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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain, Edema, Swelling Lips & Face

Intervention / Treatment
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* Other: Bromelains and Escin Oral Tablet
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bromelain and Escin<br> | Other: Bromelains and Escin Oral Tablet<br>* Supportive care after oral surgery<br>* Other names: Noflogo®;|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Oral tablet without the active principle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |