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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
20
Supportive care after oral surgery
Oral tablet without the active principle
University of L'Aquila, Division of Periodontology
L’Aquila, AQ, Italy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7 days
Trismus - Vertical Opening
A calibre has been used to measure vertical opening.
Time frame: Baseline
Trismus - Vertical Opening
A calibre has been used to measure vertical opening.
Time frame: Post-surgical - 30 min
Trismus - Vertical Opening
A calibre has been used to measure vertical opening.
Time frame: 2 days
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Trismus - Vertical Opening
A calibre has been used to measure vertical opening.
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 7 days