Skip to content

Ozonated Olive Oil for Mini-Screw Complications in Molar Intrusion

Effect of Ozonated Olive Oil on Mini-Screw Complications During Orthodontic Treatment Combined With Molar Intrusion

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07900022
Enrollment
26
Registered
2026-10-28
Start date
2021-12-20
Completion date
2022-04-25
Last updated
2026-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar Intrusion, Ozonated Olive Oil, Chlorhexidine

Keywords

molar intrusion, Open bite, Ozonated olive oil, Chlorhexidine, Orthodontic treatment

Brief 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. 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.

Interventions

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.

OTHERChlorhexidine

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.

Sponsors

Yuzuncu Yil University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
12 Years to 24 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Systemic disease * Medication use before or during the study * Tobacco use * Previous use of antimicrobial mouthwash * Known allergy to the oral care products used

Design outcomes

Primary

MeasureTime frameDescription
Bleeding Index Around Mini-ScrewsDay 0 (mini-screw placement), day 7, day 14 and day 21Bleeding index recorded around buccal and palatal mini-screws on the ozonated olive oil and chlorhexidine sides.
Plaque Index Around Mini-ScrewsDay 0 (mini-screw placement), day 7, day 14 and day 21Plaque index recorded around buccal and palatal mini-screws on the ozonated olive oil and chlorhexidine sides.
Mini-Screw MobilityDay 0 (mini-screw placement), day 7, day 14 and day 21Mini-screw mobility measured with Periotest M device (scale from -8 to +50; lower values indicate greater stability).

Secondary

MeasureTime frameDescription
Probing Pocket Depth of Teeth Adjacent to Mini-ScrewsBaseline (before treatment), day 0, day 7, day 14 and day 21Probing pocket depth (mm) of maxillary second premolar, first molar and second molar, calculated as the mean of buccal, palatal, mesial, distal and central sites.
Plaque and Bleeding Indices of Teeth Adjacent to Mini-ScrewsBaseline (before treatment), day 0, day 7, day 14 and day 21Plaque index and bleeding index of maxillary second premolar, first molar and second molar.
Mobility of Teeth Adjacent to Mini-ScrewsBaseline (before treatment), day 0, day 7, day 14 and day 21Tooth 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 29, 2026