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

Not Applicable

Completed

• Conditions: Postoperative Pain; Swelling Lips & Face; Edema
• Interventions: Other: Bromelains and Escin Oral Tablet; Other: Placebo

• Registration Number: NCT04657874
• Lead Sponsor: University of L'Aquila

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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-08
• Primary Completion: 2021-05-15
• Study Completion: 2021-05-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bromelain and Escin	Bromelains and Escin Oral Tablet	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Trismus - Vertical Opening	7 days	A calibre has been used to measure vertical opening.
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.
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"

Trial Locations

Locations (1)

University of L'Aquila, Division of Periodontology; 🇮🇹 L'aquila, AQ, Italy