PainNCT03428698
Hyaluronic Acid and Amino Acid Gel Applied to the Alveolar Socket After Mandibular Third Molar Extraction
A study testing Aminogam in people with Pain and Oral Surgery, run by University of Padova, School of Dental Medicine at 1 site in Italy.
Trial summary
Objective: The study aimed to assess the effect of topical application of an amino acid + sodium hyaluronate acid gel after lower third molar extraction. Study design: 136 patients requiring lower third molar extraction were enrolled. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Oral Surgery, Third Molar Extraction
- What is being tested?
- Aminogam
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteItaly
- Study dates
- 10 Sep 2009to 25 Nov 2011
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 between 25 years,
- ASA I or II,
- necessitating lower wisdom tooth extraction,
- no evidence of inflammation
Who cannot join
- smoking more than 10 cigarettes a day,
- pregnancy,
- uncontrolled diabetes mellitus,
- any diseases contraindicating the surgical procedure,
- use of bisphosphonate,
- antibiotics or NSAIDs during the 30 days preceding surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyaluronic Acid and Amino Acid Gel Applied to the Alveolar Socket After Mandibular Third Molar Extraction Promotes Wound Healing: a Double Blind Randomized Controlled Clinical Trial
Objective: The study aimed to assess the effect of topical application of an amino acid + sodium hyaluronate acid gel after lower third molar extraction.
Study design: 136 patients requiring lower third molar extraction were enrolled. An amino acid + sodium hyaluronate acid (HA) gel was applied to the sockets of the patients in the treatment group immediately following extraction; the sockets of the controls were simply flushed with a sterile saline solution. 7 and 14 days after surgery, patients' outcomes and postoperative complications were evaluated. Cumulative incidence of dehiscence and secondary outcome measures were analyzed using a chi-square test.
Read the detailed description
A lower third molar was extracted under local anesthesia generally involving an inferior alveolar nerve block associated with a buccal nerve block (2% mepivacaine with 1:100,000 epinephrine, Optocain, Molteni Dental, Italy), plus sedation as necessary. All the surgical tools and materials as well as the surgical field were sterile. A full-thickness flap was raised and, if necessary, osteotomy and tooth sectioning were performed using a straight handpiece with dedicated burs under copious irrigation with sterile saline solution. The extraction was completed with curved and straight extractors, the socket was closely inspected and the dental follicle was removed. The bone edges were refined to remove the bone spurs with a bone lime and then irrigated with abundant sterile 0.9% saline solution. Depending on the group to which the patient was assigned, one of the following procedures was carried out: the socket was filled with a topical amino acid + sodium hyaluronate gel (Aminogam®, sterile syringe 2 ml) or the socket was flushed, using a 2ml sterile syringe similar to one utilized to apply the gel, with sterile physiological solution. The flap was then repositioned and sutured (Novosyn 4.0, B. Braun AG, Melsungen, Germany) to allow healing by primary intention. After surgery, the patients were prescribed antibiotics (amoxicillin clavulanate 1 g every 12 hours for 6 days, or clarithromycin 250 mg every 12 hours for 6 days) and painkillers (paracetamol 1000 mg every 8 hours was recommended). The patients were also provided standard postoperative recommendations regarding activity, diet, and smoking. The following data were registered at the time of surgery: the range of pre-operative mouth opening measurement (assessed by measuring the distance between the incisors), the type of sedation utilized, if osteotomy or root resection was carried out, the quantity of peri-operative bleeding, the amount of time between incision and suture (surgical procedure time).
- Conditions
- Pain, Oral Surgery, Third Molar Extraction
- Being tested
- Aminogam
- Keywords
- third molar extraction, hyaluronic acid
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminogamDevice
A lower third molar was extracted. All the surgical tools and materials as well as the surgical field were sterile. A full-thickness flap was raised and, if necessary, osteotomy and tooth sectioning were performed using a straight handpiece with dedicated burs under copious irrigation with sterile saline solution. The extraction was completed with curved and straight extractors, the socket was closely inspected and the dental follicle was removed. Depending on the group to which the patient was assigned, one of the following procedures was carried out.
| Study group | Role | What they receive |
|---|---|---|
| experimental device | Experimental | The extraction was completed, the socket was filled with a topical amino acid + sodium hyaluronate gel (Aminogam®, sterile syringe 2 ml). Receives: Device: Aminogam |
| control no device | Placebo comparator | The extraction was completed, socket was flushed, using a 2ml sterile syringe similar to one utilized to apply the gel, with sterile physiological solution. Receives: Device: Aminogam |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative incidence of dehiscence
Surgical wound dehiscence is defined as a pathologic process consisting of a partial or complete disruption of the buccal and lingual mucosa layers of a surgical wound.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start10 Sep 2009
- Primary completion10 Sep 2010
- Study completion25 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova, School of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Sivolella, University of Padova, School of Dental Medicine
- Investigators
- Stefano Sivolella, DDS, PhD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428698
- Sponsor's protocol ID
- 1987/P
- Status last verified
- Feb 2018
- First submitted
- 4 Feb 2018
- Last updated
- 12 Feb 2018
- Results posted
- 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 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronic Acid and Amino Acid Gel Applied to the Alveolar Socket After Mandibular Third Molar Extraction Promotes Wound Healing: a Double Blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03428698
- Acronym / sponsor ID
- 1987/P
- Conditions
- Pain, Oral Surgery, Third Molar Extraction
- Keywords
- third molar extraction, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of Padova, School of Dental MedicineUniversity, hospital or other
- Study start
- 10 Sep 2009 (actual)
- Primary completion
- 10 Sep 2010 (actual)
- Study completion
- 25 Nov 2011 (actual)
- First posted
- 12 Feb 2018 (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.
Objective: The study aimed to assess the effect of topical application of an amino acid + sodium hyaluronate acid gel after lower third molar extraction.
Study design: 136 patients requiring lower third molar extraction were enrolled. An amino acid + sodium hyaluronate acid (HA) gel was applied to the sockets of the patients in the treatment group immediately following extraction; the sockets of the controls were simply flushed with a sterile saline solution. 7 and 14 days after surgery, patients' outcomes and postoperative complications were evaluated. Cumulative incidence of dehiscence and secondary outcome measures were analyzed using a chi-square test.
Detailed description
A lower third molar was extracted under local anesthesia generally involving an inferior alveolar nerve block associated with a buccal nerve block (2% mepivacaine with 1:100,000 epinephrine, Optocain, Molteni Dental, Italy), plus sedation as necessary. All the surgical tools and materials as well as the surgical field were sterile. A full-thickness flap was raised and, if necessary, osteotomy and tooth sectioning were performed using a straight handpiece with dedicated burs under copious irrigation with sterile saline solution. The extraction was completed with curved and straight extractors, the socket was closely inspected and the dental follicle was removed. The bone edges were refined to remove the bone spurs with a bone lime and then irrigated with abundant sterile 0.9% saline solution. Depending on the group to which the patient was assigned, one of the following procedures was carried out: the socket was filled with a topical amino acid + sodium hyaluronate gel (Aminogam®, sterile syringe 2 ml) or the socket was flushed, using a 2ml sterile syringe similar to one utilized to apply the gel, with sterile physiological solution. The flap was then repositioned and sutured (Novosyn 4.0, B. Braun AG, Melsungen, Germany) to allow healing by primary intention. After surgery, the patients were prescribed antibiotics (amoxicillin clavulanate 1 g every 12 hours for 6 days, or clarithromycin 250 mg every 12 hours for 6 days) and painkillers (paracetamol 1000 mg every 8 hours was recommended). The patients were also provided standard postoperative recommendations regarding activity, diet, and smoking. The following data were registered at the time of surgery: the range of pre-operative mouth opening measurement (assessed by measuring the distance between the incisors), the type of sedation utilized, if osteotomy or root resection was carried out, the quantity of peri-operative bleeding, the amount of time between incision and suture (surgical procedure time).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental device | Experimental | Device: AminogamThe extraction was completed, the socket was filled with a topical amino acid + sodium hyaluronate gel (Aminogam®, sterile syringe 2 ml). |
| control no device | Placebo comparator | Device: AminogamThe extraction was completed, socket was flushed, using a 2ml sterile syringe similar to one utilized to apply the gel, with sterile physiological solution. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18 between 25 years,
- ASA I or II,
- necessitating lower wisdom tooth extraction,
- no evidence of inflammation
Key exclusion criteria (6 listed)
- smoking more than 10 cigarettes a day,
- pregnancy,
- uncontrolled diabetes mellitus,
- any diseases contraindicating the surgical procedure,
- use of bisphosphonate,
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 |
|---|---|---|
| AminogamA lower third molar was extracted. All the surgical tools and materials as well as the surgical field were sterile. A full-thickness flap was raised and, if necessary, osteotomy and tooth sectioning were performed using a straight handpiece with dedicated burs under copious irrigation with sterile saline solution. The extraction was completed with curved and straight extractors, the socket was closely inspected and the dental follicle was removed. Depending on the group to which the patient was assigned, one of the following procedures was carried out. | Device | control no device, experimental device |
Primary outcome
cumulative incidence of dehiscence
Time frame: 14 days
Surgical wound dehiscence is defined as a pathologic process consisting of a partial or complete disruption of the buccal and lingual mucosa layers of a surgical wound.
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 12 Feb 2018.
- 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. This study is not recruiting at the moment.
Stefano Sivolella, DDS, PhD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aminogam in people with Pain and Oral Surgery, run by University of Padova, School of Dental Medicine at 1 site in Italy.
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 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 12 Feb 2018. 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 Italy. 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?
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?
cumulative incidence of dehiscence (time frame: 14 days). 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 12 Feb 2018.