Back to resultsBromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery
Primary Purpose
Postoperative Pain, Edema, Swelling Lips & Face
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Bromelains and Escin Oral Tablet
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain
Eligibility 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
Sites / Locations
- University of L'Aquila, Division of Periodontology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Bromelain and Escin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Trismus - Vertical Opening
A calibre has been used to measure vertical opening.
Trismus - Vertical Opening
A calibre has been used to measure vertical opening.
Trismus - Vertical Opening
A calibre has been used to measure vertical opening.
Trismus - Vertical Opening
A calibre has been used to measure vertical opening.
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"
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"
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"
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"
Secondary Outcome Measures
Full Information
NCT ID
NCT04657874
First Posted
December 1, 2020
Last Updated
September 7, 2021
Sponsor
University of L'Aquila
Collaborators
Dr. Leonardo Mancini, Tommaso Pizzolante
1. Study Identification
Unique Protocol Identification Number
NCT04657874
Brief Title
Bromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of L'Aquila
Collaborators
Dr. Leonardo Mancini, Tommaso Pizzolante
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Edema, Swelling Lips & Face
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Triple blind randomization and computer-based random allocation
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bromelain and Escin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Bromelains and Escin Oral Tablet
Other Intervention Name(s)
Noflogo®
Intervention Description
Supportive care after oral surgery
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral tablet without the active principle
Primary Outcome Measure Information:
Title
Edema - Cheek Volume
Description
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.
Time Frame
Baseline
Title
Edema - Cheek Volume
Description
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.
Time Frame
Post-surgical - 30 min
Title
Edema - Cheek Volume
Description
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.
Time Frame
2 days
Title
Edema - Cheek Volume
Description
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.
Time Frame
7 days
Title
Trismus - Vertical Opening
Description
A calibre has been used to measure vertical opening.
Time Frame
Baseline
Title
Trismus - Vertical Opening
Description
A calibre has been used to measure vertical opening.
Time Frame
Post-surgical - 30 min
Title
Trismus - Vertical Opening
Description
A calibre has been used to measure vertical opening.
Time Frame
2 days
Title
Trismus - Vertical Opening
Description
A calibre has been used to measure vertical opening.
Time Frame
7 days
Title
Pain - (VAS)
Description
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"
Time Frame
Baseline
Title
Pain - (VAS)
Description
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"
Time Frame
Post-surgical - 30 min
Title
Pain - (VAS)
Description
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"
Time Frame
2 days
Title
Pain - (VAS)
Description
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"
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of L'Aquila, Division of Periodontology
City
L'aquila
State/Province
AQ
ZIP/Postal Code
67100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Bromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery
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