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Effect of ozone gel on pain, swelling and limitation of mouth opening after wisdom tooth extractions in the same patient, one side using the gel and the other not

Effect of ozonized gel on the control of pain, edema and trismus in patients undergoing mandibular third molar extractions: a randomized split-mouth clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2dqd733
Enrollment
Unknown
Registered
2023-06-26
Start date
2023-07-21
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Molar, Third. Pain, Postoperative. Edema. Trismus

Interventions

This is a randomized, controlled, double-blind, split-mouth clinical trial. A total of 16 people who meet the eligibility criteria will be selected. The research will be carried out through extraction
proceeding with the surgical procedures until the end of the sample number. A stratified randomization will be performed using an Excel table. Surgical procedures on participants in the control group
E06.892
ozone

Sponsors

Faculdade de Ciências da Saúde da Universidade de Brasília - UnB
Lead Sponsor
Faculdade de Ciências da Saúde da Universidade de Brasília - UnB
Collaborator

Eligibility

Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: Volunteers of both sexes; age between 18 and 30 years; healthy; do not use any medication; having (radiographically evaluated) the two lower third molars in position B and class II of the Pell & Gregory Classification

Exclusion criteria

Exclusion criteria: Volunteer with systemic disease; pregnant; lactating woman; smoker; patient with an infectious process or tumor; person who presents incompatibility with standardized medication; patient who has and wishes to extract upper third molars (provided they are indicated) in the same surgical intervention; patient who wants to extract both lower third molars in the same session

Design outcomes

Primary

MeasureTime frame
It is expected to find less pain, edema and trismus in the postoperative period of extraction of the lower third molar where the ozonated gel was applied. The examining researcher will measure the swelling and mouth opening of the participants on days 0 (before surgery), 1, 3 and 7 (postoperative), and will compile the pain questionnaires. After surgery, participants will also receive a printed sheet containing the VAS Pain Scale consisting of 10 cm straight lines. Each line represents a time of the day, pain will be measured every two hours, starting at 8:00h and ending at 00:00h. The times when the participant is sleeping will be disregarded. The participant will mark their pain level, with the beginning of the line equaling “no pain” and the end of the line meaning “unbearable pain”. The amount of medication administered will also be noted on this sheet. At each return, the participant will deliver the sheet described above to the examining researcher and will receive a new sheet to fill in, with a total of 4 sheets filled out per participant. The edema will be measured by the examining researcher with a flexible measuring tape, and the measurements (in centimeters) will be recorded between the labial commissure and the tragus, between the labial commissure and the labial angle and between the corner of the eye and the mandibular angle. The mouth opening will be measured with the aid of a digital caliper

Secondary

MeasureTime frame
It is expected that the patient administers a smaller amount of medication in the postoperative period of extraction of the lower third molar where the ozonized gel was applied. The patient will record each medication intake. For this, the number of drugs administered on days 0 (before surgery), 1, 3 and 7 (postoperative) will be counted

Countries

Brazil

Contacts

Public ContactRaquel Pinheiro

Faculdade de Ciências da Saúde da Universidade de Brasília - UnB

meneghini.raquel@gmail.com+55(61)996358479

Outcome results

None listed

Source: REBEC (via WHO ICTRP)