Oral Soft Tissue ConditionsPhase 4NCT03335683
Phytotherapy Agent in Third Molar Surgery
A Phase 4 study testing Lenidase in people with Oral Soft Tissue Conditions, run by Gaetano Isola, DDS, PhD at 1 site in Italy.
Trial summary
The aim of the present study was to evaluate the effect of a phytotherapy agent on clinical and inflammatory parameters, for the postoperative therapy of the impacted third molar surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Soft Tissue Conditions
- What is being tested?
- Lenidase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2016to 30 Jun 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 30 years;
- good general health;
- the presence of two asymptomatic mandibular third molars with Class II position B impaction (Pell and Gregory, 1933), with similar root formation characteristics and position; absence of pericoronitis or signs of inflammation during the last 30 days. Ortopantomography (OPT) was used to determine tooth position.
Who cannot join
- any systemic condition which might affect the study;
- taking medications;
- use of hormonal contraceptives;
- medication by anti-inflammatory and immunosuppressive drugs;
- status of pregnancy or lactation;
- previous history of excessive drinking;
- allergy to local anesthetic;
- smoking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Phytotherapy Agent in Third Molar Surgery: a Split-mouth, Prospective, Randomized Study
The aim of the present study was to evaluate the effect of a phytotherapy agent on clinical and inflammatory parameters, for the postoperative therapy of the impacted third molar surgery. The null hypothesis to invalidate was that, after the last follow-up, there were no variations between the phytotherapy agent and the placebo.
Read the detailed description
The inclusion criteria were: (1) age between 18 and 32 years; (2) good general health; (3) the presence of two asymptomatic mandibular third molars with Class II position, type B impaction (Pell and Gregory, 1933), with similar root formation characteristics and position between the two sides; (4) absence of pericoronitis or signs of inflammation during the last 30 days. Orthopantomography (OPT) was used to determine tooth position. The exclusion criteria were (1) any systemic condition which might affect the study; (2) taking medications; (3) use of hormonal contraceptives; (4) medication by anti-inflammatory and immunosuppressive drugs; (5) status of pregnancy or lactation; (6) previous history of excessive drinking; (7) allergy to local anesthetic; (8) smoking.
The study was performed according to the CONSORT (Consolidated Standards Of Reporting Trials) guidelines. Patients who did not attend the second surgery or were unable to follow the study protocol were excluded, as were those whose surgical time exceeded 40 minutes.
Patients were scheduled for surgery in two separate clinical sessions (one side at a time), with a 1-month interval. Subjects were allocated to one of two groups according to the medication received 1 h and 12 h after surgery: group 1, Lenidase® (Enfarma SRL, Misterbianco, Italy); group 2, placebo (Sugar pill, Sucratol - Placebo Capsules). All patients in the study routinely received a prophylactic preoperative dose of oral antibiotic (1 g amoxicillin/clavulanic acid 1 hour before surgery) (Augmentin; GlaxoSmithKline, Verona, Italy).
- Conditions
- Oral Soft Tissue Conditions
- Being tested
- Lenidase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenidaseDrug
Also called Placebo
drug per os twice day for 7 days, or for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Phytoterapy agent | Experimental | Subjects were allocated to receive 1 h and 12 h after surgery: group 1, Lenidase® (Enfarma SRL, Misterbianco, Italy) Receives: Drug: Lenidase |
| Placebo | Placebo comparator | Subjects were allocated to received 1 h and 12 h after surgery: placebo (Sugar pill, Sucratol - Placebo Capsules). Receives: Drug: Lenidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
visual analogue scale (VAS), a score of 1 to 10. A score of 0 indicated no pain and 10, the worst pain.
Measured: 10 days
Secondary outcomes (1)
Swelling
Facial measure: swelling on the facial side receiving surgery. Measurement tragus to the nasal border (Tr-Al).
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start7 Jan 2016
- Primary completion20 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Soft Tissue ConditionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Split mouth design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaetano Isola, DDS, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gaetano Isola, DDS, PhD, University of Messina
- Investigators
- Giovanni Matarese, DDS, Study director, Univeristy of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335683
- Sponsor's protocol ID
- 09/17
- Status last verified
- Nov 2017
- First submitted
- 29 Oct 2017
- Last updated
- 8 Nov 2017
- 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 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Phytotherapy Agent in Third Molar Surgery: a Split-mouth, Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03335683
- Acronym / sponsor ID
- 09/17
- Conditions
- Oral Soft Tissue Conditions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Gaetano Isola, DDS, PhDUniversity, hospital or other
- Study start
- 7 Jan 2016 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 8 Nov 2017 (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.
The aim of the present study was to evaluate the effect of a phytotherapy agent on clinical and inflammatory parameters, for the postoperative therapy of the impacted third molar surgery. The null hypothesis to invalidate was that, after the last follow-up, there were no variations between the phytotherapy agent and the placebo.
Detailed description
The inclusion criteria were: (1) age between 18 and 32 years; (2) good general health; (3) the presence of two asymptomatic mandibular third molars with Class II position, type B impaction (Pell and Gregory, 1933), with similar root formation characteristics and position between the two sides; (4) absence of pericoronitis or signs of inflammation during the last 30 days. Orthopantomography (OPT) was used to determine tooth position. The exclusion criteria were (1) any systemic condition which might affect the study; (2) taking medications; (3) use of hormonal contraceptives; (4) medication by anti-inflammatory and immunosuppressive drugs; (5) status of pregnancy or lactation; (6) previous history of excessive drinking; (7) allergy to local anesthetic; (8) smoking.
The study was performed according to the CONSORT (Consolidated Standards Of Reporting Trials) guidelines. Patients who did not attend the second surgery or were unable to follow the study protocol were excluded, as were those whose surgical time exceeded 40 minutes.
Patients were scheduled for surgery in two separate clinical sessions (one side at a time), with a 1-month interval. Subjects were allocated to one of two groups according to the medication received 1 h and 12 h after surgery: group 1, Lenidase® (Enfarma SRL, Misterbianco, Italy); group 2, placebo (Sugar pill, Sucratol - Placebo Capsules). All patients in the study routinely received a prophylactic preoperative dose of oral antibiotic (1 g amoxicillin/clavulanic acid 1 hour before surgery) (Augmentin; GlaxoSmithKline, Verona, Italy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth design
| Arm | Type | Receives |
|---|---|---|
| Phytoterapy agent | Experimental | Drug: LenidaseSubjects were allocated to receive 1 h and 12 h after surgery: group 1, Lenidase® (Enfarma SRL, Misterbianco, Italy) |
| Placebo | Placebo comparator | Drug: LenidaseSubjects were allocated to received 1 h and 12 h after surgery: placebo (Sugar pill, Sucratol - Placebo Capsules). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 30 years;
- good general health;
- the presence of two asymptomatic mandibular third molars with Class II position B impaction (Pell and Gregory, 1933), with similar root formation characteristics and position; absence of pericoronitis or signs of inflammation during the last 30 days. Ortopantomography (OPT) was used to determine tooth position.
Key exclusion criteria (8 listed)
- any systemic condition which might affect the study;
- taking medications;
- use of hormonal contraceptives;
- medication by anti-inflammatory and immunosuppressive drugs;
- status of pregnancy or lactation;
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 |
|---|---|---|
| LenidaseAlso: Placebodrug per os twice day for 7 days, or for 10 days | Drug | Phytoterapy agent, Placebo |
Primary outcome
Pain
Time frame: 10 days
visual analogue scale (VAS), a score of 1 to 10. A score of 0 indicated no pain and 10, the worst pain.
1 secondary outcome
Swelling
Time frame: 10 days
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 8 Nov 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Oral Soft Tissue Conditions
Not yet recruiting
Buccal Periosteal Inversion Flap vs Buccal Advancement Flap for Acute Oro-Antral Communication Closure
Acute Oroantral Communication
Not yet recruitingPhase 3
Naproxen Versus Placebo as Adjunct Treatment of Cellulitis
Cellulitis, Skin Disease, Infectious
Active, not recruitingPhase 1/2
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
Solid Tumors, CNS Tumors
Active, not recruitingPhase 1
Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial
Advanced Breast Carcinoma, Advanced Colon Carcinoma
RecruitingObservational study
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
Cancer Risk, Cancer Predisposition Syndrome
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.
Giovanni Matarese, DDS study director
Univeristy of Messina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lenidase in people with Oral Soft Tissue Conditions, run by Gaetano Isola, DDS, PhD 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 8 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 8 Nov 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain (time frame: 10 days). 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 8 Nov 2017.