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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657874
• Other study ID #: RCT 002/2017
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: May 27, 2021

Study information

• Verified date: September 2021
• Source: University of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 27, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Pain, Postoperative
• Postoperative Pain
• Swelling Lips & Face

Intervention

Other:
• Bromelains and Escin Oral Tablet
Supportive care after oral surgery
• Placebo
Oral tablet without the active principle

Locations

Country	Name	City	State
Italy	University of L'Aquila, Division of Periodontology	L'aquila	AQ

Sponsors (3)

Lead Sponsor	Collaborator
University of L'Aquila	Dr. Leonardo Mancini, Tommaso Pizzolante

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Trismus - Vertical Opening	A calibre has been used to measure vertical opening.	Baseline
Primary	Trismus - Vertical Opening	A calibre has been used to measure vertical opening.	Post-surgical - 30 min
Primary	Trismus - Vertical Opening	A calibre has been used to measure vertical opening.	2 days
Primary	Trismus - Vertical Opening	A calibre has been used to measure vertical opening.	7 days
Primary	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
Primary	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
Primary	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
Primary	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