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Third Molars ExtractionNCT07835958

Effects of Irrigation Solutions at Different Temperatures Used in Mandibular Third Molar Surgery

A study testing 4°C sterile saline solution, 25°C sterile saline solution and 4°C 0.2% chlorhexidine solution in people with Third Molars Extraction and Oral Health-Related Quality of Life, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The present study aims to compare the effects of saline, chlorhexidine, and hydrogen peroxide irrigation solutions at different temperatures on postoperative complications, including pain, swelling, and mouth opening, as well as oral health-related quality of life, in patients undergoing surgical extraction of… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
What is being tested?
4°C sterile saline solution, 25°C sterile saline solution and 4°C 0.2% chlorhexidine solution
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2026to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Presence of a unilateral or bilateral impacted mandibular third molar classified as Class II, Position B according to the Pell and Gregory classification), indicating that there is insufficient space in the jaw for eruption of the tooth and that the cervical line of the impacted tooth is at the level of the cervical line of the adjacent second molar.
  • Systemically healthy individuals classified as ASA Physical Status I.
  • Age between 18 and 35 years.
  • Willingness to participate in the study.

Who cannot join

  • Individuals outside the specified age range.
  • Pregnant individuals.
  • Individuals who are currently breastfeeding.
  • Presence of clinical signs of infection in the region of the impacted third molar, including acute pericoronitis.
  • Presence of any systemic disease that may affect wound healing, including metabolic, immunological, or endocrine disorders.
  • Presence of a cystic or tumoral lesion associated with the impacted third molar.
Show all 13Show fewer
  • History of allergy, hypersensitivity, or intolerance to chlorhexidine gluconate or hydrogen peroxide solutions to be used in the study.
  • Unwillingness to participate in the study.
  • Poor oral hygiene at a level that may adversely affect wound healing.
  • Cold intolerance or the presence or history of cold-related diseases, including Raynaud's disease, cold urticaria, or cryoglobulinemia.
  • Use of systemic antibiotics, corticosteroids, or nonsteroidal anti-inflammatory drugs (NSAIDs) within the previous two weeks.
  • Cases in which no bone removal is required during surgery.
  • Patients who meet the inclusion criteria but are unwilling to participate in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sara Samur Ergüven, DDS, PhD. Associate Professor contact

5334165005 ext. +90

sara.samur@sbu.edu.tr

Turkey (Türkiye)1 site
  • University of Health Sciences, Keciören, Ankara

    Ankara, 06610

Other trials in Turkey (Türkiye)

About this study

Official title: A Comparison of the Effects of Irrigation Solutions at Different Temperatures Used in Oral Surgery on Postoperative Complications and Oral Health-Related Quality of Life

The present study aims to compare the effects of saline, chlorhexidine, and hydrogen peroxide irrigation solutions at different temperatures on postoperative complications, including pain, swelling, and mouth opening, as well as oral health-related quality of life, in patients undergoing surgical extraction of impacted mandibular third molars. The irrigation solutions will be applied immediately following surgical tooth extraction at temperatures of either 4°C or 25°C.

An a prior power analysis based on repeated-measures analysis of variance (Repeated Measures ANOVA, within-between interaction) was performed. An effect size of f = 0.25, a Type I error rate (α = 0.05), and a statistical power of 1 - β = 0.95 were assumed.

Based on the power analysis, a minimum of 11 participants per group was determined to be sufficient. Considering potential loss to follow-up and missing data, the sample size was increased by approximately 15%, and it was decided to enroll 13 participants in each group. Accordingly, the planned study will be conducted with a total of 78 participants allocated to six groups, and all participants will be evaluated at four different time points.

Read the detailed description

The removal of mandibular third molars is among the most common procedures carried out in oral surgery. After extraction, patients often experience postoperative complications such as pain, swelling, and limited mouth opening. If these complications become more severe, they can negatively impact the patient's oral health-related quality of life.

In mandibular third molar surgery, following elevation of the soft tissue flap to gain access to the tooth, bone removal is performed using high-speed rotary instruments with continuous irrigation using physiological solutions . Following bone removal and exposure of the tooth, the extraction is performed. Subsequently, irrigation of the extraction socket with physiological saline or antiseptic solutions has been recommended. After socket irrigation and evaluation of the bony structures, the surgical site is sutured and postoperative instructions are provided to the patients.Although the aforementioned studies have demonstrated that socket irrigation may produce favorable postoperative outcomes, to the best of our knowledge, no study has evaluated the effectiveness of irrigation solutions used at different temperatures for socket irrigation.Therefore, the present study aims to compare the effects of saline, chlorhexidine, and hydrogen peroxide irrigation solutions at different temperatures on postoperative complications, including pain, swelling, and mouth opening, as well as oral health-related quality of life, in patients undergoing surgical extraction of impacted mandibular third molars. The irrigation solutions will be applied immediately following surgical tooth extraction at temperatures of either 4°C or 25°C.

The present study aims:

  1. To evaluate the effectiveness of 0.2% chlorhexidine gluconate and 1.5% hydrogen peroxide irrigation solutions at temperatures of 4°C or 25°C, compared with saline irrigation at the corresponding temperatures, on postoperative complications, including pain, mouth opening, and swelling, following mandibular third molar surgery.
  2. To evaluate the effectiveness of 0.2% chlorhexidine gluconate and 1.5% hydrogen peroxide irrigation solutions at temperatures of 4°C or 25°C, compared with saline irrigation at the corresponding temperatures, on oral health-related quality of life following mandibular third molar surgery.

Accordingly, the planned study will be conducted with a total of 78 participants allocated to six groups, and all participants will be evaluated at four different time points.

Being tested
4°C sterile saline solution, 25°C sterile saline solution, 4°C 0.2% chlorhexidine solution, 25°C 0.2% chlorhexidine solution, 4°C 1.5% hydrogen peroxide solution
Keywords
third molar extraction, oral health related quality of life, postoperative complications in maxillofacial surgery, irrigation solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4°C sterile saline solutionProcedure or surgery

    Patients whose extraction sockets will be irrigated with 4°C sterile saline solution following mandibular third molar surgery.

  • 25°C sterile saline solutionProcedure or surgery

    Patients whose extraction sockets will be irrigated with 25°C sterile saline solution following mandibular third molar surgery.

  • 4°C 0.2% chlorhexidine solutionProcedure or surgery

    Patients whose extraction sockets will be irrigated with 4°C 0.2% chlorhexidine solution following mandibular third molar surgery.

  • 25°C 0.2% chlorhexidine solutionProcedure or surgery

    Patients whose extraction sockets will be irrigated with 25°C 0.2% chlorhexidine solution following mandibular third molar surgery.

  • 4°C 1.5% hydrogen peroxide solutionProcedure or surgery

    Patients whose extraction sockets will be irrigated with 4°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.

  • 25°C 1.5% hydrogen peroxide solutionProcedure or surgery

    Patients whose extraction sockets will be irrigated with 25°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.

Study groups in NCT07835958
Study groupRoleWhat they receive
4°C sterile saline solutionExperimentalPatients whose extraction sockets will be irrigated with 4°C sterile saline solution following mandibular third molar surgery.
Receives: Procedure: 4°C sterile saline solution
25°C sterile saline solutionExperimentalPatients whose extraction sockets will be irrigated with 25°C sterile saline solution
Receives: Procedure: 25°C sterile saline solution
4°C 0.2% chlorhexidine solutionExperimentalPatients whose extraction sockets will be irrigated with 4°C 0.2% chlorhexidine solution following mandibular third molar surgery.
Receives: Procedure: 4°C 0.2% chlorhexidine solution
25°C 0.2% chlorhexidine solutionExperimentalPatients whose extraction sockets will be irrigated with 25°C 0.2% chlorhexidine solution following mandibular third molar surgery.
Receives: Procedure: 25°C 0.2% chlorhexidine solution
4°C 1.5% hydrogen peroxide solutionExperimentalPatients whose extraction sockets will be irrigated with 4°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.
Receives: Procedure: 4°C 1.5% hydrogen peroxide solution
25°C 1.5% hydrogen peroxide solutionExperimentalPatients whose extraction sockets will be irrigated with 25°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.
Receives: Procedure: 25°C 1.5% hydrogen peroxide solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Edema (Swelling)

    Edema will be measured along five predetermined anatomical reference lines using a flexible millimeter ruler. Measurements will be recorded in millimeters.

    Measured: Preoperatively and on postoperative days 2, 4, and 7

  2. Postoperative Pain

    Postoperative pain will be assessed by Visual Analog Scale (VAS). The amount of analgesic required by each patient during the postoperative period will be recorded daily on the patient follow-up form.

    Measured: Preoperative and postoperative days 2, 4, and 7 using a 10-cm VAS.

  3. Trismus (Restriction of Mouth Opening)

    Maximum mouth opening will be measured in millimeters using a digital caliper.

    Measured: Preoperative day and postoperative days 2, 4, and 7

Secondary outcomes (1)
  1. Oral Health Related Quality of Life (QoL)

    The Oral Health Impact Profile-14 (OHIP-14), a validated and reliable instrument, will be used to evaluate changes in patients' daily comfort and oral health-related quality of life.

    Measured: Preoperatively and on postoperative days 2, 4, and 7.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

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
Group 1: Patients whose extraction sockets will be irrigated with 4°C sterile saline solution following mandibular third molar surgery. Group 2: Patients whose extraction sockets will be irrigated with 25°C sterile saline solution following mandibular third molar surgery. Group 3: Patients whose extraction sockets will be irrigated with 4°C 0.2% chlorhexidine solution following mandibular third molar surgery. Group 4: Patients whose extraction sockets will be irrigated with 25°C 0.2% chlorhexidine solution following mandibular third molar surgery. Group 5: Patients whose extraction sockets will be irrigated with 4°C 1.5% hydrogen peroxide solution following mandibular third molar surgery. Group 6: Patients whose extraction sockets will be irrigated with 25°C 1.5% hydrogen peroxide solution following mandibular third molar surgery. In the present study all patients will be systemically healthy individuals classified as ASA Physical Status I, between 18 and 35 years.
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07835958
Sponsor's protocol ID
2026-300
Other IDs
Academician
Status last verified
Sep 2026
First submitted
17 Sep 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sifuentes-Cervantes JS, Carrillo-Morales F, Castro-Nunez J, Cunningham LL, Van Sickels JE. Third molar surgery: Past, present, and the future. Oral Surg Oral Med Oral Pathol Oral Radiol. 2021 Nov;132(5):523-531. doi: 10.1016/j.oooo.2021.03.004. Epub 2021 Mar 14.

    PubMed 34030996
  • Canakci FG, Er N, Duygu G, Tanan Karaca G. Does Saline Irrigation at Different Temperatures Affect Pain, Edema, and Trismus After Impacted Third Molar Surgery: A Clinical Trial. J Oral Maxillofac Surg. 2023 Jan;81(1):88-94. doi: 10.1016/j.joms.2022.08.015. Epub 2022 Aug 29.

    PubMed 36116545
  • Shahraki M, Khazaei AH, Hakimi S, Hasheminasab M, Haradasht SA. Effect of chlorhexidine, povidone-iodine, and hydrogen peroxide irrigation on pain and swelling after mandibular third molar surgery: randomized controlled trial. Int J Oral Maxillofac Surg. 2025 Jul;54(7):677-683. doi: 10.1016/j.ijom.2025.01.021. Epub 2025 Feb 14.

    PubMed 39952838
  • Brauer HU. Unusual complications associated with third molar surgery: a systematic review. Quintessence Int. 2009 Jul-Aug;40(7):565-72.

    PubMed 19626231

Questions about this trial

What is this clinical trial studying?

A study testing 4°C sterile saline solution, 25°C sterile saline solution and 4°C 0.2% chlorhexidine solution in people with Third Molars Extraction and Oral Health-Related Quality of Life, run by Saglik Bilimleri Universitesi 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 4 inclusion and 13 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: opening soon, as of the sponsor's last update on 23 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sara Samur Ergüven, DDS, PhD. Associate Professor (5334165005 ext. +90, sara.samur@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Edema (Swelling) (time frame: Preoperatively and on postoperative days 2, 4, and 7). 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?

On the ClinicalTrials.gov record for NCT07835958, which also lists 4 linked publications.

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 23 Sep 2026.

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