Bromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery

NCT04657874 — Not applicable, Completed, 20 participants, University of L'Aquila

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Association Between Bromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery: Randomized Clinical Trial, Placebo-controlled, Double-blind

Registry	NCT04657874
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, supportive care
Enrollment	20 (Actual)
Sponsor	University of L'Aquila (Other); collaborators: Dr. Leonardo Mancini, Tommaso Pizzolante
Conditions	Postoperative Pain, Edema, Swelling Lips & Face
Interventions	Bromelains and Escin Oral Tablet, Placebo (Other)
Dates	start 2020-12-01, primary completion 2021-05-15, completion 2021-05-27, first posted 2020-12-08, last updated 2021-09-13
Locations	1 site in Italy

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Bromelain and Escin	Active comparator	Other: Bromelains and Escin Oral Tablet
Placebo	Placebo comparator	Other: Placebo

Bromelains and Escin Oral Tablet (Other), also known as Noflogo®: Supportive care after oral surgery
Placebo (Other): Oral tablet without the active principle

+Outcome measures

Primary outcomes

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.
Edema - Cheek Volume [Post-surgical - 30 min]: 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.
Edema - Cheek Volume [2 days]: 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.
Edema - Cheek Volume [7 days]: 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.
Trismus - Vertical Opening [Post-surgical - 30 min]: A calibre has been used to measure vertical opening.
Trismus - Vertical Opening [2 days]: A calibre has been used to measure vertical opening.
Trismus - Vertical Opening [7 days]: 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"
Pain - (VAS) [Post-surgical - 30 min]: 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"
Pain - (VAS) [2 days]: 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"
Pain - (VAS) [7 days]: 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"

+Eligibility

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
University of L'Aquila, Division of Periodontology	L’Aquila, AQ	Italy