Impacted Mandibular Third MolarNCT07416136
The Aim of This Study is to Compare the Effects of Two Different Topical Agents (KLOROBEN® and KLORHEX PLUS®) Used in the Surgical Extraction of Mandibular Bilateral Mesioangular Impacted Third Molars on Postoperative Pain, Edema, and Trismus.
A study testing Kloroben topical spray and Klorhex Plus topical spray in people with Impacted Mandibular Third Molar, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effects of two commonly used topical mouth sprays on pain, swelling, and limitation of mouth opening after surgical removal of impacted lower wisdom teeth. A total of 40 adult patients who require the removal of both lower impacted wisdom teeth will participate in this study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Mandibular Third Molar
- What is being tested?
- Kloroben topical spray and Klorhex Plus topical spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2025to 19 Oct 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged between 18 and 50 years
- Indication for bilateral impacted mandibular third molar extraction
- ASA physical status I or II
- No antibiotic use within the previous two weeks
- No analgesic use within the previous 12 hours
- Ability to provide written informed consent
Who cannot join
- ASA physical status III to V
- Pregnancy or breastfeeding
- Known allergy to chlorhexidine, benzydamine, or flurbiprofen
- Smoking more than one pack per day
- History of substance abuse
- Presence of systemic diseases that may affect wound healing
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara Unıversity Faculty of Dentistry
Istanbul, Maltepe, 34840
About this study
Official title: Investigation of the Effects of Chlorhexidine Gluconate + Benzydamine Hydrochloride and Chlorhexidine Gluconate + Flurbiprofen on Pain, Edema, and Trismus Following Mandibular Impacted Third Molar Extraction
This study aims to compare the effects of two commonly used topical mouth sprays on pain, swelling, and limitation of mouth opening after surgical removal of impacted lower wisdom teeth.
A total of 40 adult patients who require the removal of both lower impacted wisdom teeth will participate in this study. Each patient will undergo two separate surgical procedures, with a healing period between them. After each surgery, one of the two topical agents will be applied to the surgical area. The order of the treatments will be randomly assigned.
Read more
The study is designed so that neither the patients nor the clinician evaluating the outcomes will know which topical agent is used at each session.
Pain levels, facial swelling, and mouth opening will be measured at specific time points after surgery. The results will help determine whether one topical treatment is more effective than the other in reducing postoperative discomfort and improving recovery.
The information obtained from this study may contribute to improving postoperative care following wisdom tooth surgery.
- Conditions
- Impacted Mandibular Third Molar
- Being tested
- Kloroben topical spray, Klorhex Plus topical spray
- Keywords
- wisdom tooth surgery, postoperative morbidity, chlorhexidine, benzydamine, flurbiprofen, split-mouth study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kloroben topical sprayDrug
Kloroben topical spray containing chlorhexidine gluconate and benzydamine hydrochloride is applied to the surgical site immediately after impacted mandibular third molar extraction and used postoperatively according to the study protocol to reduce pain, swelling, and trismus.
Klorhex Plus topical sprayDrug
Klorhex Plus topical spray containing chlorhexidine gluconate and flurbiprofen is applied to the surgical site immediately after impacted mandibular third molar extraction and used postoperatively according to the study protocol to reduce pain, swelling, and trismus.
| Study group | Role | What they receive |
|---|---|---|
| Kloroben Topical Spray Group | Experimental | Following surgical extraction of the impacted mandibular third molar, Kloroben topical spray containing chlorhexidine gluconate and benzydamine hydrochloride is applied to the surgical site. Patients use the spray postoperatively according to the study protocol, and postoperative pain, swelling, and trismus are evaluated. Receives: Drug: Klorhex Plus topical spray |
| Klorhex Plus Topical Spray Group | Active comparator | Following surgical extraction of the impacted mandibular third molar, Klorhex Plus topical spray containing chlorhexidine gluconate and flurbiprofen is applied to the surgical site. Patients use the spray postoperatively according to the study protocol, and postoperative pain, swelling, and trismus are evaluated. Receives: Drug: Kloroben topical spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity assessed by Visual Analog Scale (VAS)
Postoperative pain intensity assessed by the Visual Analog Scale (VAS, 0-10 cm), where 0 indicates no pain and 10 indicates worst imaginable pain; higher scores indicate greater pain intensity.
Measured: From 30 minutes to 168 hours after surgery
Postoperative facial swelling measurements
Postoperative facial swelling measured by linear facial distances (in centimeters) including tragus to pogonion, tragus to labial commissure, and mandibular angle to lateral canthus; higher values indicate greater swelling.
Measured: Preoperatively, postoperative day 2 and postoperative day 7
Maximum mouth opening (trismus assessment)
Trismus will be evaluated by measuring the maximum interincisal distance between the upper and lower central incisors using a ruler.
Measured: Preoperatively, postoperative day 2 and postoperative day 7
Secondary outcomes (1)
Postoperative analgesic consumption
The number of analgesic tablets consumed by each patient will be recorded daily following surgery.
Measured: From the day of surgery to postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start20 Apr 2025
- Primary completion15 Aug 2025
- Study completion19 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third MolarStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, double-blind, crossover (split-mouth) clinical trial. Each participant undergoes two separate surgical procedures for bilateral impacted mandibular third molar extraction. After each procedure, a different topical agent is applied in a randomized order, with a healing period between interventions. Outcomes are compared within the same participant to minimize inter-individual variability.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edip Eren Kadıkıran, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416136
- Sponsor's protocol ID
- 2015-KAEK-74-23-07
- Status last verified
- Mar 2026
- First submitted
- 8 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality, institutional policies, and local ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Chlorhexidine Gluconate + Benzydamine Hydrochloride and Chlorhexidine Gluconate + Flurbiprofen on Pain, Edema, and Trismus Following Mandibular Impacted Third Molar Extraction
- ClinicalTrials.gov ID
- NCT07416136
- Acronym / sponsor ID
- 2015-KAEK-74-23-07
- Conditions
- Impacted Mandibular Third Molar
- Keywords
- wisdom tooth surgery, postoperative morbidity, chlorhexidine, benzydamine, flurbiprofen, split-mouth study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 19 Oct 2025 (actual)
- First posted
- 17 Feb 2026 (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.
This study aims to compare the effects of two commonly used topical mouth sprays on pain, swelling, and limitation of mouth opening after surgical removal of impacted lower wisdom teeth.
A total of 40 adult patients who require the removal of both lower impacted wisdom teeth will participate in this study. Each patient will undergo two separate surgical procedures, with a healing period between them. After each surgery, one of the two topical agents will be applied to the surgical area. The order of the treatments will be randomly assigned.
The study is designed so that neither the patients nor the clinician evaluating the outcomes will know which topical agent is used at each session.
Pain levels, facial swelling, and mouth opening will be measured at specific time points after surgery. The results will help determine whether one topical treatment is more effective than the other in reducing postoperative discomfort and improving recovery.
The information obtained from this study may contribute to improving postoperative care following wisdom tooth surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, crossover (split-mouth) clinical trial. Each participant undergoes two separate surgical procedures for bilateral impacted mandibular third molar extraction. After each procedure, a different topical agent is applied in a randomized order, with a healing period between interventions. Outcomes are compared within the same participant to minimize inter-individual variability.
| Arm | Type | Receives |
|---|---|---|
| Kloroben Topical Spray Group | Experimental | Drug: Klorhex Plus topical sprayFollowing surgical extraction of the impacted mandibular third molar, Kloroben topical spray containing chlorhexidine gluconate and benzydamine hydrochloride is applied to the surgical site. Patients use the spray postoperatively according to the study protocol, and postoperative pain, swelling, and trismus are evaluated. |
| Klorhex Plus Topical Spray Group | Active comparator | Drug: Kloroben topical sprayFollowing surgical extraction of the impacted mandibular third molar, Klorhex Plus topical spray containing chlorhexidine gluconate and flurbiprofen is applied to the surgical site. Patients use the spray postoperatively according to the study protocol, and postoperative pain, swelling, and trismus are evaluated. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged between 18 and 50 years
- Indication for bilateral impacted mandibular third molar extraction
- ASA physical status I or II
- No antibiotic use within the previous two weeks
- No analgesic use within the previous 12 hours
Key exclusion criteria (6 listed)
- ASA physical status III to V
- Pregnancy or breastfeeding
- Known allergy to chlorhexidine, benzydamine, or flurbiprofen
- Smoking more than one pack per day
- History of substance abuse
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 |
|---|---|---|
| Kloroben topical sprayKloroben topical spray containing chlorhexidine gluconate and benzydamine hydrochloride is applied to the surgical site immediately after impacted mandibular third molar extraction and used postoperatively according to the study protocol to reduce pain, swelling, and trismus. | Drug | Klorhex Plus Topical Spray Group |
| Klorhex Plus topical sprayKlorhex Plus topical spray containing chlorhexidine gluconate and flurbiprofen is applied to the surgical site immediately after impacted mandibular third molar extraction and used postoperatively according to the study protocol to reduce pain, swelling, and trismus. | Drug | Kloroben Topical Spray Group |
Primary outcome
Postoperative pain intensity assessed by Visual Analog Scale (VAS)
Time frame: From 30 minutes to 168 hours after surgery
Postoperative pain intensity assessed by the Visual Analog Scale (VAS, 0-10 cm), where 0 indicates no pain and 10 indicates worst imaginable pain; higher scores indicate greater pain intensity.
Postoperative facial swelling measurements
Time frame: Preoperatively, postoperative day 2 and postoperative day 7
Postoperative facial swelling measured by linear facial distances (in centimeters) including tragus to pogonion, tragus to labial commissure, and mandibular angle to lateral canthus; higher values indicate greater swelling.
Maximum mouth opening (trismus assessment)
Time frame: Preoperatively, postoperative day 2 and postoperative day 7
Trismus will be evaluated by measuring the maximum interincisal distance between the upper and lower central incisors using a ruler.
1 secondary outcome
Postoperative analgesic consumption
Time frame: From the day of surgery to postoperative day 7
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 25 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality, institutional policies, and local ethical regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kloroben topical spray and Klorhex Plus topical spray in people with Impacted Mandibular Third Molar, run by Marmara 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 6 inclusion and 6 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 25 Mar 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?
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?
Postoperative pain intensity assessed by Visual Analog Scale (VAS) (time frame: From 30 minutes to 168 hours after surgery). 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?
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 25 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.