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

Sponsor
University of L'Aquila (Other)
Overall Status
Completed
CT.gov ID
NCT04657874
Collaborator
Dr. Leonardo Mancini (Other), Tommaso Pizzolante (Other)
20
Enrollment
1
Location
2
Arms
5.8
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Bromelains and Escin Oral Tablet
  • Other: Placebo
 N/A

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

Study Type:
Interventional
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 :
Dec 1, 2020
Actual Primary Completion Date :
May 15, 2021
Actual Study Completion Date :
May 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bromelain and Escin

Other: Bromelains and Escin Oral Tablet
Supportive care after oral surgery
Other Names:
  • Noflogo®

    		•
    Placebo Comparator: Placebo

    Other: Placebo
    Oral tablet without the active principle

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. Trismus - Vertical Opening [Baseline]

      A calibre has been used to measure vertical opening.

    6. Trismus - Vertical Opening [Post-surgical - 30 min]

      A calibre has been used to measure vertical opening.

    7. Trismus - Vertical Opening [2 days]

      A calibre has been used to measure vertical opening.

    8. Trismus - Vertical Opening [7 days]

      A calibre has been used to measure vertical opening.

    9. 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"

    10. 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"

    11. 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"

    12. 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 Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of L'Aquila, Division of Periodontology L'aquila AQ Italy 67100

    Sponsors and Collaborators

    • University of L'Aquila
    • Dr. Leonardo Mancini
    • Tommaso Pizzolante

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Enrico Marchetti, Prof. Enrico Marchetti, University of L'Aquila
    ClinicalTrials.gov Identifier:
    NCT04657874
    Other Study ID Numbers:
    • RCT 002/2017
    First Posted:
    Dec 8, 2020
    Last Update Posted:
    Sep 13, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Pain, Postoperative

    Study Results

    No Results Posted as of Sep 13, 2021