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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04657874
Recruitment Status : Completed
First Posted : December 8, 2020
Last Update Posted : September 13, 2021
Sponsor:
Collaborators:
Dr. Leonardo Mancini
Tommaso Pizzolante
Information provided by (Responsible Party):
Enrico Marchetti, University of L'Aquila

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Edema Swelling Lips & Face Other: Bromelains and Escin Oral Tablet Other: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Triple blind randomization and computer-based random allocation
Primary Purpose: Supportive Care
Official Title: Association Between Bromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery: Randomized Clinical Trial, Placebo-controlled, Double-blind
Actual Study Start Date : December 1, 2020
Actual Primary Completion Date : May 15, 2021
Actual Study Completion Date : May 27, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Escin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bromelain and Escin Other: Bromelains and Escin Oral Tablet
Supportive care after oral surgery
Other Name: Noflogo®
Placebo Comparator: Placebo Other: Placebo
Oral tablet without the active principle


Outcome Measures
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Primary Outcome Measures :
  1. Edema - Cheek Volume [ Time Frame: 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.

  2. Edema - Cheek Volume [ Time Frame: 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.

  3. Edema - Cheek Volume [ Time Frame: 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.

  4. Edema - Cheek Volume [ Time Frame: 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.

  5. Trismus - Vertical Opening [ Time Frame: Baseline ]
    A calibre has been used to measure vertical opening.

  6. Trismus - Vertical Opening [ Time Frame: Post-surgical - 30 min ]
    A calibre has been used to measure vertical opening.

  7. Trismus - Vertical Opening [ Time Frame: 2 days ]
    A calibre has been used to measure vertical opening.

  8. Trismus - Vertical Opening [ Time Frame: 7 days ]
    A calibre has been used to measure vertical opening.

  9. Pain - (VAS) [ Time Frame: 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"

  10. Pain - (VAS) [ Time Frame: 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"

  11. Pain - (VAS) [ Time Frame: 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"

  12. Pain - (VAS) [ Time Frame: 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 Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657874


Locations
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Italy
University of L'Aquila, Division of Periodontology
L'aquila, AQ, Italy, 67100
Sponsors and Collaborators
University of L'Aquila
Dr. Leonardo Mancini
Tommaso Pizzolante
More Information
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Responsible Party: Enrico Marchetti, Prof. Enrico Marchetti, University of L'Aquila
ClinicalTrials.gov Identifier: NCT04657874    
Other Study ID Numbers: RCT 002/2017
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations