Impacted Mandibular Third MolarNCT07895251
Chlorhexidine Gel After Wisdom Tooth Surgery: A Split-Mouth Randomized Trial
A study testing Chlorhexidine 0.2% Gel in people with Impacted Mandibular Third Molar and Postoperative Wound Healing, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This study evaluates whether placing 0.2% chlorhexidine gel into the tooth socket after lower wisdom tooth surgery improves gum healing, reduces bacteria on surgical stitches, and decreases postoperative pain, swelling, and difficulty opening the mouth. Participants require surgical removal of both lower wisdom teeth. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Impacted Mandibular Third Molar, Postoperative Wound Healing, Postoperative Pain
- What is being tested?
- Chlorhexidine 0.2% Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Oct 2025to 1 Jun 2026
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring surgical removal of bilateral impacted mandibular third molars.
- No acute inflammation or infection in either mandibular third molar region at enrollment.
- Provision of informed consent to participate in the study.
Who cannot join
- Contraindications to surgical tooth removal.
- Use of antibiotics or anti-inflammatory medications that could affect wound healing.
- Coagulation disorders.
- Known allergy to the local anesthetic used in the study.
- Pregnancy or breastfeeding.
- Suspected cystic lesions associated with either mandibular third molar.
- An adjacent second molar that does not meet the study eligibility requirements.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
University of Medicine and Pharmacy at Ho Chi Minh city
Ho Chi Minh City
About this study
Official title: EFFECTS OF CHLORHEXIDINE GEL ON SOFT TISSUE HEALING AND BACTERIAL LOAD AFTER SURGICAL REMOVAL OF IMPACTED MANDIBULAR THIRD MOLARS
This study evaluates whether placing 0.2% chlorhexidine gel into the tooth socket after lower wisdom tooth surgery improves gum healing, reduces bacteria on surgical stitches, and decreases postoperative pain, swelling, and difficulty opening the mouth.
Participants require surgical removal of both lower wisdom teeth. Each participant receives both treatments in separate operations at least four weeks apart. One side is randomly assigned to receive 1 mL of chlorhexidine gel before the wound is stitched closed. The other side receives no gel and serves as the comparison. Both sides receive the same standard postoperative care.
Pain and self-reported swelling are assessed on days 1, 3, and 7 after each operation. Facial swelling, mouth opening, and gum healing are assessed on days 3 and 7. A small sample of the surgical stitch is collected on day 7 to measure bacterial growth. Participants are also monitored for dry socket during the seven-day follow-up period.
Read the detailed description
This single-center, randomized, controlled, split-mouth clinical trial compares a single application of 0.2% chlorhexidine gel with no gel after surgical removal of bilateral impacted mandibular third molars. The study is conducted at the Dental Clinic of Tien Giang General Hospital, Vietnam.
The intervention side is randomly assigned by drawing lots, with the contralateral side serving as the control. The same surgeon performs both operations using a standardized surgical protocol, with an interval of at least four weeks between procedures. After tooth removal, both sockets are curetted and irrigated with 0.9% saline. On the intervention side, 1 mL of 0.2% chlorhexidine gel is placed into the socket immediately before closure with 3-0 silk sutures. No gel is applied on the control side. Postoperative medications and care instructions are standardized for both procedures.
Postoperative assessments include patient-reported pain and swelling, changes from baseline in facial measurements and maximum mouth opening, and soft tissue healing. Healing is assessed using the Early Healing Score, which evaluates clinical signs of re-epithelialization, hemostasis, and inflammation. Total scores range from 0 to 10, with higher scores indicating more favorable healing.
For microbiological assessment, a 5-mm segment from the second suture knot is collected on postoperative day 7 and placed in 2 mL of sterile saline. The suspension is agitated, serially diluted, and cultured on blood agar. Colonies are counted after 48 hours, and bacterial density is calculated as colony-forming units per milliliter of the original suspension.
The analysis accounts for the paired, within-participant design. Repeated clinical outcomes are analyzed using linear mixed-effects models, with adjustment for comparisons across assessment time points.
- Conditions
- Impacted Mandibular Third Molar, Postoperative Wound Healing, Postoperative Pain, Postoperative Swelling
- Being tested
- Chlorhexidine 0.2% Gel
- Keywords
- Chlorhexidine gel, Bacterial load, Suture colonization
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine 0.2% GelOther
1 mL of 0.2% chlorhexidine gel is applied locally into the extraction socket immediately after tooth removal, curettage, and saline irrigation, before suturing. No repeat application is performed.
| Study group | Role | What they receive |
|---|---|---|
| CHX | Experimental | The randomly assigned study side receives a single application of 1 mL of 0.2% chlorhexidine gel into the extraction socket immediately after surgical removal of the impacted mandibular third molar and before closure with 3-0 silk sutures. Standard postoperative medications and care instructions are provided. Receives: Other: Chlorhexidine 0.2% Gel |
| Control | No intervention | The contralateral side undergoes surgical removal of the impacted mandibular third molar without application of gel into the extraction socket. The socket is curetted, irrigated with 0.9% saline, and closed with 3-0 silk sutures. The same standard postoperative medications and care instructions are provided. The two operations are performed at least four weeks apart. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft Tissue Healing
Soft tissue healing at each surgical site is assessed using the Early Healing Score (EHS), comprising clinical signs of re-epithelialization, hemostasis, and inflammation. The total score ranges from 0 to 10, with higher scores indicating more favorable healing. Scores are compared between chlorhexidine-treated and control sites within each participant.
Measured: Postoperative days 3 and 7 after each surgery.
Bacterial load
A 5-mm segment from the second suture knot at each surgical site is collected and placed in 2 mL of sterile saline. Following agitation and dilution, the suspension is plated on blood agar, and colonies are counted after 48 hours of incubation. Bacterial density in the original suspension is expressed as colony-forming units per milliliter (CFU/mL). Lower values indicate a lower culturable bacterial load.
Measured: Suture sampling on postoperative day 7 after each surgery.
Secondary outcomes (4)
Postoperative Pain
Participants rate pain at each surgical site using a scale ranging from 0 to 5, with higher scores indicating greater pain severity.
Measured: Postoperative days 1, 3, and 7 after each surgery.
Patient-Reported Swelling
Participants rate swelling on the operated side using a scale ranging from 0 to 5, with higher scores indicating greater swelling severity.
Measured: Postoperative days 1, 3, and 7 after each surgery.
Facial Swelling
Facial swelling is assessed using three extraoral distances designated AB, CD, and CE. For each distance, swelling is calculated as the postoperative measurement minus the preoperative measurement and expressed in millimeters. Greater positive changes indicate greater swelling.
Measured: Baseline before each surgery and postoperative days 3 and 7.
Trismus
Maximum mouth opening is measured as the maximum interincisal distance in millimeters. Trismus is calculated as the preoperative distance minus the postoperative distance. Higher positive values indicate greater limitation of mouth opening.
Measured: Baseline before each surgery and postoperative days 3 and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Oct 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
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.
- 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
- Model description
- split-mouth design
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lam Cu Phong, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895251
- Sponsor's protocol ID
- CHX
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be available upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF CHLORHEXIDINE GEL ON SOFT TISSUE HEALING AND BACTERIAL LOAD AFTER SURGICAL REMOVAL OF IMPACTED MANDIBULAR THIRD MOLARS
- ClinicalTrials.gov ID
- NCT07895251
- Acronym / sponsor ID
- CHX
- Conditions
- Impacted Mandibular Third Molar, Postoperative Wound Healing, Postoperative Pain, Postoperative Swelling
- Keywords
- Chlorhexidine gel, Bacterial load, Suture colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 26 Oct 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 evaluates whether placing 0.2% chlorhexidine gel into the tooth socket after lower wisdom tooth surgery improves gum healing, reduces bacteria on surgical stitches, and decreases postoperative pain, swelling, and difficulty opening the mouth.
Participants require surgical removal of both lower wisdom teeth. Each participant receives both treatments in separate operations at least four weeks apart. One side is randomly assigned to receive 1 mL of chlorhexidine gel before the wound is stitched closed. The other side receives no gel and serves as the comparison. Both sides receive the same standard postoperative care.
Pain and self-reported swelling are assessed on days 1, 3, and 7 after each operation. Facial swelling, mouth opening, and gum healing are assessed on days 3 and 7. A small sample of the surgical stitch is collected on day 7 to measure bacterial growth. Participants are also monitored for dry socket during the seven-day follow-up period.
Detailed description
This single-center, randomized, controlled, split-mouth clinical trial compares a single application of 0.2% chlorhexidine gel with no gel after surgical removal of bilateral impacted mandibular third molars. The study is conducted at the Dental Clinic of Tien Giang General Hospital, Vietnam.
The intervention side is randomly assigned by drawing lots, with the contralateral side serving as the control. The same surgeon performs both operations using a standardized surgical protocol, with an interval of at least four weeks between procedures. After tooth removal, both sockets are curetted and irrigated with 0.9% saline. On the intervention side, 1 mL of 0.2% chlorhexidine gel is placed into the socket immediately before closure with 3-0 silk sutures. No gel is applied on the control side. Postoperative medications and care instructions are standardized for both procedures.
Postoperative assessments include patient-reported pain and swelling, changes from baseline in facial measurements and maximum mouth opening, and soft tissue healing. Healing is assessed using the Early Healing Score, which evaluates clinical signs of re-epithelialization, hemostasis, and inflammation. Total scores range from 0 to 10, with higher scores indicating more favorable healing.
For microbiological assessment, a 5-mm segment from the second suture knot is collected on postoperative day 7 and placed in 2 mL of sterile saline. The suspension is agitated, serially diluted, and cultured on blood agar. Colonies are counted after 48 hours, and bacterial density is calculated as colony-forming units per milliliter of the original suspension.
The analysis accounts for the paired, within-participant design. Repeated clinical outcomes are analyzed using linear mixed-effects models, with adjustment for comparisons across assessment time points.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- split-mouth design
| Arm | Type | Receives |
|---|---|---|
| CHX | Experimental | Other: Chlorhexidine 0.2% GelThe randomly assigned study side receives a single application of 1 mL of 0.2% chlorhexidine gel into the extraction socket immediately after surgical removal of the impacted mandibular third molar and before closure with 3-0 silk sutures. Standard postoperative medications and care instructions are provided. |
| Control | No intervention | –The contralateral side undergoes surgical removal of the impacted mandibular third molar without application of gel into the extraction socket. The socket is curetted, irrigated with 0.9% saline, and closed with 3-0 silk sutures. The same standard postoperative medications and care instructions are provided. The two operations are performed at least four weeks apart. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring surgical removal of bilateral impacted mandibular third molars.
- No acute inflammation or infection in either mandibular third molar region at enrollment.
- Provision of informed consent to participate in the study.
Key exclusion criteria (7 listed)
- Contraindications to surgical tooth removal.
- Use of antibiotics or anti-inflammatory medications that could affect wound healing.
- Coagulation disorders.
- Known allergy to the local anesthetic used in the study.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Chlorhexidine 0.2% Gel1 mL of 0.2% chlorhexidine gel is applied locally into the extraction socket immediately after tooth removal, curettage, and saline irrigation, before suturing. No repeat application is performed. | Other | CHX |
Primary outcome
Soft Tissue Healing
Time frame: Postoperative days 3 and 7 after each surgery.
Soft tissue healing at each surgical site is assessed using the Early Healing Score (EHS), comprising clinical signs of re-epithelialization, hemostasis, and inflammation. The total score ranges from 0 to 10, with higher scores indicating more favorable healing. Scores are compared between chlorhexidine-treated and control sites within each participant.
Bacterial load
Time frame: Suture sampling on postoperative day 7 after each surgery.
A 5-mm segment from the second suture knot at each surgical site is collected and placed in 2 mL of sterile saline. Following agitation and dilution, the suspension is plated on blood agar, and colonies are counted after 48 hours of incubation. Bacterial density in the original suspension is expressed as colony-forming units per milliliter (CFU/mL). Lower values indicate a lower culturable bacterial load.
4 secondary outcomes
Postoperative Pain
Time frame: Postoperative days 1, 3, and 7 after each surgery.
Patient-Reported Swelling
Time frame: Postoperative days 1, 3, and 7 after each surgery.
Facial Swelling
Time frame: Baseline before each surgery and postoperative days 3 and 7.
Trismus
Time frame: Baseline before each surgery and postoperative days 3 and 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 26 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be available upon reasonable request to the corresponding author.
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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 Chlorhexidine 0.2% Gel in people with Impacted Mandibular Third Molar and Postoperative Wound Healing, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 7 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 26 Oct 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 Vietnam. 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?
Soft Tissue Healing (time frame: Postoperative days 3 and 7 after each surgery.). The study lists 2 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 26 Oct 2026.