Impacted Third Molar ToothNCT06020053
Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars
A study testing saline irrigation at various temperatures (4°C, 25°C) in people with Impacted Third Molar Tooth, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
An Evaluation of the Effect of Using Irrigations at Different Temperatures on Pain, Edema, and Trismus During the Extraction of Bilateral Impacted Mandibular Third Molars: A Randomized Split-Mouth Clinical Trial Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- saline irrigation at various temperatures (4°C, 25°C)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2021to 9 Jun 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18 to 30 who were classified as ASA (American Society of Anesthesiologists)1 and who required the removal of impacted third molars on either the right or left side of the mandible;
- Presence of impacted mandibular third molars on panoramic radiographs, bilaterally symmetrical, with bone retention and bone removal for extraction, position B class 2 of impacted teeth according to the Pell and Gregory Classification System, and mesioangular position according to the Winter Classification;
- Absence of systemic disease and habitual smoking behavior and absence of an allergy to the drugs to be used postoperatively.
Who cannot join
- Patients with a history of taking antibiotics and analgesics for at least one month;
- Having an infection in the operation area and acute pericoronitis or severe periodontal disease before the operation;
- The existence of cysts and tumors within proximity of the impacted third molar.
Trial locations and contacts
1 site in 1 country.
About this study
An Evaluation of the Effect of Using Irrigations at Different Temperatures on Pain, Edema, and Trismus During the Extraction of Bilateral Impacted Mandibular Third Molars: A Randomized Split-Mouth Clinical Trial
Read the detailed description
Abstract Introduction: The surgical extraction of impacted wisdom teeth is a standard practice in dentistry. Unfortunately, inflammatory reactions such as discomfort, edema, and trismus frequently jeopardize patients' well-being after the extraction of third molars. Saline solutions at room temperature (25°C) are routinely used in impacted tooth extraction. Refrigerated serums were used to work with cold serum, and since the refrigerator temperature was 4°C, this study was designed to have a cold serum temperature of 4°C. This study aims to assess the influence of saline irrigation at various temperatures (4°C, 25°C) on postoperative edema, pain, and trismus after the extraction of impacted third molars.
Materials and Methods: Eighteen patients with bilateral symmetrical mandibular impacted third molars were enrolled in this split-mouth, randomized, prospective, double-blind clinical trial. For each patient, one side was irrigated with a solution at 4°C (test), and the other side was irrigated with a solution at room temperature (25°C) (control). Pain, trismus, and facial edema were noted on the 2nd, 4th, and 7th days. A Mann-Whitney U-test was used to compare pairs, and a Wilcoxon signed-rank test was used to compare groups.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- saline irrigation at various temperatures (4°C, 25°C)
- Keywords
- irrigation,, third molar surgery,, temperature,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saline irrigation at various temperatures (4°C, 25°C)Procedure or surgery
cold serum application
| Study group | Role | What they receive |
|---|---|---|
| One of the symmetrical Impacted Mandibular Third Molars, control group | No intervention | Serum at room temperature (25°C) was applied to one of the mandibular impacted third molars |
| One of the symmetrical Impacted Mandibular Third Molars, intervention group | Experimental | Serum at temperature (4°C) was applied to one of the mandibular impacted third molars Receives: Procedure: saline irrigation at various temperatures (4°C, 25°C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain was noted on the 2nd, 4th, and 7th days.
Pain was evaluated with a 10-unit visual analog scale (VAS), which was included in the patient follow-up form on the postoperative second, fourth, and seventh days.
Measured: on the 2nd, 4th, and 7th days.
Secondary outcomes (2)
trismus was noted on the 2nd, 4th, and 7th days.
For trismus, preoperative and postoperative mouth openings were evaluated on the second, fourth, and seventh days by measuring the maximum distance between the incisal surface of the right maxillary incisor and the incisal surface of the right mandibular incisor with a caliper.
Measured: on the 2nd, 4th, and 7th days.
facial edema was noted on the 2nd, 4th, and 7th days
The level of facial edema was evaluated using Amin Laskin's protocol. Two measurements between four reference points were taken using a tape measure to assess facial edema. The distance between the tragus and the lip commissure and between the gonion and the lateral (outer) canthus of the eye were measured with a tape measure preoperatively and on the second, fourth, and seventh days after the operation.
Measured: on the 2nd, 4th, and 7th days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start2 Mar 2021
- Primary completion30 Jun 2021
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Dayanan, Firat University
- Investigators
- muhammet ozupek, Study director, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020053
- Sponsor's protocol ID
- FiratUniversitydentistry
- Status last verified
- Aug 2023
- First submitted
- 20 Jul 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars
- ClinicalTrials.gov ID
- NCT06020053
- Acronym / sponsor ID
- FiratUniversitydentistry
- Conditions
- Impacted Third Molar Tooth
- Keywords
- irrigation,, third molar surgery,, temperature,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 31 Aug 2023 (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.
An Evaluation of the Effect of Using Irrigations at Different Temperatures on Pain, Edema, and Trismus During the Extraction of Bilateral Impacted Mandibular Third Molars: A Randomized Split-Mouth Clinical Trial
Detailed description
Abstract Introduction: The surgical extraction of impacted wisdom teeth is a standard practice in dentistry. Unfortunately, inflammatory reactions such as discomfort, edema, and trismus frequently jeopardize patients' well-being after the extraction of third molars. Saline solutions at room temperature (25°C) are routinely used in impacted tooth extraction. Refrigerated serums were used to work with cold serum, and since the refrigerator temperature was 4°C, this study was designed to have a cold serum temperature of 4°C. This study aims to assess the influence of saline irrigation at various temperatures (4°C, 25°C) on postoperative edema, pain, and trismus after the extraction of impacted third molars.
Materials and Methods: Eighteen patients with bilateral symmetrical mandibular impacted third molars were enrolled in this split-mouth, randomized, prospective, double-blind clinical trial. For each patient, one side was irrigated with a solution at 4°C (test), and the other side was irrigated with a solution at room temperature (25°C) (control). Pain, trismus, and facial edema were noted on the 2nd, 4th, and 7th days. A Mann-Whitney U-test was used to compare pairs, and a Wilcoxon signed-rank test was used to compare groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One of the symmetrical Impacted Mandibular Third Molars, control group | No intervention | –Serum at room temperature (25°C) was applied to one of the mandibular impacted third molars |
| One of the symmetrical Impacted Mandibular Third Molars, intervention group | Experimental | Procedure: saline irrigation at various temperatures (4°C, 25°C)Serum at temperature (4°C) was applied to one of the mandibular impacted third molars |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 30 who were classified as ASA (American Society of Anesthesiologists)1 and who required the removal of impacted third molars on either the right or left side of the mandible;
- Presence of impacted mandibular third molars on panoramic radiographs, bilaterally symmetrical, with bone retention and bone removal for extraction, position B class 2 of impacted teeth according to the Pell and Gregory Classification System, and mesioangular position according to the Winter Classification;
- Absence of systemic disease and habitual smoking behavior and absence of an allergy to the drugs to be used postoperatively.
Key exclusion criteria (3 listed)
- Patients with a history of taking antibiotics and analgesics for at least one month;
- Having an infection in the operation area and acute pericoronitis or severe periodontal disease before the operation;
- The existence of cysts and tumors within proximity of the impacted third molar.
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 |
|---|---|---|
| saline irrigation at various temperatures (4°C, 25°C)cold serum application | Procedure or surgery | One of the symmetrical Impacted Mandibular Third Molars, intervention group |
Primary outcome
Pain was noted on the 2nd, 4th, and 7th days.
Time frame: on the 2nd, 4th, and 7th days.
Pain was evaluated with a 10-unit visual analog scale (VAS), which was included in the patient follow-up form on the postoperative second, fourth, and seventh days.
2 secondary outcomes
trismus was noted on the 2nd, 4th, and 7th days.
Time frame: on the 2nd, 4th, and 7th days.
facial edema was noted on the 2nd, 4th, and 7th days
Time frame: on the 2nd, 4th, and 7th days.
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 31 Aug 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
muhammet ozupek study director
Firat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saline irrigation at various temperatures (4°C, 25°C) in people with Impacted Third Molar Tooth, run by Firat University at 1 site 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 3 inclusion and 3 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 31 Aug 2023. 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 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?
Pain was noted on the 2nd, 4th, and 7th days. (time frame: on the 2nd, 4th, and 7th days.). 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 31 Aug 2023.