Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dr. Leonardo Mancini | UNKNOWN |
| Tommaso Pizzolante | UNKNOWN |
Not provided
Not provided
Not provided
A randomized clinical trial will be performed in parallel, placebo controlled, triple-blind to evaluate the effectiveness of the association Bromelina and Horse-chestnut (titrated in escin) (Noflogo®, Mavenpharma s.r.l., Rome, Italy) in the management of post trauma-surgery following surgery periodontal and implant surgery.
At least 50 volunteers between the ages of 18 and 50, will be enlisted, with the need to perform one of the interventions described above and that fall within the criteria of inclusion.
The study will be carried out in accordance with the Helsinki Declaration on In Vivo Studies and will be initiated with the approval of the Internal Review Board of the University of L'Aquila.
The protocol follows the guidelines of the CONSORT Statement for parallel studies and will be recorded on the data base clinicaltrials.gov.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bromelain and Escin | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromelains and Escin Oral Tablet | Other | Supportive care after oral surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Edema - Cheek Volume | The distance between the angle of the mouth and the lobe of the ear and the distance between the outer side of the eye and the angle of the jaw, following the bulge of the cheek. In addition, where possible, a facial scanner has been used. | Baseline |
| Edema - Cheek Volume | The distance between the angle of the mouth and the lobe of the ear and the distance between the outer side of the eye and the angle of the jaw, following the bulge of the cheek. In addition, where possible, a facial scanner has been used. | Post-surgical - 30 min |
| Edema - Cheek Volume | The distance between the angle of the mouth and the lobe of the ear and the distance between the outer side of the eye and the angle of the jaw, following the bulge of the cheek. In addition, where possible, a facial scanner has been used. | 2 days |
| Edema - Cheek Volume | The distance between the angle of the mouth and the lobe of the ear and the distance between the outer side of the eye and the angle of the jaw, following the bulge of the cheek. In addition, where possible, a facial scanner has been used. | 7 days |
| Trismus - Vertical Opening | A calibre has been used to measure vertical opening. | Baseline |
| Trismus - Vertical Opening | A calibre has been used to measure vertical opening. | Post-surgical - 30 min |
| Trismus - Vertical Opening |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of L'Aquila, Division of Periodontology | L’Aquila | AQ | 67100 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D004487 | Edema |
| D019066 | Facies |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D001963 | Bromelains |
| D004928 | Escin |
| ID | Term |
|---|---|
| D003546 | Cysteine Endopeptidases |
| D057056 | Cysteine Proteases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Triple blind randomization and computer-based random allocation
| Placebo | Other | Oral tablet without the active principle |
|
A calibre has been used to measure vertical opening. |
| 2 days |
| Trismus - Vertical Opening | A calibre has been used to measure vertical opening. | 7 days |
| Pain - (VAS) | The patient fills in the visual analog scale. This scale has values from 0 to 10 where 0 indicates "no pain" and 10 indicates "worst pain imaginable" | Baseline |
| Pain - (VAS) | The patient fills in the visual analog scale. This scale has values from 0 to 10 where 0 indicates "no pain" and 10 indicates "worst pain imaginable" | Post-surgical - 30 min |
| Pain - (VAS) | The patient fills in the visual analog scale. This scale has values from 0 to 10 where 0 indicates "no pain" and 10 indicates "worst pain imaginable" | 2 days |
| Pain - (VAS) | The patient fills in the visual analog scale. This scale has values from 0 to 10 where 0 indicates "no pain" and 10 indicates "worst pain imaginable" | 7 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020969 | Disease Attributes |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010450 | Endopeptidases |
| D053978 | Pentacyclic Triterpenes |
| D014315 | Triterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D012503 | Saponins |
| D006027 | Glycosides |
| D002241 | Carbohydrates |