Tooth, ImpactedNCT04869306
Effect of Hyaluronic Acid on Tissue Healing After Removal of Impacted Mandibular Third Molars (LM3)
A study testing Hyaluronic acid gel and Hyaluronic acid gel + carrier in people with Tooth, Impacted, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Hyaluronic acid (HY) is used in dentistry to improve wound healing after oral and periodontal surgical interventions. After the application of HY, a positive effect on the wound healing of extraction sockets and periodontal defects has been described. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tooth, Impacted
- What is being tested?
- Hyaluronic acid gel and Hyaluronic acid gel + carrier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteAustria
- Study dates
- 29 Nov 2021to 1 May 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients elder than 18 years;
- uni- or bilateral vertical or mesioangular complete impaction of the LM3 classified to:
- group II- or III- B or C according to Pell-Gregory (1933);
- a distance ≥ 5 mm from the CEJ to marginal bone level at the distal aspect of the second molar.
Who cannot join
- Patients with chronic diseases and/or
- taking any medication, influencing hard and soft tissue healing;
- acute pain/infection of the surgical region;
- untreated periodontal disease;
- patients smoking > 10 cigarettes per day;
- pregnancy;
Show all 10Show fewer
- history of hypersensitivity or allergy to HY;
- absence of an adjacent second molar;
- presence of caries or restoration on the distal aspect of the adjacent second molar; and
- inability to attend the follow-up appointments.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
University Clinic of Dentistry, Medical University of Vienna
Vienna, 1090
Danijel Domic, Dr.med.dent., +43(0)1400704121, danijel.domic@meduniwien.ac.at
Tobias Lang, Dr.med.dent., +43(0)1400704109, tobias.lang@meduniwien.ac.at
About this study
Official title: Effect of Hyaluronic Acid on Early and Late Tissue Healing After Removal of Impacted Mandibular Third Molars - A Double-blind, Randomized Controlled Clinical Trial
Hyaluronic acid (HY) is used in dentistry to improve wound healing after oral and periodontal surgical interventions. After the application of HY, a positive effect on the wound healing of extraction sockets and periodontal defects has been described. The removal of a mandibular wisdom tooth (LM3) often leads to remaining residual defects with increased probing depths distal to the second molar. To date, the influence of HY on periodontal healing of the distal aspect of the second molar after removal of the LM3 has not yet been investigated. Accordingly, the aim of this double-blind, controlled and randomized clinical study is the influence of the application of HY Gel or HY Gel in combination with an absorbable collagen sponge on the periodontal healing of the second molar after surgical removal of the LM3 compared to the standard procedure (blood clot). A total of 102 patients with an impacted LM3 and a pre-existing bone defect of at least 5 mm distal to the second molar will be included. In the HY test group (n = 34), HY gel is applied to the LM3 extraction socket, and in the HY + C test group (n = 34) HY gel and an absorbable collagen sponge, while the control group (n = 34) does not receive any additional treatment. Patients are followed up for 12 months and the presence of an increased probing depth (≥ 5mm) on the distal side of the second molar is defined as the main parameter. A more stable blood clot and thus improved wound healing including periodontal healing is expected through the use of HY.
- Conditions
- Tooth, Impacted
- Being tested
- Hyaluronic acid gel, Hyaluronic acid gel + carrier
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid gelDevice
After lower third molar removal, the test group 1 will additionally receive hyaluronic acid gel prior to wound closure.
Hyaluronic acid gel + carrierDevice
After lower third molar removal, the test group 2 will additionally receive hyaluronic acid gel with a collagen carrier prior to wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Active comparator | hyaluronic acid gel application after lower third molar removal Receives: Device: Hyaluronic acid gel |
| Hyaluronic acid+carrier | Active comparator | hyaluronic acid gel application together with a carrier after lower third molar removal Receives: Device: Hyaluronic acid gel + carrier |
| Standard treatment | No intervention | standard treatment after lower third molar removal (i.e., blood clot only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth at adjacent second molar
Probing depth will be measured from the gingival margin to the bottom of the periodontal pocket measured in mm with a graduated periodontal probe at disco-buccal, distal and disco-lingual aspect of the second molar
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start29 Nov 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth, ImpactedStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danijel Domic DMD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869306
- Sponsor's protocol ID
- 2244/2020
- Status last verified
- Aug 2022
- First submitted
- 16 Apr 2021
- Last updated
- 1 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyaluronic Acid on Early and Late Tissue Healing After Removal of Impacted Mandibular Third Molars - A Double-blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04869306
- Acronym / sponsor ID
- 2244/2020
- Conditions
- Tooth, Impacted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 3 May 2021 (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.
Hyaluronic acid (HY) is used in dentistry to improve wound healing after oral and periodontal surgical interventions. After the application of HY, a positive effect on the wound healing of extraction sockets and periodontal defects has been described. The removal of a mandibular wisdom tooth (LM3) often leads to remaining residual defects with increased probing depths distal to the second molar. To date, the influence of HY on periodontal healing of the distal aspect of the second molar after removal of the LM3 has not yet been investigated. Accordingly, the aim of this double-blind, controlled and randomized clinical study is the influence of the application of HY Gel or HY Gel in combination with an absorbable collagen sponge on the periodontal healing of the second molar after surgical removal of the LM3 compared to the standard procedure (blood clot). A total of 102 patients with an impacted LM3 and a pre-existing bone defect of at least 5 mm distal to the second molar will be included. In the HY test group (n = 34), HY gel is applied to the LM3 extraction socket, and in the HY + C test group (n = 34) HY gel and an absorbable collagen sponge, while the control group (n = 34) does not receive any additional treatment. Patients are followed up for 12 months and the presence of an increased probing depth (≥ 5mm) on the distal side of the second molar is defined as the main parameter. A more stable blood clot and thus improved wound healing including periodontal healing is expected through the use of HY.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Active comparator | Device: Hyaluronic acid gelhyaluronic acid gel application after lower third molar removal |
| Hyaluronic acid+carrier | Active comparator | Device: Hyaluronic acid gel + carrierhyaluronic acid gel application together with a carrier after lower third molar removal |
| Standard treatment | No intervention | –standard treatment after lower third molar removal (i.e., blood clot only) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients elder than 18 years;
- uni- or bilateral vertical or mesioangular complete impaction of the LM3 classified to:
- group II- or III- B or C according to Pell-Gregory (1933);
- a distance ≥ 5 mm from the CEJ to marginal bone level at the distal aspect of the second molar.
Key exclusion criteria (10 listed)
- Patients with chronic diseases and/or
- taking any medication, influencing hard and soft tissue healing;
- acute pain/infection of the surgical region;
- untreated periodontal disease;
- patients smoking > 10 cigarettes per day;
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 gelAfter lower third molar removal, the test group 1 will additionally receive hyaluronic acid gel prior to wound closure. | Device | Hyaluronic acid |
| Hyaluronic acid gel + carrierAfter lower third molar removal, the test group 2 will additionally receive hyaluronic acid gel with a collagen carrier prior to wound closure. | Device | Hyaluronic acid+carrier |
Primary outcome
Probing depth at adjacent second molar
Time frame: 1 year
Probing depth will be measured from the gingival margin to the bottom of the periodontal pocket measured in mm with a graduated periodontal probe at disco-buccal, distal and disco-lingual aspect of the second molar
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
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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.
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 gel and Hyaluronic acid gel + carrier in people with Tooth, Impacted, run by Medical University of Vienna at 1 site in Austria.
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 10 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: status not confirmed, as of the sponsor's last update on 1 Sep 2022. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danijel Domic, DMD (+4369917230592, Danijel.domic@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth at adjacent second molar (time frame: 1 year). 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 1 Sep 2022.