Edema, Postoperative Pain, Swelling Lips & Face
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERBromelains and Escin Oral Tablet
Supportive care after oral surgery
OTHERPlacebo
Oral tablet without the active principle
Sponsors
Dr. Leonardo Mancini
Tommaso Pizzolante
University of L'Aquila
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Triple blind randomization and computer-based random allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* No signs of gingival inflammation; * FMBS and FMPS ≤ 20% after non-surgical causal therapy (Only for patients undergoing periodontal surgery) * Smokers have to indicate how many cigarettes they smoke and how long have they been smoking
Exclusion criteria
* Gingival inflammation * Positive anamensis for relevant systemic pathologies (renal, cardiovascular, hepatic, infectious, neoplastic and diabetological) * Treatment with anti-inflammatory and/or antibiotics in the two weeks preceding the start of the trial * History of allergy to one or more components of the medication to be tested * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Edema - Cheek Volume | Baseline | 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. |
| Trismus - Vertical Opening | Baseline | A calibre has been used to measure vertical opening. |
| Pain - (VAS) | Baseline | 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 |
Countries
Italy
Outcome results
None listed