Postoperative PainNCT04657874
Bromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery
A study testing Bromelains and Escin Oral Tablet in people with Postoperative Pain and Edema, run by University of L'Aquila at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Edema, Swelling Lips & Face
- What is being tested?
- Bromelains and Escin Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 27 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of L'Aquila, Division of Periodontology
L’Aquila, AQ, 67100
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Pain, Edema, Swelling Lips & Face
- Being tested
- Bromelains and Escin Oral Tablet, Placebo
- Medical subject headings
- Pain, Postoperative, Edema, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromelains and Escin Oral TabletOther
Also called Noflogo®
Supportive care after oral surgery
PlaceboOther
Oral tablet without the active principle
| Study group | Role | What they receive |
|---|---|---|
| Bromelain and Escin | Active comparator | Not described Receives: Other: Bromelains and Escin Oral Tablet |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days
Trismus - Vertical Opening
A calibre has been used to measure vertical opening.
Measured: Baseline
Trismus - Vertical Opening
A calibre has been used to measure vertical opening.
Measured: Post-surgical - 30 min
Trismus - Vertical Opening
A calibre has been used to measure vertical opening.
Measured: 2 days
Trismus - Vertical Opening
A calibre has been used to measure vertical opening.
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Dec 2020
- Primary completion15 May 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Leonardo Mancini, Tommaso Pizzolante
- Responsible party
- Principal investigator, Enrico Marchetti, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657874
- Sponsor's protocol ID
- RCT 002/2017
- Status last verified
- Sep 2021
- First submitted
- 1 Dec 2020
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04657874
- Acronym / sponsor ID
- RCT 002/2017
- Conditions
- Postoperative Pain, Edema, Swelling Lips & Face
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Collaborators
- Dr. Leonardo Mancini, Tommaso Pizzolante
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bromelain and Escin | Active comparator | Other: Bromelains and Escin Oral Tablet |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bromelains and Escin Oral TabletAlso: Noflogo®Supportive care after oral surgery | Other | Bromelain and Escin |
| PlaceboOral tablet without the active principle | Other | Placebo |
Primary outcome
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.
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.
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.
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.
Trismus - Vertical Opening
Time frame: Baseline
A calibre has been used to measure vertical opening.
Trismus - Vertical Opening
Time frame: Post-surgical - 30 min
A calibre has been used to measure vertical opening.
Trismus - Vertical Opening
Time frame: 2 days
A calibre has been used to measure vertical opening.
Trismus - Vertical Opening
Time frame: 7 days
A calibre has been used to measure vertical opening.
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"
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"
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"
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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bromelains and Escin Oral Tablet in people with Postoperative Pain and Edema, run by University of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema - Cheek Volume (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.