louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03725995: Using Intranasal Midazolam (INM) and Lidocaine for Uncooperative Children
Official title: The Effectiveness of Topical Lidocaine in Relieving Pain Related To Intranasal Midazolam Sedation: A Randomized, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Burning Nose
Keywords: midazolam
Lidocaine
Intranasal
Burning
Children
Lead sponsor: Tishreen University
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 63
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: blinded, randomized placebo-controlled trial, comparing three groups.
Primary purpose: TREATMENT

Brief summary: Aims: The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.

Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11.

Detailed description: Background and Aims: The use of intranasal midazolam (INM) has been commonly associated with a burning sensation of the nasal mucosa. However, despite its significance, this subject has received little adequate research focus. The objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to INM administration.

Design: This was a blinded, randomized placebo-controlled trial. Sixty-three uncooperative children, aged 4 - 11, were randomly assigned to one of three groups to receive the drug nasally via a pre-calibrated spray as per the following assignments:

A: received 0.5 mg/kg midazolam, B: received lidocaine 2% prior to 0.5 mg/kg midazolam.

C: received saline 9% (placebo), 0.5mg/kg. Children were asked to record the degree of pain using Wong-Baker-Faces- (WBFS) Scale.

Eligibility criteria: Inclusion Criteria:

* uncooperative children scored 1 or 2 on Frankle Scale.
* had no medical history of neurological or cognitive alterations.
* No facial deformities.
* ASA Classification I.
* requiring dental treatment under local anesthesia.

Exclusion Criteria:

* known allergy to midazolam or any other benzodiazepines.
* upper respiratory tract infection with nasal discharge.

Primary outcomes:
measure: Changes in Pain Scores on the Wong Baker Faces Scale for pain assessment when administering midazolam alone, saline or midazolam premidicated with lidocaine .
timeFrame: one to five minutes following the administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen University
Study officials:
affiliation: Tishreen University
name: Nabih Raslan, Dr.
role: STUDY_CHAIR
affiliation: Tishreen University
name: Walaa Khalil, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith D, Cheek H, Denson B, Pruitt CM. Lidocaine Pretreatment Reduces the Discomfort of Intranasal Midazolam Administration: A Randomized, Double-blind, Placebo-controlled Trial. Acad Emerg Med. 2017 Feb;24(2):161-167. doi: 10.1111/acem.13115. Epub 2017 Jan 30.
Clinical trial NCT04000295: Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer
Official title: AMELIE: A Phase 3 Randomized, Open-label, Multicenter Trial of Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant or Refractory Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ovarian Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-27
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with weekly paclitaxel (80 mg/m2, d1, d8, d15, q3w).


Eligibility criteria: Inclusion Criteria:

1. 18 Years and older
2. Epithelial ovarian, fallopian tube or primary peritoneal cancer
3. Platinum refractory and resistant disease (disease progression during platinum therapy or within 6 months of platinum therapy)
4. EOCG performance status of 0-1

Exclusion Criteria:

1. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
2. Known hypersensitivity to any of the study drugs or excipients.
3. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
4. Congenital or acquired immune deficiency (e.g. HIV infected)

Primary outcomes:
measure: Progression free survival(PFS) by independent review committee(IRC)
timeFrame: up to approximately 2 years
Secondary outcomes:
measure: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: up to approximately 2 years
measure: PFS by investigator
timeFrame: up to approximately 2 years
measure: Objective Response Rate (ORR)
timeFrame: up to approximately 2 years
measure: Overall Survival (OS)
timeFrame: up to approximately 3 years
measure: EQ-5D-5L questionnaire
timeFrame: up to approximately 2 years
measure: FOSI-8 questionnaire
timeFrame: up to approximately 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05330195: Bicycle Ergometer Training in Duchenne Muscular Dystrophy
Official title: The Effects of Bicycle Training on Gait and Balance in Children With Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Keywords: Duchenne muscular dystrophy
Bicycle training
Gait
Balance
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 23
Sex: MALE
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block Randomized controlled study
Primary purpose: TREATMENT

Brief summary: The progressive muscle weakness and contractures of the patients adversely affect their gait and balance. It is known that the disorder of the patients' balance and gait affects their functional capacity. The aim of this study is to examine the effects of bicycle ergometer training on gait and balance in children with Duchenne Muscular Dystrophy. Twenty-four children with DMD included in the study will be divided into two groups as home program and home program+bicycle ergometer training with block randomization method. Home program including stretching, respiratory, range of motion, posture and mild resistance exercise with body weight will be asked to apply 3-5 days a week for 12 weeks, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes total duration consisting of 5 min warm up and 5 min cool down period. Gait and balance were evaluated with GAITrite and Bertec Balance Check Screener, successively. Assessments will be applied at pre-training and after 12 weeks of training.


Eligibility criteria: Inclusion Criteria:

* Children have diagnosis of DMD confirmed by genetic analysis,
* Children can walk with unsupported.

Exclusion criteria:

* Children have undergone any surgery or suffered injury of the lower limbs,
* Children have severe contractures of lower limbs,
* Children have low cooperation
* Children have comorbid disease,
* Children were applied regular aerobic training such as bicycle training and hydrotherapy in last 6 months.

Primary outcomes:
measure: Step Time and Cycle Time(Gait)
timeFrame: 5 minutes
measure: Step Length, Stride Length and base of support (Gait)
timeFrame: 5 minutes
measure: Single support, double support, swing phase and stance phase (Gait)
timeFrame: 5 minutes
measure: Velocity (Gait)
timeFrame: 5 minutes
measure: Cadence (Gait)
timeFrame: 5 minutes
measure: Balance (rigid surface)
timeFrame: 10 minutes
measure: Balance (perturbated surface)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
state: Altındağ
Study officials:
References:
Clinical trial NCT04749095: Erector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery
Official title: Can Bilateral Erector Spinae Plane Block Minimize Perioprative Opioid Consumption and Provide Satisfactory Analgesia for Lumbar Spine Fusion Surgery? A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study was to investigate the effect of a bilateral ultrasound guided erector spinae plane block on the pain scores and opoid utiliziation in fusion surgery of the lumbar spine.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists class I-III adult patients
* BMI less than or equal 35 kg/m2

Exclusion Criteria:

* Patient refusal
* unable to give consent
* age \< 18 or \> 65
* BMI more than 35 kg/m2
* known allergy to the study medication
* coagulopathies or on anticoagulant medications
* hepatic insufficiency
* renal insufficiency
* chronic opioid use

Primary outcomes:
measure: Analgesia
timeFrame: Up to 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05686395: Pain Control After Arthroscopic Shoulder Surgeries
Official title: Comparative Study of Analgesic Efficacy of Ultrasound Guided Interscalene Block Versus Combined Shoulder Anterior Capsular Block and Suprascapular Nerve Block for Arthroscopic Shoulder Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to compare the perioperative analgesic efficacy of ultrasound - guided interscalene brachial plexus block versus combined shoulder anterior capsular block and anterior suprascapular nerve block for arthroscopic shoulder surgeries.


Eligibility criteria: Inclusion Criteria:

* Patients aged 20-65 years of both sexes, with American Society of Anesthesiologists (ASA) physical status I or II admitted for arthroscopic shoulder surgery.

Exclusion Criteria:

* Patient refusal.
* Uncooperative patient.
* Patient with neurological deficit.
* Patients with respiratory disorders.
* Patient with bleeding disorders.
* Infection at the block injection site.
* Patients with history of allergy to local anesthetics.

Primary outcomes:
measure: post operative analgesic consumption
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Visual Analogue score (VAS) in the first 24 hours after surgery
timeFrame: first 24 hours after surgery
measure: Patient satisfaction score
timeFrame: first 24 hours after surgery
measure: The incidence of hemi diaphragmatic paralysis
timeFrame: immediately before block and immediately after procedure
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine Tanta University
Study officials:
References:
Clinical trial NCT06127095: A Study to Assess New Participant's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based Relapsing Remitting Multiple Sclerosis (RRMS) Treatments
Official title: New perSEPtion. New Patient's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based RRMS Treatments.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with RRMS who have been prescribed natalizumab (Tysabri®) whether injected IV or SC, ocrelizumab (Ocrevus®), or ofatumumab (Kesimpta®) under standard clinical care for more than 6 months.

Brief summary: The primary objective of the study is to understand what the added value of natalizumab (Tysabri®) treatment is from a participant's perspective at a given time, based on a one-shot survey. The secondary objectives of the study also aim to characterize the participant's decision-making process to get the treatment; the burden of treatment, characterization of the study population, assessment of the quality of life (QoL), and fatigue dimension.


Eligibility criteria: Inclusion Criteria:

• Participants diagnosed with RRMS and followed by a neurologist in France.

Exclusion Criteria:

• Lack of literacy

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants who Perceived the Treatment Added Value of Natalizumab Assessed by Likert's Scale
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants who Perceived Burden of Treatment Assessed by Closed and Open-ended Questions
timeFrame: Day 1
measure: Number of Participants With Perceived Decision-making Process Assessed by Likert's Scale
timeFrame: Day 1
measure: Number of Participants With Perceived Decision-making Process Assessed by Open-ended Questions on Quality of Life (QOL)
timeFrame: Day 1
measure: Number of Participants Characterized by Multiple Sclerosis (MS) Types
timeFrame: Day 1
measure: Number of Participants Characterized by MS Duration
timeFrame: Day 1
measure: Number of Participants Characterized by Current Disease Modifying Treatment (DMT)
timeFrame: Day 1
measure: Mean Multiple Sclerosis International Quality of Life Questionnaire (MusiQol) Score
timeFrame: Day 1
measure: Mean Fatigue Severity Scale (FSS) Score
timeFrame: Day 1
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Biogen
state: Massachusetts
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06315595: Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion and Non-Contrast MRI
Official title: Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion and Non-Contrast MRI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2024-03-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult male volunteers as well as Mayo patients for whom a prostate MRI exam has been clinically indicated and ordered. In some cases such as for evaluation of the vasculature of the pelvis it may be useful to extend the inclusion criteria of volunteers to adult females.

Brief summary: This study evaluates if technical improvements in MRI can be used to provide improved performance contrast-enhanced MRI as used for angiography and perfusion as well as in non-contrast MRI.

Detailed description: PRIMARY OBJECTIVE:

I. To study how a variety of technological approaches in MRI can be used to provide improved performance contrast-enhanced MR imaging as used for angiography and perfusion as well as in MR image acquisition without the use of contrast material.

OUTLINE: This is an observational study.

Participants undergo a non-contrast MRI on study and may optionally undergo a second non-contrast MRI on study. Participants may also undergo blood sample collection on study.

Eligibility criteria: Inclusion Criteria:

* Adults

Exclusion Criteria:

* Standard exclusion criteria for clinical MRI; e.g. cardiac pacemaker, claustrophobia, an implanted device that has been determined to be MR conditional at 1.5T but not at 3T, anticipated considerable susceptibility artifact from hip prosthesis, etc.

Primary outcomes:
measure: Improved performance in contrast-enhanced magnetic resonance imaging (MRI) as used for angiography and perfusion
timeFrame: Baseline (at enrollment); possible second scan at a later date
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Stephen J. Riederer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05824195: Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic Test Variables
Official title: Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic- and Cognitive Test Variables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Diet, Healthy
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The overall goal is to increase the knowledge that can be used for the development of food products with antidiabetic properties, with the aim of facilitating healthier food choices for people. More specifically, the primary aim of this project is to evaluate the effects of different varieties of quinoa on postprandial glucose tolerance and subjective appetite markers. The crossover, randomised dietary intervention study will be conducted in healthy adults.


Eligibility criteria: Inclusion Criteria:

* BMI of 20-28
* age between 18-40 years
* Healthy
* consume a diet in accordance with Nordic Nutrition Recommendations

Exclusion Criteria:

* not vegan
* metabolic diseases (such as diabetes)
* Gastro intestine tract problems or irritable bowel syndrome
* known food allergies of intolerances
* smoker
* antibiotics should not have been consumed during the last 4 weeks
* probiotics should not have been consumed during the last 4 weeks

Primary outcomes:
measure: Glucose tolerance
timeFrame: 3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Secondary outcomes:
measure: serum insulin
timeFrame: 3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
measure: Subjective appetite sensations (hunger, satiety, and desire to eat)
timeFrame: 3 hours. Fasting (time =0 minutes), 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University, dep of Food Technology, Engineering, and Nutrition
state: Välj...
Study officials:
References:
Clinical trial NCT03316495: IMPACT OF PAMPHLET ON THE KNOWLEDGE OF HEALTH EFFECT OF SMOKING
Official title: IMPACT OF PAMPHLET ON THE KNOWLEDGE OF HEALTH EFFECT OF SMOKING: A RANDOMISED CLINICAL TRIAL.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Lead sponsor: University of Benin
Sponsor class: OTHER
Collaborators: name: UBTH
First posted: 2017-10-20
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Tobacco smoke is one of the most preventable cause of mortality and morbidity worlwide, this study is conducted to compare the knowledge of the health effects of smoking among undergraduates exposed and those not exposed to educational pamphlet. This is designed as a randomized clinical trial among 390 undergraduate in University of Benin Edo State Nigeria. Data collection tool was an interviewer-administered questionnaire. Data obtained would be subjected to regression statistics using IBM SPSS version 21.0. The expected outcome will be a veritable tool in tobacco cessation model.


Eligibility criteria: Inclusion Criteria:

- HEALTHY

Exclusion Criteria:

* NOT CONSENTING

Primary outcomes:
measure: KNOWLEDGE OF HEALTH EFFECT OF SMOKING
timeFrame: 7 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Benin City
country: Nigeria
facility: Clement Chinedu Azodo
state: Edo State
Study officials:
References:
Clinical trial NCT02102295: Effects of Antioxidant Dentifrice on Gingivitis
Official title: Clinical Study of an Ascorbic Acid Derivative Dentifrice in Patients With Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Keywords: Gingivitis
antioxidant
dentifrice
Ascorbic Acid Derivative
L ascorbic acid 2 phosphate magnesium salt
Lead sponsor: Lion Corporation
Sponsor class: INDUSTRY
Collaborators: name: Osaka University
name: Tohoku University
name: Nihon University
First posted: 2014-04-02
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of a dentifrice containing L-ascorbic acid 2-phosphate magnesium salt on gingival inflammation, gingival bleeding and gingival redness.


Eligibility criteria: Inclusion Criteria:

* Age between ≥ 20 and \< 65 y with at least 16 permanent teeth.
* Gingival inflammation or mean baseline GI ≥ 0.5 without severe periodontal disease enough to require professional therapy.
* Written informed consent to participate.

Exclusion Criteria:

* Taking medications that could influence periodontal tissue health, such as antimicrobials and antihypertensives within 1 month before starting the trial.
* Use of orthodontic appliances.
* Pregnancy or planning to become pregnant during the trial period.
* Previous participation in any other clinical trial.
* Inability of patient to understand the study purpose and/or study protocols.
* Judged unsuitable by investigators for other reasons.

Primary outcomes:
measure: Gingival Index
timeFrame: 3 months
Secondary outcomes:
measure: Gingivitis Severity Inedex
timeFrame: 3 months
measure: Gingival Redness
timeFrame: 3 months
Other outcomes:
measure: salivary antioxidant status
timeFrame: 3 months
Locations:
city: Matsudo
country: Japan
facility: Nihon University Hospital, School of Dentistry at Matsudo
state: Chiba
city: Sendai
country: Japan
facility: Tohoku University Dental Hospital
state: Miyagi
city: Suita
country: Japan
facility: Osaka University Dental Hospital
state: Osaka
city: Chiyoda-ku
country: Japan
facility: Nihon University Dental Hospital
state: Tokyo
Study officials:
affiliation: Osaka University
name: Shinya Murakami
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shimabukuro Y, Nakayama Y, Ogata Y, Tamazawa K, Shimauchi H, Nishida T, Ito K, Chikazawa T, Kataoka S, Murakami S. Effects of an ascorbic acid-derivative dentifrice in patients with gingivitis: a double-masked, randomized, controlled clinical trial. J Periodontol. 2015 Jan;86(1):27-35. doi: 10.1902/jop.2014.140138.