini-screws
- Willingness to comply with study instructions
Who cannot join
- Systemic disease
- Medication use before or during the study
- Tobacco use
- Previous use of antimicrobial mouthwash
- Known allergy to the oral care products used
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Van Yuzuncu Yil University, Faculty of Dentistry
Van, Van, (650) 00_-____
Van Yuzuncu Yil University, Faculty of Dentistry
Van, Van, 65100
About this study
Official title: Effect of Ozonated Olive Oil on Mini-Screw Complications During Orthodontic Treatment Combined With Molar Intrusion
The goal of this clinical trial was to learn whether ozonated olive oil can reduce complications around orthodontic mini-screws in patients with anterior open bite who receive maxillary molar intrusion as part of fixed orthodontic treatment. The study also compared ozonated olive oil with chlorhexidine, the antiseptic most commonly used for this purpose.
The main questions it aimed to answer were:
Read more
- Does ozonated olive oil reduce bleeding, plaque accumulation and mobility around mini-screws compared with chlorhexidine?
- Does ozonated olive oil affect pocket depth, bleeding, plaque and mobility of the teeth next to the mini-screws?
- Is pain after mini-screw placement different between the two products?
Each participant received four mini-screws (two buccal, two palatal) in the upper jaw. One side of the mouth was treated with ozonated olive oil spray and the other side with chlorhexidine spray (split-mouth design), and the side for each product was chosen randomly.
Participants:
- Applied 10 sprays per day of each assigned product to its side for 7 days after mini-screw placement
- Attended measurements before treatment, on the day of placement, and on days 7, 14 and 21
- Rated their pain on a visual analog scale at set time points after placement
Read the detailed description
This randomized, split-mouth clinical trial was conducted at the Department of Orthodontics, Faculty of Dentistry, Van Yuzuncu Yil University between 2021 and 2022. Twenty-six patients aged 12 to 24 years with anterior open bite (0-4 mm) and SN-GoGn angles between 26 and 38 degrees, indicated for maxillary molar intrusion, were included.
All patients were treated with 0.018-inch slot Roth brackets. After leveling and alignment, a 0.016x0.022-inch stainless steel archwire was placed. Four self-drilling titanium mini-screws (diameter 1.8 mm) were inserted per patient: buccal mini-screws (8 mm) between the maxillary first and second molars and palatal mini-screws (10 mm) between the maxillary second premolar and first molar (paramedian palate in patients under 18 years). Insertion torque was 5-10 Ncm, controlled with a digital torque screwdriver. A 150 g intrusion force was applied immediately with elastic chains and reactivated every four weeks. In total, 104 mini-screws were placed (52 per group).
The right and left sides of each patient were randomly allocated by envelope method to ozonated olive oil spray or 0.2% chlorhexidine spray, each used as 10 sprays per day for 7 days. All patients were instructed to brush their teeth and the mini-screws three times daily.
Probing pocket depth, plaque index and bleeding index of the mini-screws and adjacent teeth (second premolar, first molar and second molar) were recorded. Tooth and mini-screw mobility were measured with a Periotest M device. Pain was assessed with a visual analog scale. All measurements were performed by the same clinician.
- Conditions
- Molar Intrusion, Ozonated Olive Oil, Chlorhexidine
- Being tested
- Ozonated Olive Oil, Chlorhexidine
- Keywords
- molar intrusion, Open bite, Ozonated olive oil, Chlorhexidine, Orthodontic treatment
- Medical subject headings
- Open Bite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonated Olive OilOther
Ozonated olive oil oral spray (50 mL) applied to the mini-screw sites on the assigned side, 10 sprays per day for 7 days after mini-screw placement.
ChlorhexidineOther
0.2% chlorhexidine gluconate oral spray (Kloroben) applied to the mini-screw sites and adjacent teeth on the contralateral side of the maxilla, 10 sprays per day for 7 days after mini-screw placement. Serves as the active comparator in this split-mouth design.
| Study group | Role | What they receive |
|---|---|---|
| Ozonated Olive Oil | Experimental | Mini-screws and adjacent teeth on one randomly assigned side of the maxilla treated with ozonated olive oil spray (Arifoglu), 10 sprays per day for 7 days after mini-screw placement. Receives: Other: Ozonated Olive Oil |
| Chlorhexidine | Active comparator | Mini-screws and adjacent teeth on the contralateral side of the maxilla treated with 0.2% chlorhexidine gluconate oral spray (Kloroben), 10 sprays per day for 7 days after mini-screw placement. Receives: Other: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Index Around Mini-Screws
Bleeding index recorded around buccal and palatal mini-screws on the ozonated olive oil and chlorhexidine sides.
Measured: Day 0 (mini-screw placement), day 7, day 14 and day 21
Plaque Index Around Mini-Screws
Plaque index recorded around buccal and palatal mini-screws on the ozonated olive oil and chlorhexidine sides.
Measured: Day 0 (mini-screw placement), day 7, day 14 and day 21
Mini-Screw Mobility
Mini-screw mobility measured with Periotest M device (scale from -8 to +50; lower values indicate greater stability).
Measured: Day 0 (mini-screw placement), day 7, day 14 and day 21
Secondary outcomes (3)
Probing Pocket Depth of Teeth Adjacent to Mini-Screws
Probing pocket depth (mm) of maxillary second premolar, first molar and second molar, calculated as the mean of buccal, palatal, mesial, distal and central sites.
Measured: Baseline (before treatment), day 0, day 7, day 14 and day 21
Plaque and Bleeding Indices of Teeth Adjacent to Mini-Screws
Plaque index and bleeding index of maxillary second premolar, first molar and second molar.
Measured: Baseline (before treatment), day 0, day 7, day 14 and day 21
Mobility of Teeth Adjacent to Mini-Screws
Tooth mobility of maxillary second premolar, first molar and second molar measured with Periotest M device (scale from -8 to +50; lower values indicate greater stability).
Measured: Baseline (before treatment), day 0, day 7, day 14 and day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start20 Dec 2021
- Primary completion7 Feb 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar IntrusionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized split-mouth design. In each patient, the right and left sides of the maxilla were randomly allocated by envelope method to ozonated olive oil spray or 0.2% chlorhexidine spray. Each side received one buccal and one palatal mini-screw for molar intrusion (52 mini-screws per group).
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saadet Çınarsoy ciğerim, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900022
- Sponsor's protocol ID
- VAN YYU-KAEK- 02/22.06.2021
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to participant privacy. De-identified data may be made available by the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ozonated Olive Oil on Mini-Screw Complications During Orthodontic Treatment Combined With Molar Intrusion
- ClinicalTrials.gov ID
- NCT07900022
- Acronym / sponsor ID
- VAN YYU-KAEK- 02/22.06.2021
- Conditions
- Molar Intrusion, Ozonated Olive Oil, Chlorhexidine
- Keywords
- molar intrusion, Open bite, Ozonated olive oil, Chlorhexidine, Orthodontic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 28 Oct 2026 (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 goal of this clinical trial was to learn whether ozonated olive oil can reduce complications around orthodontic mini-screws in patients with anterior open bite who receive maxillary molar intrusion as part of fixed orthodontic treatment. The study also compared ozonated olive oil with chlorhexidine, the antiseptic most commonly used for this purpose.
The main questions it aimed to answer were:
- Does ozonated olive oil reduce bleeding, plaque accumulation and mobility around mini-screws compared with chlorhexidine?
- Does ozonated olive oil affect pocket depth, bleeding, plaque and mobility of the teeth next to the mini-screws?
- Is pain after mini-screw placement different between the two products?
Each participant received four mini-screws (two buccal, two palatal) in the upper jaw. One side of the mouth was treated with ozonated olive oil spray and the other side with chlorhexidine spray (split-mouth design), and the side for each product was chosen randomly.
Participants:
- Applied 10 sprays per day of each assigned product to its side for 7 days after mini-screw placement
- Attended measurements before treatment, on the day of placement, and on days 7, 14 and 21
- Rated their pain on a visual analog scale at set time points after placement
Detailed description
This randomized, split-mouth clinical trial was conducted at the Department of Orthodontics, Faculty of Dentistry, Van Yuzuncu Yil University between 2021 and 2022. Twenty-six patients aged 12 to 24 years with anterior open bite (0-4 mm) and SN-GoGn angles between 26 and 38 degrees, indicated for maxillary molar intrusion, were included.
All patients were treated with 0.018-inch slot Roth brackets. After leveling and alignment, a 0.016x0.022-inch stainless steel archwire was placed. Four self-drilling titanium mini-screws (diameter 1.8 mm) were inserted per patient: buccal mini-screws (8 mm) between the maxillary first and second molars and palatal mini-screws (10 mm) between the maxillary second premolar and first molar (paramedian palate in patients under 18 years). Insertion torque was 5-10 Ncm, controlled with a digital torque screwdriver. A 150 g intrusion force was applied immediately with elastic chains and reactivated every four weeks. In total, 104 mini-screws were placed (52 per group).
The right and left sides of each patient were randomly allocated by envelope method to ozonated olive oil spray or 0.2% chlorhexidine spray, each used as 10 sprays per day for 7 days. All patients were instructed to brush their teeth and the mini-screws three times daily.
Probing pocket depth, plaque index and bleeding index of the mini-screws and adjacent teeth (second premolar, first molar and second molar) were recorded. Tooth and mini-screw mobility were measured with a Periotest M device. Pain was assessed with a visual analog scale. All measurements were performed by the same clinician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized split-mouth design. In each patient, the right and left sides of the maxilla were randomly allocated by envelope method to ozonated olive oil spray or 0.2% chlorhexidine spray. Each side received one buccal and one palatal mini-screw for molar intrusion (52 mini-screws per group).
| Arm | Type | Receives |
|---|---|---|
| Ozonated Olive Oil | Experimental | Other: Ozonated Olive OilMini-screws and adjacent teeth on one randomly assigned side of the maxilla treated with ozonated olive oil spray (Arifoglu), 10 sprays per day for 7 days after mini-screw placement. |
| Chlorhexidine | Active comparator | Other: ChlorhexidineMini-screws and adjacent teeth on the contralateral side of the maxilla treated with 0.2% chlorhexidine gluconate oral spray (Kloroben), 10 sprays per day for 7 days after mini-screw placement. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age between 12 and 24 years
- Anterior open bite of 0-4 mm requiring fixed orthodontic treatment
- SN-GoGn angle between 26 and 38 degrees
- Indication for maxillary molar intrusion with mini-screws
- Willingness to comply with study instructions
Key exclusion criteria (5 listed)
- Systemic disease
- Medication use before or during the study
- Tobacco use
- Previous use of antimicrobial mouthwash
- Known allergy to the oral care products used
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 |
|---|---|---|
| Ozonated Olive OilOzonated olive oil oral spray (50 mL) applied to the mini-screw sites on the assigned side, 10 sprays per day for 7 days after mini-screw placement. | Other | Ozonated Olive Oil |
| Chlorhexidine0.2% chlorhexidine gluconate oral spray (Kloroben) applied to the mini-screw sites and adjacent teeth on the contralateral side of the maxilla, 10 sprays per day for 7 days after mini-screw placement. Serves as the active comparator in this split-mouth design. | Other | Chlorhexidine |
Primary outcome
Bleeding Index Around Mini-Screws
Time frame: Day 0 (mini-screw placement), day 7, day 14 and day 21
Bleeding index recorded around buccal and palatal mini-screws on the ozonated olive oil and chlorhexidine sides.
Plaque Index Around Mini-Screws
Time frame: Day 0 (mini-screw placement), day 7, day 14 and day 21
Plaque index recorded around buccal and palatal mini-screws on the ozonated olive oil and chlorhexidine sides.
Mini-Screw Mobility
Time frame: Day 0 (mini-screw placement), day 7, day 14 and day 21
Mini-screw mobility measured with Periotest M device (scale from -8 to +50; lower values indicate greater stability).
3 secondary outcomes
Probing Pocket Depth of Teeth Adjacent to Mini-Screws
Time frame: Baseline (before treatment), day 0, day 7, day 14 and day 21
Plaque and Bleeding Indices of Teeth Adjacent to Mini-Screws
Time frame: Baseline (before treatment), day 0, day 7, day 14 and day 21
Mobility of Teeth Adjacent to Mini-Screws
Time frame: Baseline (before treatment), day 0, day 7, day 14 and day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to participant privacy. De-identified data may be made available by the corresponding author upon reasonable request.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozonated Olive Oil and Chlorhexidine in people with Molar Intrusion and Ozonated Olive Oil, run by Yuzuncu Yil University at 2 sites in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding Index Around Mini-Screws (time frame: Day 0 (mini-screw placement), day 7, day 14 and day 21). 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 28 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.