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

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

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.

Study Overview

• Status: Completed
• Conditions: Edema; Postoperative Pain; Swelling Lips & Face
• Intervention / Treatment: Other: Bromelains and Escin Oral Tablet; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • AQ
    • L'aquila, AQ, Italy, 67100
      • University of L'Aquila, division of periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo; Oral tablet without the active principle
ACTIVE_COMPARATOR: Bromelain and Escin	Other: Bromelains and Escin Oral Tablet; Supportive care after oral surgery; Other Names: Noflogo®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	7 days
Trismus - Vertical Opening	A calibre has been used to measure vertical opening.	Baseline
Trismus - Vertical Opening	A calibre has been used to measure vertical opening.	Post-surgical - 30 min
Trismus - Vertical Opening	A calibre has been used to measure vertical opening.	2 days
Trismus - Vertical Opening	A calibre has been used to measure vertical opening.	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"	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"	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"	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"	7 days

Collaborators and Investigators

• Sponsor: University of L'Aquila
• Collaborators: Dr. Leonardo Mancini; Tommaso Pizzolante

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ACTUAL): May 15, 2021
• Study Completion (ACTUAL): May 27, 2021

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (ACTUAL): December 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: RCT 002/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No