Dry SocketNCT07044219
The Effect of Chlorhexidine + Hyaluronic Acid on Postoperative Wound Healing After Lower Third Molar Removal
A study testing Third molar surgery in people with Dry Socket and Postoperative Infections, run by University of Pecs at 1 site in Hungary.
Trial summary
Our aim is to evaluate chlorhexidine-hyaluronic acid containing gel on postoperative wound healing regarding impacted lower third molar surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Socket, Postoperative Infections
- What is being tested?
- Third molar surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jul 2025to 1 Aug 2026
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients having lower impacted third molar
- impaction pattern Pell-Gregory II/A, III/A, I/B, II/B, III/B that means partially impacted, partially erupted teeth, where primary wound closure is usually not possible;
Who cannot join
- systemic disease (diabetes, steroids, antiresorptive therapy);
- allergy on gel's compounds;
- pregnancy;
- active or subacute local infection at third molar tooth (pericoronitis);
- poor oral hygiene (based on the presence of active caries and/or plaque index of 2-3)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Balázs Soós, PhD contact
Hungary1 site
Dept. of Oral and Maxillofacial Surgery, UP
Pécs, 7623
József Szalma, Prof, PhD, DSc, +3672502426, szalma.jozsef@pte.hu
About this study
Official title: The Effect of Chlorhexidine (0.5%) With Combination of Hyaluronic Acid on Postoperative Wound Healing After Lower Third Molar Removal: a Placebo Controlled Triple Blind Randomized Clinical Trial
Our aim is to evaluate chlorhexidine-hyaluronic acid containing gel on postoperative wound healing regarding impacted lower third molar surgery.
Read the detailed description
This is a triple-blind, placebo-controlled randomized clinical trial. Sixty patients will be randomly assigned to two treatment groups: Arm 1 receives Curasept DNA ADS periodontal gel during impacted third molar removal, while Arm 2 receives a placebo gel. Patient allocation uses an electronic randomization system with a 1:1 ratio. Baseline characteristics are recorded at the first clinical visit. The surgical procedure includes local anesthesia, mucoperiosteal flap elevation, bone removal with a surgical handpiece, and wound closure with non-resorbable sutures. Test gel or placebo is applied post-tooth removal, and patients are monitored postoperatively for pain, swelling, and wound healing, including follow-ups on the third, seventh and fourteenth days. Data analysis will use descriptive and statistical methods to evaluate efficacy.
- Conditions
- Dry Socket, Postoperative Infections
- Being tested
- Third molar surgery
- Keywords
- alveolitis, dry socket, dehiscence
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third molar surgeryProcedure or surgery
During the operation, after local anaesthetics (LIDOCAIN-ADRENALIN 20 mg/0,01 mg/ml) the same mucoperiosteal (sulcular flap without vertical incision) is raised. Bone removal happens with physio-dispenser driven surgical handpiece (60ml/min irrigation; 8.000-16.000 rpm) and tungsten carbide round drills. Tooth section is made where indicated. After tooth removal wound is rinsed with 10-20ml physiologic salt, the wound is closed with 4.0 monofil non-resorbable suture material and then gel test or placebo is injected with syringe and applicator tip into the wound and on the surface of the wound. Patient bites a gauze for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Curasept DNA ADS periodontal gel | Experimental | Not described Receives: Procedure: Third molar surgery |
| Placebo gel wound dressing | Placebo comparator | Not described Receives: Procedure: Third molar surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Scoring wound healing according to Inflammatory Proliferative Remodelling (IPR) Wound Healing Scale: 0-16: the smaller number indicates the poorer outcome
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (4)
Mouth opening
Measured: From enrollment to the end of treatment at 2 weeks
Subjective pain level
Visual Analogue Scale (VAS) 0-10: the higher number indicates the more intense pain.
Measured: From enrollment to the end of treatment at 2 weeks
Face swelling
Measured: From enrollment to the end of treatment at 2 weeks
Taken analgesics (questionaire)
Reported amount of taken analgesics: 400 mg ibuprofen in each 6 hours in the first 48 hours, and after that as needed, but maximum 400 mg ibuprofen/6 hours +/- 500 mg paracetamol/6 hours.
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SocketStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balazs Soos, University of Pecs
- Investigators
- József Szalma, Prof, PhD, DSc, Study director, UPMS Dept. Dentistry, Oral and Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044219
- Sponsor's protocol ID
- 7613-PTE 2019.
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 29 Jun 2025
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chlorhexidine (0.5%) With Combination of Hyaluronic Acid on Postoperative Wound Healing After Lower Third Molar Removal: a Placebo Controlled Triple Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07044219
- Acronym / sponsor ID
- 7613-PTE 2019.
- Conditions
- Dry Socket, Postoperative Infections
- Keywords
- alveolitis, dry socket, dehiscence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 29 Jun 2025 (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.
Our aim is to evaluate chlorhexidine-hyaluronic acid containing gel on postoperative wound healing regarding impacted lower third molar surgery.
Detailed description
This is a triple-blind, placebo-controlled randomized clinical trial. Sixty patients will be randomly assigned to two treatment groups: Arm 1 receives Curasept DNA ADS periodontal gel during impacted third molar removal, while Arm 2 receives a placebo gel. Patient allocation uses an electronic randomization system with a 1:1 ratio. Baseline characteristics are recorded at the first clinical visit. The surgical procedure includes local anesthesia, mucoperiosteal flap elevation, bone removal with a surgical handpiece, and wound closure with non-resorbable sutures. Test gel or placebo is applied post-tooth removal, and patients are monitored postoperatively for pain, swelling, and wound healing, including follow-ups on the third, seventh and fourteenth days. Data analysis will use descriptive and statistical methods to evaluate efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curasept DNA ADS periodontal gel | Experimental | Procedure: Third molar surgery |
| Placebo gel wound dressing | Placebo comparator | Procedure: Third molar surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients having lower impacted third molar
- impaction pattern Pell-Gregory II/A, III/A, I/B, II/B, III/B that means partially impacted, partially erupted teeth, where primary wound closure is usually not possible;
Key exclusion criteria (5 listed)
- systemic disease (diabetes, steroids, antiresorptive therapy);
- allergy on gel's compounds;
- pregnancy;
- active or subacute local infection at third molar tooth (pericoronitis);
- poor oral hygiene (based on the presence of active caries and/or plaque index of 2-3)
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 |
|---|---|---|
| Third molar surgeryDuring the operation, after local anaesthetics (LIDOCAIN-ADRENALIN 20 mg/0,01 mg/ml) the same mucoperiosteal (sulcular flap without vertical incision) is raised. Bone removal happens with physio-dispenser driven surgical handpiece (60ml/min irrigation; 8.000-16.000 rpm) and tungsten carbide round drills. Tooth section is made where indicated. After tooth removal wound is rinsed with 10-20ml physiologic salt, the wound is closed with 4.0 monofil non-resorbable suture material and then gel test or placebo is injected with syringe and applicator tip into the wound and on the surface of the wound. Patient bites a gauze for 20 minutes. | Procedure or surgery | Curasept DNA ADS periodontal gel, Placebo gel wound dressing |
Primary outcome
Wound healing
Time frame: From enrollment to the end of treatment at 2 weeks
Scoring wound healing according to Inflammatory Proliferative Remodelling (IPR) Wound Healing Scale: 0-16: the smaller number indicates the poorer outcome
4 secondary outcomes
Mouth opening
Time frame: From enrollment to the end of treatment at 2 weeks
Subjective pain level
Time frame: From enrollment to the end of treatment at 2 weeks
Face swelling
Time frame: From enrollment to the end of treatment at 2 weeks
Taken analgesics (questionaire)
Time frame: From enrollment to the end of treatment at 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Dry Socket
Recruiting
Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
Wound Healing, Alveolitis of Jaw
Not yet recruiting
Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis
Alveolar Osteitis
Not yet recruiting
Effectiveness of Telephonic and Digital Postoperative Follow-up Communication Strategies on Patient Compliance, Clinical Recovery, and Quality of Life After Dental Extraction
Tooth Extraction, Postoperative Care
RecruitingObservational study
PERIodontal Disease, Microbiota and Miscarriage
Miscarriage, Parodontitis
Active, not recruitingEarly Phase 1
Ozone Oil-based Gel and CHX Gel After Lower Third Molar Removal
Pain, Dry Socket
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.
Balázs Soós, PhD contact
József Szalma, Prof, PhD, DSc study director
UPMS Dept. Dentistry, Oral and Maxillofacial Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Third molar surgery in people with Dry Socket and Postoperative Infections, run by University of Pecs at 1 site in Hungary.
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 2 inclusion and 5 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 29 Jun 2025. 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 Hungary. 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. Some participants in this study may receive a placebo. 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 József Szalma, Prof, PhD, DSc (+3672502426, szalma.jozsef@pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: From enrollment to the end of treatment at 2 weeks). 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 29 Jun 2025.