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

University of L'Aquila

Status

Completed

Conditions

Edema

Postoperative Pain

Swelling Lips & Face

Treatments

Other: Placebo

Other: Bromelains and Escin Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT04657874

RCT 002/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 80 years old

Volunteers

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