Postoperative MorbidityNCT07853196
Effects of Hyaluronic Acid Complex and Dexamethasone on Pain, Swelling, and Trismus After Mandibular Third Molar Surgery
A study testing Hyaluronic Acid Complex, Dexamethasone and Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental) in people with Postoperative Morbidity, run by Cyprus Health and Social Sciences University at 1 site in Cyprus.
Trial summary
This study aimed to comparatively evaluate the effects of a hyaluronic acid complex and dexamethasone on postoperative pain, swelling, and trismus following mandibular third molar surgery, compared with a control group. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Postoperative Morbidity
- What is being tested?
- Hyaluronic Acid Complex, Dexamethasone and Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCyprus
- Study dates
- 5 Mar 2026to 25 Jul 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 35 years.
- No systemic disease.
- No regular medication use.
- Non-smoker.
- Not pregnant or lactating.
- Presence of an asymptomatic partially impacted mandibular third molar indicated for prophylactic surgical extraction.
Who cannot join
- Presence of acute pericoronitis.
- Presence of an abscess or acute odontogenic infection.
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
NEW Cyprus Health and Social Sciences University
Mórfou, Guzelyurt, 99750
About this study
Official title: Comparative Evaluation of the Effects of Hyaluronic Acid Complex and Dexamethasone on Postoperative Pain, Edema, and Trismus Following Mandibular Third Molar Surgery
This study aimed to comparatively evaluate the effects of a hyaluronic acid complex and dexamethasone on postoperative pain, swelling, and trismus following mandibular third molar surgery, compared with a control group. Participants were evaluated in three groups: a hyaluronic acid complex group, a dexamethasone group, and a control group. Postoperative pain, facial swelling, and limitation of mouth opening were assessed during the postoperative follow-up period to compare postoperative outcomes among the groups.
- Conditions
- Postoperative Morbidity
- Being tested
- Hyaluronic Acid Complex, Dexamethasone, Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental)
- Keywords
- Mandibular Third Molar Surgery, Dexamethasone, Postoperative Pain, Facial Swelling, Trismus, Hyaluronic Acid
- Medical subject headings
- Pain, Postoperative, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid ComplexDrug
Monovisc® (Anika Therapeutics, Inc., Bedford, MA, USA), containing 22 mg/mL cross-linked, high-molecular-weight sodium hyaluronate, was used. A 0.2 mL volume of the preparation (equivalent to 4.4 mg sodium hyaluronate) was applied directly into the extraction socket using a sterile applicator. SPONGOSTAN™ Dental absorbable hemostatic gelatin sponge was subsequently placed into the socket to enhance retention of the preparation.
DexamethasoneDrug
DEKORT® 8 mg/2 mL solution for I.M./I.V. injection (DEVA Holding A.Ş., Türkiye) was used. A 1.5 mL volume of the solution, corresponding to 6 mg dexamethasone, was absorbed into a SPONGOSTAN™ Dental absorbable hemostatic gelatin sponge and placed directly into the extraction socket.
Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental)Device
SPONGOSTAN™ Dental absorbable hemostatic gelatin sponge (MS0005; 1 × 1 × 1 cm; Ethicon, Johnson \& Johnson) was placed directly into the extraction socket. In the control group, the gelatin sponge was used without hyaluronic acid or dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Following mandibular third molar extraction, SPONGOSTAN™ Dental absorbable hemostatic gelatin sponge (MS0005; 1 × 1 × 1 cm; Ethicon, Johnson \& Johnson) was placed into the extraction socket. No hyaluronic acid complex or dexamethasone was administered. The surgical site was primarily closed with 3/0 silk sutures, which were removed on postoperative day 7. Receives: Device: Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental) |
| Hyaluronic Acid Complex Group | Experimental | Following mandibular third molar extraction, 0.2 mL of Monovisc® (22 mg/mL cross-linked high-molecular-weight sodium hyaluronate; Anika Therapeutics, Inc., Bedford, MA, USA), corresponding to 4.4 mg of sodium hyaluronate, was applied directly into the extraction socket. SPONGOSTAN™ Dental was subsequently placed to enhance retention within the socket. The surgical site was primarily closed with 3/0 silk sutures, which were removed on postoperative day 7. Receives: Drug: Hyaluronic Acid Complex; Device: Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental) |
| Dexamethasone Group | Experimental | Following mandibular third molar extraction, 1.5 mL of DEKORT® 8 mg/2 mL I.M./I.V. solution for injection (DEVA Holding A.Ş., Türkiye), corresponding to 6 mg of dexamethasone, was absorbed into SPONGOSTAN™ Dental and placed into the extraction socket. The surgical site was primarily closed with 3/0 silk sutures, which were removed on postoperative day 7. Receives: Drug: Dexamethasone; Device: Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Assessed Using the Visual Analog Scale (VAS)
Postoperative pain was assessed using a patient-reported Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicated no pain and 10 indicated unbearable/worst pain. Participants indicated their perceived pain intensity on the scale. No preoperative VAS measurement was performed
Measured: Postoperative days 1, 2, 3, and 7
Facial Swelling Assessed Using Facial Measurements
Facial swelling was assessed in millimeters (mm) using a flexible measuring tape. Three anatomical distances were measured: tragus to labial commissure, tragus to pogonion, and mandibular angle to lateral canthus. The arithmetic mean of the three measurements was calculated for each participant. Postoperative percentage change from the preoperative baseline was calculated as [(postoperative mean - preoperative mean) / |preoperative mean|] × 100. Positive values indicated an increase in facial measurements.
Measured: Preoperatively and on postoperative days 1, 2, 3, and 7
Trismus Assessed by Maximum Interincisal Mouth Opening
Trismus was assessed by measuring maximum interincisal mouth opening in millimeters (mm) using a digital caliper. The distance between the incisal edges of the maxillary and mandibular central incisors was measured once at each assessment. Postoperative percentage change from the preoperative baseline was calculated as [(postoperative value - preoperative value) / |preoperative value|] × 100. Negative values indicated a reduction in maximum mouth opening.
Measured: Preoperatively and on postoperative days 1, 2, 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 posted1 Oct 2026
- Study start5 Mar 2026
- Primary completion25 Jul 2026
- Study completion25 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative MorbidityStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus Health and Social Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadriye Yıldırım, Cyprus Health and Social Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853196
- Sponsor's protocol ID
- KSTU//2026/009
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 6 Oct 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, as no IPD sharing plan was established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Effects of Hyaluronic Acid Complex and Dexamethasone on Postoperative Pain, Edema, and Trismus Following Mandibular Third Molar Surgery
- ClinicalTrials.gov ID
- NCT07853196
- Acronym / sponsor ID
- KSTU//2026/009
- Conditions
- Postoperative Morbidity
- Keywords
- Mandibular Third Molar Surgery, Dexamethasone, Postoperative Pain, Facial Swelling, Trismus, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cyprus Health and Social Sciences UniversityUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 25 Jul 2026 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 1 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 aimed to comparatively evaluate the effects of a hyaluronic acid complex and dexamethasone on postoperative pain, swelling, and trismus following mandibular third molar surgery, compared with a control group. Participants were evaluated in three groups: a hyaluronic acid complex group, a dexamethasone group, and a control group. Postoperative pain, facial swelling, and limitation of mouth opening were assessed during the postoperative follow-up period to compare postoperative outcomes among the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental)Following mandibular third molar extraction, SPONGOSTAN™ Dental absorbable hemostatic gelatin sponge (MS0005; 1 × 1 × 1 cm; Ethicon, Johnson \& Johnson) was placed into the extraction socket. No hyaluronic acid complex or dexamethasone was administered. The surgical site was primarily closed with 3/0 silk sutures, which were removed on postoperative day 7. |
| Hyaluronic Acid Complex Group | Experimental | Drug: Hyaluronic Acid Complex, Device: Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental)Following mandibular third molar extraction, 0.2 mL of Monovisc® (22 mg/mL cross-linked high-molecular-weight sodium hyaluronate; Anika Therapeutics, Inc., Bedford, MA, USA), corresponding to 4.4 mg of sodium hyaluronate, was applied directly into the extraction socket. SPONGOSTAN™ Dental was subsequently placed to enhance retention within the socket. The surgical site was primarily closed with 3/0 silk sutures, which were removed on postoperative day 7. |
| Dexamethasone Group | Experimental | Drug: Dexamethasone, Device: Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental)Following mandibular third molar extraction, 1.5 mL of DEKORT® 8 mg/2 mL I.M./I.V. solution for injection (DEVA Holding A.Ş., Türkiye), corresponding to 6 mg of dexamethasone, was absorbed into SPONGOSTAN™ Dental and placed into the extraction socket. The surgical site was primarily closed with 3/0 silk sutures, which were removed on postoperative day 7. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 35 years.
- No systemic disease.
- No regular medication use.
- Non-smoker.
- Not pregnant or lactating.
Key exclusion criteria (2 listed)
- Presence of acute pericoronitis.
- Presence of an abscess or acute odontogenic infection.
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 |
|---|---|---|
| Hyaluronic Acid ComplexMonovisc® (Anika Therapeutics, Inc., Bedford, MA, USA), containing 22 mg/mL cross-linked, high-molecular-weight sodium hyaluronate, was used. A 0.2 mL volume of the preparation (equivalent to 4.4 mg sodium hyaluronate) was applied directly into the extraction socket using a sterile applicator. SPONGOSTAN™ Dental absorbable hemostatic gelatin sponge was subsequently placed into the socket to enhance retention of the preparation. | Drug | Hyaluronic Acid Complex Group |
| DexamethasoneDEKORT® 8 mg/2 mL solution for I.M./I.V. injection (DEVA Holding A.Ş., Türkiye) was used. A 1.5 mL volume of the solution, corresponding to 6 mg dexamethasone, was absorbed into a SPONGOSTAN™ Dental absorbable hemostatic gelatin sponge and placed directly into the extraction socket. | Drug | Dexamethasone Group |
| Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental)SPONGOSTAN™ Dental absorbable hemostatic gelatin sponge (MS0005; 1 × 1 × 1 cm; Ethicon, Johnson \& Johnson) was placed directly into the extraction socket. In the control group, the gelatin sponge was used without hyaluronic acid or dexamethasone. | Device | Control Group, Dexamethasone Group, Hyaluronic Acid Complex Group |
Primary outcome
Postoperative Pain Assessed Using the Visual Analog Scale (VAS)
Time frame: Postoperative days 1, 2, 3, and 7
Postoperative pain was assessed using a patient-reported Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicated no pain and 10 indicated unbearable/worst pain. Participants indicated their perceived pain intensity on the scale. No preoperative VAS measurement was performed
Facial Swelling Assessed Using Facial Measurements
Time frame: Preoperatively and on postoperative days 1, 2, 3, and 7
Facial swelling was assessed in millimeters (mm) using a flexible measuring tape. Three anatomical distances were measured: tragus to labial commissure, tragus to pogonion, and mandibular angle to lateral canthus. The arithmetic mean of the three measurements was calculated for each participant. Postoperative percentage change from the preoperative baseline was calculated as [(postoperative mean - preoperative mean) / |preoperative mean|] × 100. Positive values indicated an increase in facial measurements.
Trismus Assessed by Maximum Interincisal Mouth Opening
Time frame: Preoperatively and on postoperative days 1, 2, 3, and 7
Trismus was assessed by measuring maximum interincisal mouth opening in millimeters (mm) using a digital caliper. The distance between the incisal edges of the maxillary and mandibular central incisors was measured once at each assessment. Postoperative percentage change from the preoperative baseline was calculated as [(postoperative value - preoperative value) / |preoperative value|] × 100. Negative values indicated a reduction in maximum mouth opening.
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 6 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, as no IPD sharing plan was established for this study.
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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 Hyaluronic Acid Complex, Dexamethasone and Absorbable Hemostatic Gelatin Sponge (SPONGOSTAN™ Dental) in people with Postoperative Morbidity, run by Cyprus Health and Social Sciences University at 1 site in Cyprus.
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 2 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 6 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 Cyprus. 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 Assessed Using the Visual Analog Scale (VAS) (time frame: Postoperative days 1, 2, 3, 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?
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 6 Oct 2026.