Molar, FourthNCT06458478
Effects of the Application of a Hyper-oxygenated Gel After Oral Surgery
A study testing Hyper-oxygenated gel and glycerin based gel in people with Molar, Fourth and Extracting Own Teeth, run by Azienda Ospedaliera di Perugia at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate whether the topical application of Novox® Drop on surgical wounds after the extraction of lower third molars can have a clinical advantage. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Molar, Fourth, Extracting Own Teeth, Edema Face
- What is being tested?
- Hyper-oxygenated gel and glycerin based gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2024to 1 Feb 2025
- 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
- good systemic and local health conditions of the patient;
- age between 18 and 35 years;
- understanding of the Italian language,
- indications for the extraction of impacted bilateral lower third molars (38 and 48) according to the criteria reported in the classifications of Winter and that of Pell and Gregory;
- the root of the impacted third molars is completely formed.
Who cannot join
- diabetes mellitus;
- systemic arterial hypertension;
- hyperthyroidism;
- osteoporosis;
- immunosuppressed;
- osteonecrosis of the jaws;
Show all 11Show fewer
- pregnancy;
- patients with mandibular third molars in position C according to "the Pell \& Gregory Classification" on the radiological measurements (angles and positions) for which third molar extraction surgery is required.;
- local alterations such as pericoronitis, odontogenic cysts and tumors in relation to the third molars;
- allergies;
- ordinary use of analgesics or antibiotics by the patient.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Santa Maria della Misericordia
Perugia, 06156
valeria mitro, dr, +393494509722, valeria.mitro@ospedale.perugia.it
massimiliano gilli, dr, +393200360473, massimiliano.gilli@ospedale.perugia.it
About this study
Official title: Effects of the Application of a Hyper-oxygenated Gel After Extraction of Impacted Lower Third Molars: Randomized Controlled Study
The goal of this clinical trial is to evaluate whether the topical application of Novox® Drop on surgical wounds after the extraction of lower third molars can have a clinical advantage.
The primary objective of the study is to evaluate the possible reduction of masseteric trismus (masticatory muscle spasm - primary outcome) and of post-operative pain and facial edema (swelling - secondary outcomes) after the extraction of impacted third molars compared to those who do not use it (placebo=glycerin-based gel).
Read the detailed description
Novox drop is a medical device (CE certified, class II b, non-invasive) based on oxygen-enriched olive oil (Excipients: Mint essential oil (2%), Stevia extract (1%)). Mechanism of action: facilitate the healing process by creating, thanks to the release of reactive oxygen species (ROS), a microenvironment favorable to the activation of the microcirculation and at the same time unfavorable to the proliferation of pathogens. Furthermore, it has a film-forming, protective, barrier and soothing action thanks to its oily nature.
The placebo consists of a viscous, colorless and transparent gel, based on glycerin (Conformity:FUI).
The company producing Novox Drop will package both gels in opaque disposable syringes, identical from each other and distinguishable only by the presence of an "A" or "B" code. During the phases of the study, only the company will be aware which of the two codes will be associated with the medical device and which will be associated with the placebo. The patients to be subjected to the study will be obtained from those arriving at the maxillofacial surgery clinics for the surgical extraction of complex lower third molars, starting from July 2024 until the necessary sample size of 72 participants is reached. Each of them, who will be assigned a sequential numerical code, will be placed randomly (randomized) in one of the two arms of the study itself, group A or group B, using the Excel Microsoft 2015 system.
Patients in group A, in addition to the standard antibiotic therapy (amoxicillin + clavulanic acid 1 g x 3 times a day x 7 days) and painkiller (paracetamol 1000 mg x 2 times a day x 7 days) will be prescribed the home use of syringe A. Patients in group B, in addition to the aforementioned traditional therapy, the syringe B. The gel prescribed in both groups must be applied to the post-extraction site 3 times a day for 7 days. Furthermore, after each application of the gels, the patient cannot consume drinks and solid foods for 30 minutes.
The duration of the study will be one week, and will be divided into three visits:
the first at time 0 as soon as the surgery is finished where all the hygiene recommendations will be made, the basic therapy drugs (antibiotic and anti-inflammatory) will be prescribed, and the gels will be prescribed in the A or B syringes; the second visit at time 1 three days after the operation and the third visit at time 2 after a week in which the patient's health status will be assessed, the study data will be collected, the blisters of the therapy performed will be collected and the hygiene advice will be reiterated .
For the administration method just described, the study will be a triple blind study, where neither the patient, nor the prescribing doctor nor the observer of the results of the surgical wounds will be aware of the type of gel used. Only the doctor responsible for cataloging and processing complete with the results you will be aware of which gel was contained in syringe A and which in syringe B.
- Conditions
- Molar, Fourth, Extracting Own Teeth, Edema Face, Pain, Trismus
- Being tested
- Hyper-oxygenated gel, glycerin based gel
- Keywords
- dysodontiasis, third molar, oral surgery, edema, trismus, pain
- Medical subject headings
- Tooth, Supernumerary, Pain, Trismus, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyper-oxygenated gelOther
Also called Novox drop
Novox drop is a medical device (CE certified, class II b, non-invasive) based on oxygen-enriched olive oil (Excipients: Mint essential oil (2%), Stevia extract (1%)). Mechanism of action: facilitate the healing process by creating, thanks to the release of reactive oxygen species (ROS), a microenvironment favorable to the activation of the microcirculation and at the same time unfavorable to the proliferation of pathogens. Furthermore, it has a film-forming, protective, barrier and soothing action thanks to its oily nature.
glycerin based gelOther
The placebo consists of a viscous, colorless and transparent gel, based on glycerin (Conformity:FUI).
| Study group | Role | What they receive |
|---|---|---|
| Hyper-oxygenated Gel | Active comparator | Patients undergoing lower third molar extraction. Post-operatively, the antibiotic (amoxicillin + clavulanic acid) and the painkiller (paracetamol 1000mg x 2 times a day x 7 days) are prescribed.
Furthermore, patients will have to use the Novox drop at the post-extraction site 3 times a day for 7 days (without taking liquids for 30 minutes after use). Receives: Other: Hyper-oxygenated gel |
| Placebo | Placebo comparator | Patients undergoing lower third molar extraction. Post-operatively, the antibiotic (amoxicillin + clavulanic acid) and the painkiller (paracetamol 1000 mg x 2 times a day x 7 days) are prescribed.
Furthermore, patients will have to use the Placebo, glycerin based gel, at the post-extraction site 3 times a day for 7 days (without taking liquids for 30 minutes after use). Receives: Other: glycerin based gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masseteric trismus.
Masseteric trismus will be assessed by measuring the width of the mouth opening. Precisely, the distance in cm between the mesial corners of the incisal edges of the upper central incisors and the lower right incisors at maximum mouth opening, before surgery and on the seventh postoperative day, using a caliper. Measurements will be taken twice to determine the average score. The difference between the average of each postoperative measurement and the preoperative one will indicate the trismus for that day.
Measured: seven days
Secondary outcomes (2)
Post-operative pain
The intensity of postoperative pain will be assessed with a Visual Analog Scale (VAS). The patient will be able to express the degree of pain perceived at both time one and time two on a scale of ten intervals. Grade 1 on the scale indicates no pain, grade ten indicates very intense pain.
Measured: seven days
Facial swelling
The swelling of the face in cm will be determined by measuring the distance from the corner of the mouth to the attachment of the earlobe following the curvature of the cheek and the distance from the outer canthus of the eye to the corner of the jaw. The arithmetic mean of the two measurements will be considered as reference. The difference between each postoperative measurement and baseline will indicate facial swelling for that day.
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Molar, FourthStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitro Valeria, Azienda Ospedaliera di Perugia
- Investigators
- Massimiliano Gilli, Dr, Principal investigator, Azienda Ospedaliera Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458478
- Sponsor's protocol ID
- CMF2
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim HS, Noh SU, Han YW, Kim KM, Kang H, Kim HO, Park YM. Therapeutic effects of topical application of ozone on acute cutaneous wound healing. J Korean Med Sci. 2009 Jun;24(3):368-74. doi: 10.3346/jkms.2009.24.3.368. Epub 2009 Jun 12.
PubMed 19543419Valacchi G, Fortino V, Bocci V. The dual action of ozone on the skin. Br J Dermatol. 2005 Dec;153(6):1096-100. doi: 10.1111/j.1365-2133.2005.06939.x.
PubMed 16307642Bocci V. Biological and clinical effects of ozone. Has ozone therapy a future in medicine? Br J Biomed Sci. 1999;56(4):270-9.
PubMed 10795372Martinez-Sanchez G, Al-Dalain SM, Menendez S, Re L, Giuliani A, Candelario-Jalil E, Alvarez H, Fernandez-Montequin JI, Leon OS. Therapeutic efficacy of ozone in patients with diabetic foot. Eur J Pharmacol. 2005 Oct 31;523(1-3):151-61. doi: 10.1016/j.ejphar.2005.08.020. Epub 2005 Sep 29.
PubMed 16198334Montevecchi M, Dorigo A, Cricca M, Checchi L. Comparison of the antibacterial activity of an ozonated oil with chlorhexidine digluconate and povidone-iodine. A disk diffusion test. New Microbiol. 2013 Jul;36(3):289-302. Epub 2013 Jun 30.
PubMed 23912871Osunde OD, Saheeb BD. Effect of age, sex and level of surgical difficulty on inflammatory complications after third molar surgery. J Maxillofac Oral Surg. 2015 Mar;14(1):7-12. doi: 10.1007/s12663-013-0586-4. Epub 2013 Oct 1.
PubMed 25729220Amin MM, Laskin DM. Prophylactic use of indomethacin for prevention of postsurgical complications after removal of impacted third molars. Oral Surg Oral Med Oral Pathol. 1983 May;55(5):448-51. doi: 10.1016/0030-4220(83)90227-x.
PubMed 6575332Marques RV, Branco-de-Almeida LS, Marques DM, Oliveira IC, Mendes SJ, Rodrigues VP, Lopes FF. Effect of the intra-alveolar administration of dexamethasone on swelling, trismus, and pain after impacted lower third molar extraction: a randomized, double-blind clinical trial. Med Oral Patol Oral Cir Bucal. 2022 Jan 1;27(1):e51-e58. doi: 10.4317/medoral.24894.
PubMed 34564685Cinquini C, Marchionni S, Derchi G, Miccoli M, Gabriele M, Barone A. Non-impacted tooth extractions and antibiotic treatment: A RCT study. Oral Dis. 2021 May;27(4):1042-1051. doi: 10.1111/odi.13607. Epub 2020 Sep 4.
PubMed 32790913Olmedo-Gaya MV, Manzano-Moreno FJ, Munoz-Lopez JL, Vallecillo-Capilla MF, Reyes-Botella C. Double-blind, randomized controlled clinical trial on analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction. Clin Oral Investig. 2018 Dec;22(9):2981-2988. doi: 10.1007/s00784-018-2386-1. Epub 2018 Feb 15.
PubMed 29450738Hadad H, Santos AFP, de Jesus LK, Poli PP, Mariano RC, Theodoro LH, Maiorana C, Souza FA. Photobiomodulation Therapy Improves Postoperative Pain and Edema in Third Molar Surgeries: A Randomized, Comparative, Double-Blind, and Prospective Clinical Trial. J Oral Maxillofac Surg. 2022 Jan;80(1):37.e1-37.e12. doi: 10.1016/j.joms.2021.08.267. Epub 2021 Sep 6.
PubMed 34656515
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Application of a Hyper-oxygenated Gel After Extraction of Impacted Lower Third Molars: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06458478
- Acronym / sponsor ID
- CMF2
- Conditions
- Molar, Fourth, Extracting Own Teeth, Edema Face, Pain, Trismus
- Keywords
- dysodontiasis, third molar, oral surgery, edema, trismus, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PerugiaUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 13 Jun 2024 (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 evaluate whether the topical application of Novox® Drop on surgical wounds after the extraction of lower third molars can have a clinical advantage.
The primary objective of the study is to evaluate the possible reduction of masseteric trismus (masticatory muscle spasm - primary outcome) and of post-operative pain and facial edema (swelling - secondary outcomes) after the extraction of impacted third molars compared to those who do not use it (placebo=glycerin-based gel).
Detailed description
Novox drop is a medical device (CE certified, class II b, non-invasive) based on oxygen-enriched olive oil (Excipients: Mint essential oil (2%), Stevia extract (1%)). Mechanism of action: facilitate the healing process by creating, thanks to the release of reactive oxygen species (ROS), a microenvironment favorable to the activation of the microcirculation and at the same time unfavorable to the proliferation of pathogens. Furthermore, it has a film-forming, protective, barrier and soothing action thanks to its oily nature.
The placebo consists of a viscous, colorless and transparent gel, based on glycerin (Conformity:FUI).
The company producing Novox Drop will package both gels in opaque disposable syringes, identical from each other and distinguishable only by the presence of an "A" or "B" code. During the phases of the study, only the company will be aware which of the two codes will be associated with the medical device and which will be associated with the placebo. The patients to be subjected to the study will be obtained from those arriving at the maxillofacial surgery clinics for the surgical extraction of complex lower third molars, starting from July 2024 until the necessary sample size of 72 participants is reached. Each of them, who will be assigned a sequential numerical code, will be placed randomly (randomized) in one of the two arms of the study itself, group A or group B, using the Excel Microsoft 2015 system.
Patients in group A, in addition to the standard antibiotic therapy (amoxicillin + clavulanic acid 1 g x 3 times a day x 7 days) and painkiller (paracetamol 1000 mg x 2 times a day x 7 days) will be prescribed the home use of syringe A. Patients in group B, in addition to the aforementioned traditional therapy, the syringe B. The gel prescribed in both groups must be applied to the post-extraction site 3 times a day for 7 days. Furthermore, after each application of the gels, the patient cannot consume drinks and solid foods for 30 minutes.
The duration of the study will be one week, and will be divided into three visits:
the first at time 0 as soon as the surgery is finished where all the hygiene recommendations will be made, the basic therapy drugs (antibiotic and anti-inflammatory) will be prescribed, and the gels will be prescribed in the A or B syringes; the second visit at time 1 three days after the operation and the third visit at time 2 after a week in which the patient's health status will be assessed, the study data will be collected, the blisters of the therapy performed will be collected and the hygiene advice will be reiterated .
For the administration method just described, the study will be a triple blind study, where neither the patient, nor the prescribing doctor nor the observer of the results of the surgical wounds will be aware of the type of gel used. Only the doctor responsible for cataloging and processing complete with the results you will be aware of which gel was contained in syringe A and which in syringe B.
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 |
|---|---|---|
| Hyper-oxygenated Gel | Active comparator | Other: Hyper-oxygenated gelPatients undergoing lower third molar extraction. Post-operatively, the antibiotic (amoxicillin + clavulanic acid) and the painkiller (paracetamol 1000mg x 2 times a day x 7 days) are prescribed. Furthermore, patients will have to use the Novox drop at the post-extraction site 3 times a day for 7 days (without taking liquids for 30 minutes after use). |
| Placebo | Placebo comparator | Other: glycerin based gelPatients undergoing lower third molar extraction. Post-operatively, the antibiotic (amoxicillin + clavulanic acid) and the painkiller (paracetamol 1000 mg x 2 times a day x 7 days) are prescribed. Furthermore, patients will have to use the Placebo, glycerin based gel, at the post-extraction site 3 times a day for 7 days (without taking liquids for 30 minutes after use). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- good systemic and local health conditions of the patient;
- age between 18 and 35 years;
- understanding of the Italian language,
- indications for the extraction of impacted bilateral lower third molars (38 and 48) according to the criteria reported in the classifications of Winter and that of Pell and Gregory;
- the root of the impacted third molars is completely formed.
Key exclusion criteria (11 listed)
- diabetes mellitus;
- systemic arterial hypertension;
- hyperthyroidism;
- osteoporosis;
- immunosuppressed;
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 |
|---|---|---|
| Hyper-oxygenated gelAlso: Novox dropNovox drop is a medical device (CE certified, class II b, non-invasive) based on oxygen-enriched olive oil (Excipients: Mint essential oil (2%), Stevia extract (1%)). Mechanism of action: facilitate the healing process by creating, thanks to the release of reactive oxygen species (ROS), a microenvironment favorable to the activation of the microcirculation and at the same time unfavorable to the proliferation of pathogens. Furthermore, it has a film-forming, protective, barrier and soothing action thanks to its oily nature. | Other | Hyper-oxygenated Gel |
| glycerin based gelThe placebo consists of a viscous, colorless and transparent gel, based on glycerin (Conformity:FUI). | Other | Placebo |
Primary outcome
Masseteric trismus.
Time frame: seven days
Masseteric trismus will be assessed by measuring the width of the mouth opening. Precisely, the distance in cm between the mesial corners of the incisal edges of the upper central incisors and the lower right incisors at maximum mouth opening, before surgery and on the seventh postoperative day, using a caliper. Measurements will be taken twice to determine the average score. The difference between the average of each postoperative measurement and the preoperative one will indicate the trismus for that day.
2 secondary outcomes
Post-operative pain
Time frame: seven days
Facial swelling
Time frame: seven days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 19543419Kim HS, Noh SU, Han YW, Kim KM, Kang H, Kim HO, Park YM. Therapeutic effects of topical application of ozone on acute cutaneous wound healing. J Korean Med Sci. 2009 Jun;24(3):368-74. doi: 10.3346/jkms.2009.24.3.368. Epub 2009 Jun 12.
- Background: PubMed 16307642Valacchi G, Fortino V, Bocci V. The dual action of ozone on the skin. Br J Dermatol. 2005 Dec;153(6):1096-100. doi: 10.1111/j.1365-2133.2005.06939.x.
- Background: PubMed 10795372Bocci V. Biological and clinical effects of ozone. Has ozone therapy a future in medicine? Br J Biomed Sci. 1999;56(4):270-9.
- Background: PubMed 16198334Martinez-Sanchez G, Al-Dalain SM, Menendez S, Re L, Giuliani A, Candelario-Jalil E, Alvarez H, Fernandez-Montequin JI, Leon OS. Therapeutic efficacy of ozone in patients with diabetic foot. Eur J Pharmacol. 2005 Oct 31;523(1-3):151-61. doi: 10.1016/j.ejphar.2005.08.020. Epub 2005 Sep 29.
- Background: PubMed 23912871Montevecchi M, Dorigo A, Cricca M, Checchi L. Comparison of the antibacterial activity of an ozonated oil with chlorhexidine digluconate and povidone-iodine. A disk diffusion test. New Microbiol. 2013 Jul;36(3):289-302. Epub 2013 Jun 30.
- Background: PubMed 25729220Osunde OD, Saheeb BD. Effect of age, sex and level of surgical difficulty on inflammatory complications after third molar surgery. J Maxillofac Oral Surg. 2015 Mar;14(1):7-12. doi: 10.1007/s12663-013-0586-4. Epub 2013 Oct 1.
- Background: PubMed 6575332Amin MM, Laskin DM. Prophylactic use of indomethacin for prevention of postsurgical complications after removal of impacted third molars. Oral Surg Oral Med Oral Pathol. 1983 May;55(5):448-51. doi: 10.1016/0030-4220(83)90227-x.
- Background: PubMed 34564685Marques RV, Branco-de-Almeida LS, Marques DM, Oliveira IC, Mendes SJ, Rodrigues VP, Lopes FF. Effect of the intra-alveolar administration of dexamethasone on swelling, trismus, and pain after impacted lower third molar extraction: a randomized, double-blind clinical trial. Med Oral Patol Oral Cir Bucal. 2022 Jan 1;27(1):e51-e58. doi: 10.4317/medoral.24894.
- Background: PubMed 32790913Cinquini C, Marchionni S, Derchi G, Miccoli M, Gabriele M, Barone A. Non-impacted tooth extractions and antibiotic treatment: A RCT study. Oral Dis. 2021 May;27(4):1042-1051. doi: 10.1111/odi.13607. Epub 2020 Sep 4.
- Background: PubMed 29450738Olmedo-Gaya MV, Manzano-Moreno FJ, Munoz-Lopez JL, Vallecillo-Capilla MF, Reyes-Botella C. Double-blind, randomized controlled clinical trial on analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction. Clin Oral Investig. 2018 Dec;22(9):2981-2988. doi: 10.1007/s00784-018-2386-1. Epub 2018 Feb 15.
- Background: PubMed 34656515Hadad H, Santos AFP, de Jesus LK, Poli PP, Mariano RC, Theodoro LH, Maiorana C, Souza FA. Photobiomodulation Therapy Improves Postoperative Pain and Edema in Third Molar Surgeries: A Randomized, Comparative, Double-Blind, and Prospective Clinical Trial. J Oral Maxillofac Surg. 2022 Jan;80(1):37.e1-37.e12. doi: 10.1016/j.joms.2021.08.267. Epub 2021 Sep 6.
- Individual participant dataSharing planned: No
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.
Massimiliano Gilli, Dr principal investigator
Azienda Ospedaliera Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyper-oxygenated gel and glycerin based gel in people with Molar, Fourth and Extracting Own Teeth, run by Azienda Ospedaliera di Perugia 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 5 inclusion and 11 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 13 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact valeria mitro, Dr (+393494509722, valeria.mitro@ospedale.perugia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masseteric trismus. (time frame: seven days). 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 NCT06458478, which also lists 11 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 13 Jun 2024.