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Completed

NCT Number: NCT04657874

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

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.

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Key information

Conditions

Postoperative Pain Disease Attributes Edema Facies Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Swelling Lips & Face

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of L'Aquila, Division of Periodontology

L’Aquila, AQ, 67100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bromelains and Escin Oral Tablet

Other

Supportive care after oral surgery

Other names: Noflogo®

Placebo

Other

Oral tablet without the active principle

Primary outcomes

  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"

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Collaborators

  • Dr. Leonardo Mancini
  • Tommaso Pizzolante

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2020
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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