An interventional study of Ozonated Olive Oil and Chlorhexidine in Molar Intrusion, Ozonated Olive Oil and Chlorhexidine, sponsored by Yuzuncu Yil University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 12 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Yuzuncu Yil University · Not applicable, Interventional, and Treatment
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:
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:
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.
34 studies on the registry are indexed under Open Bite; 8 are open to participants now.
This study's enrollment of 26 is below the median of 30 across 28 interventional studies indexed under Open Bite.
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Exclusion Criteria:
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.
Other: Ozonated Olive Oil
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.
Other: Chlorhexidine
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.
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.
Bleeding Index Around Mini-Screws
Bleeding index recorded around buccal and palatal mini-screws on the ozonated olive oil and chlorhexidine sides.
Time frame: 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.
Time frame: 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).
Time frame: Day 0 (mini-screw placement), day 7, day 14 and day 21
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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (before treatment), day 0, day 7, day 14 and day 21
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Feb 2022, 1 month.
Of 24 interventional studies with no phase under Open Bite, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Yuzuncu Yil University