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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started Dec 2020
Shorter than P25 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2021
CompletedSeptember 13, 2021
September 1, 2021
6 months
December 1, 2020
September 7, 2021
Conditions
Outcome Measures
Primary Outcomes (12)
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
Study Arms (2)
Bromelain and Escin
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Supportive care after oral surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of L'Aquilalead
- Dr. Leonardo Mancinicollaborator
- Tommaso Pizzolantecollaborator
Study Sites (1)
University of L'Aquila, Division of Periodontology
L’Aquila, AQ, 67100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Triple blind randomization and computer-based random allocation
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Enrico Marchetti
Study Record Dates
First Submitted
December 1, 2020
First Posted
December 8, 2020
Study Start
December 1, 2020
Primary Completion
May 15, 2021
Study Completion
May 27, 2021
Last Updated
September 13, 2021
Record last verified: 2021-09