Wisdom Tooth RemovalPhase 3NCT07317596
Comparing Methylprednisolone And Hyaluronic Acid To Reduce Wisdom Tooth Surgery Complications
A Phase 3 study testing Methyl Prednisolone (MP) and Hyaluronic Acid (HA) in people with Wisdom Tooth Removal and Post Operative Complications, run by Sana'a University at 1 site in Yemen.
Trial summary
The goal of this clinical trial is to assess and compare the effectiveness of methylprednisolone and hyaluronic acid (HA), alone and in combination, in managing post-operative complications following the surgical extraction of impacted mandibular third molars (wisdom teeth). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Wisdom Tooth Removal, Post Operative Complications, Hyaluronic Acid
- What is being tested?
- Methyl Prednisolone (MP) and Hyaluronic Acid (HA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteYemen
- Study dates
- 27 Jun 2024to 15 Jul 2026
- Phase
- Phase 3
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient medically healthy.
- Patient between the ages of 18 and 40
- Patient had impacted mandibular third molar indication for extraction( mesio angler full impaction)
- Patients who were cooperative, motivated, to attend the follow-up
Who cannot join
- Pregnant women, children, elderly (>40 years), physically and mentally challenged, terminally and seriously ill.
- Patients who had severe pericoronitis, concomitant carious and/or periodontal disease.
- Patient who had contraindications to the medicines or anesthetics.
- Uncooperative Patients who won't be able to maintain the follow up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Methylprednisolone and Hyaluronic Acid, Individually and in Combination, on Reducing Postoperative Complications After Mandibular Third Molar Extraction
The goal of this clinical trial is to assess and compare the effectiveness of methylprednisolone and hyaluronic acid (HA), alone and in combination, in managing post-operative complications following the surgical extraction of impacted mandibular third molars (wisdom teeth). It will also learn about the safety and side effects of these treatments.
The main questions it aims to answer are:
Read more
- How effectively does methylprednisolone reduce post-operative pain, swelling (edema), and limited mouth opening (trismus)?
- How effectively does hyaluronic acid reduce post-operative pain, swelling (edema), and limited mouth opening (trismus)?
- Is the combination of methylprednisolone and hyaluronic acid more effective than either treatment alone in controlling these post-operative complications?
- What complications (e.g., soft tissue issues, infection) do participants experience with each treatment group? Researchers will compare the effects of methylprednisolone (given intravenously before surgery), hyaluronic acid (placed in the tooth socket after extraction), and a combination of both, against a control group that receives standard care (saline irrigation) to see which treatment or combination is most effective.
Participants will be medically healthy adults between the ages of 18 and 40 who are undergoing the surgical extraction of a fully impacted mandibular third molar.
Participants will be randomly assigned to one of four groups:
- Group I (Control): Receive standard care (saline irrigation of the wound).
- Group II (Methylprednisolone): Receive a single 125 mg dose of methylprednisolone intravenously one hour before surgery.
- Group III (Hyaluronic Acid): Receive 2 ml of hyaluronic acid placed directly into the tooth socket after extraction.
- Group IV (Combination): Receive both the pre-operative methylprednisolone injection and the post-extraction hyaluronic acid in the socket.
All participants will receive standard post-operative care, including antibiotics and pain medication, and will be followed up periodically to monitor for complications such as soft tissue issues or infection.
Read the detailed description
The surgical extraction of impacted mandibular third molars is a common procedure in oral and maxillofacial surgery, frequently associated with considerable postoperative complications such as pain, facial edema, and limited mandibular movement (trismus). Minimizing these adverse effects is crucial for the success of surgical procedures and patient comfort.While various methods are used to reduce these sequelae, adverse effects still pose a major challenge. Corticosteroids, such as methylprednisolone sodium succinate, offer potent anti-inflammatory actions that inhibit vasodilatation and decrease cellular exudates, which helps in reducing postoperative edema and pain. Additionally, Hyaluronic Acid (HA), a biocompatible glycosaminoglycan, plays a critical role in soft tissue structure, demonstrating anti-inflammatory impacts during oral wound healing and supporting tissue integrity.This prospective randomized controlled clinical trial is designed to evaluate and compare the individual and synergistic effectiveness of intravenous methylprednisolone sodium succinate and local application of hyaluronic acid in controlling post-extraction complications. The study will strictly monitor and objectively evaluate clinical outcomes including facial swelling, pain intensity, mouth opening, wound healing, and total analgesic consumption over a 7-day postoperative follow-up period.
- Being tested
- Methyl Prednisolone (MP), Hyaluronic Acid (HA)
- Keywords
- Mandibular third molar, Surgical extraction, Complications, Efficacy, Hyaluronic acid, Methylprednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl Prednisolone (MP)Drug
Also called Methylprednisolone sodium succinate
Methylprednisolone sodium succinate is a synthetic glucocorticoid (corticosteroid) administered intravenously at a single dose of 125 mg one hour prior to the surgical extraction of the impacted mandibular third molar. The purpose of this intervention is to reduce the inflammatory response, thereby controlling post-operative complications such as pain, swelling (edema), and limited mouth opening (trismus).
Hyaluronic Acid (HA)Biological
Also called Sodium Hyaluronate
Hyaluronic acid (HA) is a naturally occurring glycosaminoglycan that is placed directly into the tooth socket after the surgical extraction of the impacted mandibular third molar. A volume of 2 ml of HA is applied before the surgical site is closed. This intervention is intended to promote tissue healing, reduce inflammation, and aid in the control of post-operative pain and swelling.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will receive neither hyaluronic acid nor methylprednisolone |
| Hyaluronic acid only | Experimental | Hyaluronic acid placement only Receives: Biological: Hyaluronic Acid (HA) |
| Methylprednisolone only | Experimental | Methylprednisolone injection only Receives: Drug: Methyl Prednisolone (MP) |
| Combination | Experimental | Methylprednisolone + Hyaluronic acid Receives: Drug: Methyl Prednisolone (MP); Biological: Hyaluronic Acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Post-operative Complications (Pain, Swelling, and Trismus
Measured: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.
Secondary outcomes (3)
Change in Maximum Interincisal Opening (MIO)
Mean Change in Maximum Interincisal Opening (MIO) from Baseline to 7 Days Post-surgery.
Maximum Interincisal Opening (MIO) is defined as the maximum distance between the incisal edges of the upper and lower central incisors. Measurements will be recorded in millimeters (mm) using a standard surgical ruler. The reported value will be the mean change (decrease or recovery) from the pre-operative baseline measurement at each designated follow-up interval.
Unit of Measure: Millimeters (mm).
Measured: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours and 7 days post-surgery.
Change in Facial Swelling in Millimeters (Anthropometric Measurement).
Mean Change in Facial Swelling (Anthropometric Linear Measurements) Mean Change in Facial Swelling Based on the Sum of Two Linear Distances. Facial swelling is assessed using horizontal and vertical linear measurements between four reference points.
Facial swelling will be objectively assessed using standardized anthropometric linear measurements (in mm) with a flexible tape or ruler. The total swelling value is calculated as the sum of two distances:
From the angle of the mouth (Labial Commissure) to the tragus of the ear. From the external canthus of the eye to the angle of the mandible (Gonion). The reported data will be the mean change in the sum of these two distances compared to the pre-operative baseline.
Unit of Measure: Millimeters (mm).
Measured: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery
Incidence of Post-operative Adverse Events.
Number of Participants with Post-operative Adverse Events. This outcome measures the safety and tolerability of the treatment by recording the number of participants who experience any post-operative complications. Adverse events include, but are not limited to: surgical site infection, alveolar osteitis (dry socket), soft tissue dehiscence.
Unit of Measure: Number of Participants (Count).
Measured: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start27 Jun 2024
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wisdom Tooth RemovalStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Yahya Mohammed Al-Eryani, Sana'a University
- Investigators
- Amal Y Al-Eryani, Principal investigator, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317596
- Sponsor's protocol ID
- 742
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blondeau F, Daniel NG. Extraction of impacted mandibular third molars: postoperative complications and their risk factors. J Can Dent Assoc. 2007 May;73(4):325.
PubMed 17484797Altaweel AA, Gaber AE, Alnaffar MZ, Alshomrani EA, Alrehaili RA, Alshaikh RA, Baeshin JN, Al-Akhdar ES. Methylprednisolone and Hyaluronic Acid versus Each Agent Alone to Control Complication of Impacted Wisdom Removal. Evid Based Complement Alternat Med. 2022 Mar 24;2022:1563513. doi: 10.1155/2022/1563513. eCollection 2022.
PubMed 35368756Alenazi A, Alqhtani NR, Alghannam SS, Alghanim AM, Alasmari M, Almalki S, Eid MK. Effect of Hyaluronic Acid on Socket Healing After Lower Impacted Third Molar Tooth Extraction in 40 Dental Patients. Med Sci Monit. 2024 Sep 16;30:e945386. doi: 10.12659/MSM.945386.
PubMed 39279207
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Methylprednisolone and Hyaluronic Acid, Individually and in Combination, on Reducing Postoperative Complications After Mandibular Third Molar Extraction
- ClinicalTrials.gov ID
- NCT07317596
- Acronym / sponsor ID
- 742
- Keywords
- Mandibular third molar, Surgical extraction, Complications, Efficacy, Hyaluronic acid, Methylprednisolone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 5 Jan 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.
The goal of this clinical trial is to assess and compare the effectiveness of methylprednisolone and hyaluronic acid (HA), alone and in combination, in managing post-operative complications following the surgical extraction of impacted mandibular third molars (wisdom teeth). It will also learn about the safety and side effects of these treatments.
The main questions it aims to answer are:
- How effectively does methylprednisolone reduce post-operative pain, swelling (edema), and limited mouth opening (trismus)?
- How effectively does hyaluronic acid reduce post-operative pain, swelling (edema), and limited mouth opening (trismus)?
- Is the combination of methylprednisolone and hyaluronic acid more effective than either treatment alone in controlling these post-operative complications?
- What complications (e.g., soft tissue issues, infection) do participants experience with each treatment group? Researchers will compare the effects of methylprednisolone (given intravenously before surgery), hyaluronic acid (placed in the tooth socket after extraction), and a combination of both, against a control group that receives standard care (saline irrigation) to see which treatment or combination is most effective.
Participants will be medically healthy adults between the ages of 18 and 40 who are undergoing the surgical extraction of a fully impacted mandibular third molar.
Participants will be randomly assigned to one of four groups:
- Group I (Control): Receive standard care (saline irrigation of the wound).
- Group II (Methylprednisolone): Receive a single 125 mg dose of methylprednisolone intravenously one hour before surgery.
- Group III (Hyaluronic Acid): Receive 2 ml of hyaluronic acid placed directly into the tooth socket after extraction.
- Group IV (Combination): Receive both the pre-operative methylprednisolone injection and the post-extraction hyaluronic acid in the socket.
All participants will receive standard post-operative care, including antibiotics and pain medication, and will be followed up periodically to monitor for complications such as soft tissue issues or infection.
Detailed description
The surgical extraction of impacted mandibular third molars is a common procedure in oral and maxillofacial surgery, frequently associated with considerable postoperative complications such as pain, facial edema, and limited mandibular movement (trismus). Minimizing these adverse effects is crucial for the success of surgical procedures and patient comfort.While various methods are used to reduce these sequelae, adverse effects still pose a major challenge. Corticosteroids, such as methylprednisolone sodium succinate, offer potent anti-inflammatory actions that inhibit vasodilatation and decrease cellular exudates, which helps in reducing postoperative edema and pain. Additionally, Hyaluronic Acid (HA), a biocompatible glycosaminoglycan, plays a critical role in soft tissue structure, demonstrating anti-inflammatory impacts during oral wound healing and supporting tissue integrity.This prospective randomized controlled clinical trial is designed to evaluate and compare the individual and synergistic effectiveness of intravenous methylprednisolone sodium succinate and local application of hyaluronic acid in controlling post-extraction complications. The study will strictly monitor and objectively evaluate clinical outcomes including facial swelling, pain intensity, mouth opening, wound healing, and total analgesic consumption over a 7-day postoperative follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will receive neither hyaluronic acid nor methylprednisolone |
| Hyaluronic acid only | Experimental | Biological: Hyaluronic Acid (HA)Hyaluronic acid placement only |
| Methylprednisolone only | Experimental | Drug: Methyl Prednisolone (MP)Methylprednisolone injection only |
| Combination | Experimental | Drug: Methyl Prednisolone (MP), Biological: Hyaluronic Acid (HA)Methylprednisolone + Hyaluronic acid |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient medically healthy.
- Patient between the ages of 18 and 40
- Patient had impacted mandibular third molar indication for extraction( mesio angler full impaction)
- Patients who were cooperative, motivated, to attend the follow-up
Key exclusion criteria (4 listed)
- Pregnant women, children, elderly (>40 years), physically and mentally challenged, terminally and seriously ill.
- Patients who had severe pericoronitis, concomitant carious and/or periodontal disease.
- Patient who had contraindications to the medicines or anesthetics.
- Uncooperative Patients who won't be able to maintain the follow up visits.
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 |
|---|---|---|
| Methyl Prednisolone (MP)Also: Methylprednisolone sodium succinateMethylprednisolone sodium succinate is a synthetic glucocorticoid (corticosteroid) administered intravenously at a single dose of 125 mg one hour prior to the surgical extraction of the impacted mandibular third molar. The purpose of this intervention is to reduce the inflammatory response, thereby controlling post-operative complications such as pain, swelling (edema), and limited mouth opening (trismus). | Drug | Combination, Methylprednisolone only |
| Hyaluronic Acid (HA)Also: Sodium HyaluronateHyaluronic acid (HA) is a naturally occurring glycosaminoglycan that is placed directly into the tooth socket after the surgical extraction of the impacted mandibular third molar. A volume of 2 ml of HA is applied before the surgical site is closed. This intervention is intended to promote tissue healing, reduce inflammation, and aid in the control of post-operative pain and swelling. | Biological | Combination, Hyaluronic acid only |
Primary outcome
Comparison of Post-operative Complications (Pain, Swelling, and Trismus
Time frame: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.
3 secondary outcomes
Change in Maximum Interincisal Opening (MIO)
Time frame: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours and 7 days post-surgery.
Change in Facial Swelling in Millimeters (Anthropometric Measurement).
Time frame: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery
Incidence of Post-operative Adverse Events.
Time frame: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.
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 30 Apr 2026.
- Background: PubMed 17484797Blondeau F, Daniel NG. Extraction of impacted mandibular third molars: postoperative complications and their risk factors. J Can Dent Assoc. 2007 May;73(4):325.
- Background: PubMed 35368756Altaweel AA, Gaber AE, Alnaffar MZ, Alshomrani EA, Alrehaili RA, Alshaikh RA, Baeshin JN, Al-Akhdar ES. Methylprednisolone and Hyaluronic Acid versus Each Agent Alone to Control Complication of Impacted Wisdom Removal. Evid Based Complement Alternat Med. 2022 Mar 24;2022:1563513. doi: 10.1155/2022/1563513. eCollection 2022.
- Background: PubMed 39279207Alenazi A, Alqhtani NR, Alghannam SS, Alghanim AM, Alasmari M, Almalki S, Eid MK. Effect of Hyaluronic Acid on Socket Healing After Lower Impacted Third Molar Tooth Extraction in 40 Dental Patients. Med Sci Monit. 2024 Sep 16;30:e945386. doi: 10.12659/MSM.945386.
- Individual participant dataSharing planned: No
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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.
Amal Y Al-Eryani principal investigator
Sana'a University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methyl Prednisolone (MP) and Hyaluronic Acid (HA) in people with Wisdom Tooth Removal and Post Operative Complications, run by Sana'a University at 1 site in Yemen.
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 4 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: enrolling by invitation, as of the sponsor's last update on 30 Apr 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 Yemen. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Comparison of Post-operative Complications (Pain, Swelling, and Trismus (time frame: Baseline (pre-surgery) and at 24 hours, 48 hours, 72 hours, and 7 days post-surgery.). 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 NCT07317596, which also lists 3 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 30 Apr 2026.