Trial Outcomes & Findings for OZONE_EXO: Comparative Analysis of Protocols for Dental Exactions in Patients at Risk of MRONJ: Case-control Study (NCT NCT06072404)
NCT ID: NCT06072404
Last Updated: 2025-01-09
Results Overview
The inflammatory phase is evaluated 3-5 days after tissue injury on the basis of eight parameters, measured on a 9-point scale (0-8): bleeding (spontaneously or on palpation), granulation tissue, hematoma, tissue color, incision margins, suppuration, edema, and pain. A score of 5-8 indicates a successful inflammatory phase
COMPLETED
PHASE1/PHASE2
117 participants
3-5 days after the intervention
2025-01-09
Participant Flow
Potential participants were identified among patients attending the "Oral Medicine with Dentistry for Fragile Patients Unit" at the Paolo Giaccone Policlinico University Hospital of Palermo from February 2018 to March 2020. Patients were approached with written and verbal information about the study.
The study recruited 117 patients (27 male and 90 female) and were randomized to treatment.
Participant milestones
| Measure |
Group A (OZONE_EXO)
intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site in patients at risk of medication-induced osteonecrosis of the jaw (ONJ).
OxigenOzone\_Insufflation: intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx 1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site for at least 1 minute, hemostasis, and suture.
|
Group B (NO_OZONE_EXO)
Tooth extraction in patients at risk of medication-induced osteonecrosis of the jaw (ONJ) without the use of ozone application.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
79
|
|
Overall Study
COMPLETED
|
38
|
79
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OZONE_EXO: Comparative Analysis of Protocols for Dental Exactions in Patients at Risk of MRONJ: Case-control Study
Baseline characteristics by cohort
| Measure |
Group A (OZONE_EXO)
n=38 Participants
intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site in patients at risk of medication-induced osteonecrosis of the jaw (ONJ).
OxigenOzone\_Insufflation: intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx 1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site for at least 1 minute, hemostasis, and suture.
|
Group B (NO_OZONE_EXO)
n=79 Participants
Tooth extraction in patients at risk of medication-induced osteonecrosis of the jaw (ONJ) without the use of ozone application.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
38 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3-5 days after the interventionThe inflammatory phase is evaluated 3-5 days after tissue injury on the basis of eight parameters, measured on a 9-point scale (0-8): bleeding (spontaneously or on palpation), granulation tissue, hematoma, tissue color, incision margins, suppuration, edema, and pain. A score of 5-8 indicates a successful inflammatory phase
Outcome measures
| Measure |
Group A (OZONE_EXO)
n=38 Participants
intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site in patients at risk of medication-induced osteonecrosis of the jaw (ONJ).
OxigenOzone\_Insufflation: intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx 1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site for at least 1 minute, hemostasis, and suture.
|
Group B (NO_OZONE_EXO)
n=79 Participants
Tooth extraction in patients at risk of medication-induced osteonecrosis of the jaw (ONJ) without the use of ozone application.
|
|---|---|---|
|
Healing Evaluation Using Inflammatory-Proliferative-Remodelling Scale (IPR Scale): Inflammatory Phase
|
2 score on a scale
Standard Deviation 0.87
|
2.49 score on a scale
Standard Deviation 0.875
|
PRIMARY outcome
Timeframe: 14 days after the interventionThe proliferative phase is evaluated 14 days after tissue injury on the basis of five parameters, measured on a 6-point scale (0-5): re-epithelialization, tissue color, scar, suppuration, and pain. A score of 3-5 score indicates successful healing.
Outcome measures
| Measure |
Group A (OZONE_EXO)
n=38 Participants
intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site in patients at risk of medication-induced osteonecrosis of the jaw (ONJ).
OxigenOzone\_Insufflation: intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx 1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site for at least 1 minute, hemostasis, and suture.
|
Group B (NO_OZONE_EXO)
n=79 Participants
Tooth extraction in patients at risk of medication-induced osteonecrosis of the jaw (ONJ) without the use of ozone application.
|
|---|---|---|
|
Healing Evaluation Using Inflammatory-Proliferative-Remodelling Scale (IPR Scale): Proliferative Phase:
|
4.24 score on a scale
Standard Deviation 1.51
|
3.7 score on a scale
Standard Deviation 1.02
|
PRIMARY outcome
Timeframe: 6 weeks after the interventionThe remodeling phase is evaluated 6 weeks after tissue injury on the basis of three parameters, measured on a 4-point scale (0-3): scar, tissue color, and pain. A score of 2-3 indicates successful healing
Outcome measures
| Measure |
Group A (OZONE_EXO)
n=38 Participants
intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site in patients at risk of medication-induced osteonecrosis of the jaw (ONJ).
OxigenOzone\_Insufflation: intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx 1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site for at least 1 minute, hemostasis, and suture.
|
Group B (NO_OZONE_EXO)
n=79 Participants
Tooth extraction in patients at risk of medication-induced osteonecrosis of the jaw (ONJ) without the use of ozone application.
|
|---|---|---|
|
Healing Evaluation Using Inflammatory-Proliferative-Remodelling Scale (IPR Scale): Remodelling Phase
|
3 score on a scale
Standard Deviation 0
|
2.96 score on a scale
Standard Deviation 0.192
|
SECONDARY outcome
Timeframe: 6 weekThe total score of the IPR scale ranges from 0 to 16:0-4 indicates poor healing; 5-10, acceptable healing; and 11-16, excellent healing The inflammatory phase carries the greatest weight in the final score because its impairment can jeopardize the entire series of biologic events leading to early wound healing.
Outcome measures
| Measure |
Group A (OZONE_EXO)
n=38 Participants
intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site in patients at risk of medication-induced osteonecrosis of the jaw (ONJ).
OxigenOzone\_Insufflation: intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx 1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site for at least 1 minute, hemostasis, and suture.
|
Group B (NO_OZONE_EXO)
n=79 Participants
Tooth extraction in patients at risk of medication-induced osteonecrosis of the jaw (ONJ) without the use of ozone application.
|
|---|---|---|
|
Healing Evaluation Using IPR Scale: Total Process
|
9.37 score on a scale
Standard Deviation 1.79
|
9.15 score on a scale
Standard Deviation 1.38
|
Adverse Events
Group A (OZONE_EXO)
Group B (NO_OZONE_EXO)
Serious adverse events
| Measure |
Group A (OZONE_EXO)
n=38 participants at risk
intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site in patients at risk of medication-induced osteonecrosis of the jaw (ONJ).
OxigenOzone\_Insufflation: intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx 1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site for at least 1 minute, hemostasis, and suture.
|
Group B (NO_OZONE_EXO)
n=79 participants at risk
Tooth extraction in patients at risk of medication-induced osteonecrosis of the jaw (ONJ) without the use of ozone application.
|
|---|---|---|
|
Infections and infestations
Osteonecrosis of the jaw
|
0.00%
0/38 • 6 weeks
|
0.00%
0/79 • 6 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place