How does orthodontic pain differ in patients using fixed appliances versus those using clear aligner therapies?

Researchers have found in a new study that the intensity of orthodontic pain in that fixed appliance versus those who use clear aligner therapies is the same in the initial 2 days of treatment. However, after two days those using clear aligners reported a low rate and intensity of pain whereas for those using fixed appliances pain peaked after 2 days touching baseline within a week. The study results have been published in the American Journal of Orthodontics and Dentofacial Orthopedics.

This prospective study compared pain perception, intensity, and analgesic use among patients treated with fixed appliances (FAs) and clear aligners (CAs) over 6 months. Digital surveys were collected from 87 adult patients treated with CA or FA from 2 orthodontic offices. The 7-item survey was sent at 3-time points (preappointment, 2-day postappointment, and 7-day postappointment) for each appointment. Wilcoxon, t test, and Fisher exact chi-square tests were performed with significance set at 0.05. Results: The FA group had a higher rate and intensity of pain 2 days after the second, third, and fifth appointments (P <0.030). At 7 days postappointment, the FA group had a higher rate and intensity of pain for the first and fifth appointments. Dull pain was reported the most in both groups, with a proportion of FA patients reporting throbbing (31%) or sharp (20%) pain (P = 0.035) at 2 days postappointment. The CA group reported the most pain at rest, whereas the FA group reported chewing as the most painful (P = 0.002). The FA group had a higher rate of analgesic consumption after the first appointment (P = 0.037). Both the FA and CA groups experienced similar rates and intensities of pain 2 days after the delivery of appliances at the first appointment. Although CA pain intensity remained minimal, FA pain peaked 2 days postappointment whenever a new orthodontic stimulus was introduced and remained elevated 7 days postappointment when that stimulus was a new archwire material.

Reference:

Chan V, Shroff B, Kravitz ND, Carrico C, Hawkins D, Tran P, Lindauer S. Orthodontic pain with fixed appliances and clear aligners: A 6-month comparison. Am J Orthod Dentofacial Orthop. 2024 Jul 30:S0889-5406(24)00271-3. doi: 10.1016/j.ajodo.2024.07.002. Epub ahead of print. PMID: 39078353.

Keywords:

orthodontic, pain, differs, patients, fixed, appliance, use, clear, aligner, therapies, American Journal of Orthodontics and Dentofacial Orthopedics, Chan V, Shroff B, Kravitz ND, Carrico C, Hawkins D, Tran P, Lindauer S. Orthodontic pain

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AstraZeneca Gets CDSCO Panels Nod to study anticancer drug AZD0901

New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial of the anti-cancer drug AZD0901 powder for solution for infusion.

This came after AstraZeneca presented Phase III clinical study protocol No. D9802C00001 version 1.0 dated 13 October 2023. The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator’s choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

AZD0901 is a drug being developed by AstraZeneca to treat advanced solid tumors, such as pancreatic cancer, gastric cancer, and adenocarcinoma of the gastroesophageal junction.

AZD0901 specifically targets and binds to CLDN18. 2 expressed on tumor cells. Upon internalization and the release of MMAE, MMAE targets and binds to tubulin, and inhibits microtubule polymerization. This results in G2/M phase cell cycle arrest and apoptosis in CLDN18.

At the recent SEC meeting for Oncology held on 9th October 2024, the expert panel reviewed the Phase III clinical study protocol No. D9802C00001 version 1.0 dated 13 October 2023.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.

Also Read: CDSCO prioritizes transparency, digitizes more than 95% regulatory processes

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18 formulations declared Not of Standard Quality as per data provided by states: CDSCO Drug Alert

New Delhi: In line with the ‘Not of Standard Quality’ data provided by states, the Central Drug Standard Control Organisation (CDSCO), in its recent drug safety alert, has flagged eighteen medicine batches for failing to qualify for a random sample test for September 2024.

The list of drugs declared not of standard quality include Moxica -250 [Amoxicillin Dispersible Tablets IP 250 mg manufactured by Indica Pharma, Neurotem-NT manufactured by Catasta Pharma, Loperamide Hydrochloride Tablets IP (JKMSCL Hospital Supply) manufactured by Karnani Pharma, Wintel 40 Tablets, Panlib 40 Tablets manufactured by Himalaya Meditek. 

The list further includes Telmisartan Tab IP 40 mg, Pantoprazole Inj.BP 40 mg, Glimepiride Tab IP, Cough Syrup manufactured by Kerala Medical Services.

B. State Laboratories

S.No

Product/Drug

Name

Batch No.

Manufacturing

Date

Expiry

Date

Manufactured By

NSQ Result

Reported by

CDSCO Laboratory

1.

Neurotem-NT

CPT-2698

Mar-24

Feb-26

Catasta Pharmaceuticals Plot No. 113, DIC,

Industrial Area, Baddi Distt. Solan (H.P)

Mrk. By : Cosway Biosciences Coprporate Office : Khasra No.

2054/1724, 1725 SCO No.

11 Baddi Barotiwala Road The. Baddi Distt. Solan H.P 173205

The given Drug Sample does not comply to the contents of Assay with respect to Pregabalin ( 23.26% of

claim)

Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024- 25/1191

Dated: 05.09.2024.

(Report attached as Annexure A)

2.

Cefuroxime Axetil Tablets IP 500 mg (JKMSCL Supply)

JAK-23

Jul-23

Jun-25

Agron Remedies Pvt Ltd Sarverkhera Moradabad Road Kashipur 244 713 (Uttarakhand)

The sample fails in the Description, Dissolution and Assay of Cefuroxime Axetil w.r.t the sample portion received as

above

Combined Food & Drug Testing Laboratory Jammu (J&K) vide report on Form 13 bearing No.

CFDL/J/2024-25/1120 Dated: 26.09.2024.

(Report attached as Annexure B)

3.

Loperamide Hydrochloride Tablets IP (JKMSCL Hospital Supply)

T-16201

May-24

Apr-26

Karnani Pharmaceuticals Pvt. Ltd , 38 Pharma City , Selaqui Dehradun -248011

The sample does not conform to IP with respect to the test for Dissolution & Assay

Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024-25/1311 Dated: 27.09.2024.

(Report attached as Annexure C)

4.

Floxages-OZ (Ofloxacin and Ornidazole Tablets IP)

SPY41223

12/23

11/26

Suraksha Pharma pvt.Ltd, 410, Karondi, Roorkee-247

667, Uttarakhand

It fails the test ‘Dissolution’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

5.

Wintel 40 Tablets

HTN257D

04/24

03/26

Himalaya Meditek pvt.Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun –

248 197

It fails the test ‘Dissolution’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

6.

Moxica -250 [Amoxicillin Dispersible Tablets IP 250 mg]

SD 243

08/23

07/25

Indica Pharmaceuticals (P) Ltd, Bapunagar, Ahmedabad- 382 345

It fails the test ‘Disintegration’ and ‘Uniformity of Dispersion’ specified in the Laboratory Protocol as per

IP

Drugs Testing Laboratory Thiruvananthapuram

7.

Frusemide Injection IP 20 mg

FRIB-03

01/24

12/25

Nestor Pharmaceuticals

Ltd, 11, Western Extension Area, Faridabad -121001

It fails the test

‘Sterility’ as per IP

Drugs Testing

Laboratory Thiruvananthapuram

8.

Cloxacillin Sodium Capsules IP 250 mg

CLCA-04

04/23

03/25

Nestor Pharmaceuticals Ltd, 11, Western Extension Area, Faridabad -121001

The sample does not conform to IP Standards with respect to ‘Descriptive part’ of hard gelatin capsules and further tests cannot be performed due to reasons secified in the

laboratory protocol

Drugs Testing Laboratory Thiruvananthapuram

9.

Fluorometholone Eye Drops IP

CHE-3044

05/23

04/25

Cotec Healthcare pvt.Ltd, K.H.No.593/1, Roorkee, Dehradun Highway, Kishanpur, Roorkee- 247

667, UK

It fails the test ‘Uniformity of Volume’ and ‘Assay’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

10.

Panlib 40 Tablets

HTN 102A

01/24

12/25

Himalaya Meditek pvt.Ltd, Plot No. 35 & 36,

Pharmacity, Selaqui, Industrial Area, Dehradun

It fails the test Dissolution’ and

‘Assay’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

11.

B – Cidal 625

UT232859

03/24

08/25

VADSP Pharmaceuticals, Plot No. 124, EPIP

Indl.Area, Phase 1, Jharmajri, Baddi (HP)- 174103

The content of Clavulanic acid is not with in the limit of ‘Schedule V’ of Drugs and Cosmetics Act & Rules

thereunder

Drugs Testing Laboratory Thiruvananthapuram

12.

Trypsin, Bromelain & Rutoside Trihydrate Tablets [Flavoshine]

TTF24065

06/24

11/25

Tiruvision Medcare, Plot No. 177, HPSIDC,

Indl.Area, Baddi, Dist Solan HP 173 205

The sample fails the test ‘Disintegration’ specified in the Laboratory protocol as per

IP

Drugs Testing Laboratory Thiruvananthapuram

13.

C Mont LC Kid 60 ml (Montelukast & Leveocetirizine Dihydrochloride syrup)

AL 23206

11/23

10/25

Cian Healthcare Ltd, kh No.248, Village sisonia, Bhagwanpur, Roorkee, Haridwar, Uttarakhand- 247

661

The content of montelukast is not within the limits of Schedule ‘V’ of Drugs & Cosmetics Act &

Rules

Drugs Testing Laboratory Thiruvananthapuram

14.

Yogaraja Guggulu Tablet

P 592324

10/23

09/26

Oushadhi, The Pharmaceutical corporation (IM) , Kerala Ltd, Kuttanellur, Thrissur- 68

0014

The sample does not conform to API Standards. It fails the tests ‘Total Ash’ as

per API Standards.

Drugs Testing Laboratory Thiruvananthapuram

15.

Telmisartan Tab IP 40 mg

D1153/24-25

Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14

The sample does not conform to IP Standards with respective to ‘Descriptive part’ of tablets and further tests cannot be performed due

to above reasons.

Drugs Testing Laboratory Thiruvananthapuram

16.

Pantoprazole Inj.BP 40 mg

D 0923/24- 25

Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14

It fails the test ‘Sterility’ specified in the laboratory

protocol as per IP

Drugs Testing Laboratory Thiruvananthapuram

17.

Glimepiride Tab IP

D1272/24-25

Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14

The sample fails the descriptive part for tablets as they are not sufficiently hard to withstand handling without crumbling or breaking and further tests cannot be performed due

to above reason

Drugs Testing Laboratory Thiruvananthapuram

18.

Cough Syrup

D 1278/24- 25

Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14

The sample fails the ‘Descriptive part’ for oral dosage forms of Schedule V of drugs and cosmetics Act

and Rules, as the syrup contains red coloured

suspended paticles

Drugs Testing Laboratory Thiruvananthapuram
For more details, check out the full story on the link below:
https://medicaldialogues.in/pdf_upload/state-nsq-alert-for-the-month-of-sept-2024-258534.pdf

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Sun Pharma Winlevi cream 1% reduces Sebum levels, suitable for combination with other commonly used topical acne medications: Study

Mumbai: Sun Pharmaceutical Industries Limited has presented data strengthening the clinical rationale for the use of WINLEVI (clascoterone) cream 1% to treat acne.

In poster presentations at the 44th Annual Fall Clinical Dermatology
Conference, data show WINLEVI significantly reduces sebum (oil) production and demonstrates excellent stability
in the presence of other commonly prescribed topical acne treatments, supporting the use of WINLEVI in
combination with those medications. Data also showed patients with skin of color, an under-represented population
in studies of acne medications, experienced reduced acne severity and tolerability while taking WINLEVI.
Collectively, the data continue to show that WINLEVI improves acne severity and is well tolerated.

WINLEVI is a androgen receptor inhibitor indicated for the topical treatment of acne vulgaris (acne)
in patients 12 years of age and older, and the first and only FDA-approved topical treatment available in the U.S. that
targets sebum production in the skin.

Sebum is an oily wax that protects and moisturizes skin, but too much of it
feeds bacteria inside the skin, causing inflammation and acne lesions. Acne is the most prevalent skin condition in
the U.S., affecting up to 50 million Americans and 80% of people at some point during their lives. It is the most
common dermatological disorder in Black/African American and Hispanic/Latino populations. WINLEVI cream is a topical prescription medicine to treat acne in people 12 and older.

Researchers presented 12-week interim results from a yearlong study of the effect of WINLEVI on facial sebum
production in patients with acne. The study’s primary objective and efficacy endpoint was reduction in casual facial
sebum levels, as measured by a sebumeter, a device that directly measures the amount of lipids on the skin’s surface.
The study was also designed to assess the ability of WINLEVI to reduce the Investigator’s Global Assessment (IGA)
score, a scale designed for investigators to assess the level of facial acne (0 = clear, 1 = almost clear, 2 = mild, 3 =
moderate, 4 = severe). Other study objectives and efficacy endpoints included inflammatory and noninflammatory acne lesion counts, and investigator-assessed oily appearance, pore size, and facial shine; the latter three endpoints
were assessed on a five-point scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe).
Among the 40 participating patients, the mean age was 20.9 years; most patients were female (60%) and White
(63%). All patients entered the study with mild (57.5%) or moderate (42.5%) acne, as well as a mean sebumeter
reading of 115.9 ± 50.5.
The researchers reported significant reductions in sebumeter measurements following use of WINLEVI at six (-22%,
P = 0.002), 10 (-19%, P = 0.005), and 12 weeks (-27%, P <0.001). They also observed significant improvements in
facial oily appearance after four weeks of WINLEVI treatment (-8%, P = 0.008), with continued improvement
through 12 weeks (-40%, P <0.001). Similarly, patients’ pore size improved significantly after six weeks (-13%, P =
0.002), and continued to improve through 12 weeks (-23%, P <0.001). Additionally, facial shine levels significantly
improved after four weeks (-9%, P = 0.004) with continued improvement through 12 weeks (-39%, P <0.001).
By Week 12, patients using WINLEVI experienced a statistically significant 29% reduction in IGA score (P <0.001).
Use of WINLEVI also resulted in significant reductions in the numbers of inflammatory and noninflammatory lesions
(-48% and -40%, respectively; P <0.001 for both measurements) after four weeks, with continued improvement
through 12 weeks (-54% and -34%, respectively; P <0.001 for both). WINLEVI was well tolerated through Week 12,
with no reports of adverse reactions.


“This is exciting news for people living with acne because this is the first study to demonstrate a reduction in
measured facial sebum production following the use of clascoterone cream 1%,” said lead investigator Zoe D.
Draelos, MD, of Dermatology Consulting Services, PLLC, in High Point, N.C. “In addition to confirming the sebumreducing effect of WINLEVI, our findings support data from previous clinical trials which showed reductions in the
number of inflammatory and noninflammatory lesions, further demonstrating the clinical utility of this topical acne
medication.”


Stability in combination therapy data
Dr. Draelos and colleagues also reported results from a study assessing the stability of WINLEVI when layered with
other topical acne medications such as tretinoin cream 0.025%, adapalene gel 0.3%, dapsone gel 7.5%, azelaic acid
15%, benzoyl peroxide 5%/clindamycin 1%, benzoyl peroxide 2.5%/adapalene 0.1%, and benzoyl peroxide
encapsulated 5%. Each of these medications were placed separately on individual microscope slides with WINLEVI
and incubated for eight hours at 37° Celsius. Material from the slides was extracted for analysis via high-performance
liquid chromatography-mass spectrometry (HPLC-MS).

WINLEVI concentrations remained stable after layering with other acne medications. The percentage of WINLEVI
recovered after layering ranged from 98% to 119%, indicating that none of the acne medications evaluated induced
degradation of WINLEVI when used in combination.
“Multimodal topical therapy, incorporating products with multiple mechanisms of action to target multiple
mechanisms of disease, has become standard practice in the treatment of acne,” commented Dr. Draelos. “In this in
vitro study, WINLEVI demonstrated consistent and reproducible stability in the presence of other acne medications.
Our findings support the combination of WINLEVI with topical retinoids, topical antibiotics, and/or benzoyl peroxide
as a viable acne treatment strategy and complement the encouraging results observed in the sebum reduction and skin
of color trials.”
A separate team of researchers presented 16-week interim results from a 56-week, single-center, open-label pilot
study evaluating the efficacy and safety of WINLEVI in 10 patients (mean age 24 years) with skin of color
(Fitzpatrick skin types IV, V, and VI) and moderate-to-severe facial acne. The study met its primary endpoint, with
seven (78%) patients achieving an IGA score of 0 (clear) or 1 (almost clear) at Week 16 (P = 0.008 vs. baseline). The
study also met its secondary endpoints at Week 16, including significant reductions in inflammatory (91.8%, P =
0.008), noninflammatory (90.9%, P = 0.009), and total lesions (90.9%, P = 0.009). Investigator- and participantassessed tolerability parameters were absent or minimal at most time points through Week 16. There were no reports
of adverse events during the 16-week interim analysis period

Read also: Sun Pharma presents Leqselvi data highlighting clinical efficacy, durability for Alopecia Areata treatment at 2024 Fall Clinical Dermatology Conference

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From concert piano to fear memory research, researcher bridges mouse-human studies

In a new interview published in Brain Medicine, Dr. Raül Andero Galí reveals how his early passion for classical piano shaped his unique approach to neuroscience research. As an ICREA Research Professor at the Autonomous University of Barcelona, Dr. Andero Galí leads groundbreaking studies that connect mouse and human fear responses, potentially revolutionizing treatments for PTSD and anxiety disorders.

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Scientists develop tool to predict sepsis in apparently healthy newborns

A genetic signature in newborns can predict neonatal sepsis before symptoms even start to show, according to a new study.

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Synthetic vitamin K precursor found to slow progression of prostate cancer in lab mice

A team of molecular biologists and other medical specialists at Cold Spring Harbor Laboratory in New York, working with a large number of international partners, reports evidence that a synthetic vitamin K precursor can be used to slow the progression of prostate cancer in lab mice.

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Don’t skip colonoscopy for new blood-based colon cancer screening, study says

Newly available blood tests to screen for colorectal cancer sound far more appealing than a standard colonoscopy. Instead of clearing your bowels and undergoing an invasive procedure, the tests require only a simple blood draw. But are the tests effective?

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Genetic risk factor for kidney disease identified in West African populations

A study by researchers at the National Institutes of Health (NIH) and their collaborators has revealed a significant genetic risk factor for kidney disease in people from Ghana and Nigeria. Their study demonstrated that having just one risk variant in a gene known as APOL1 can significantly increase the risk of developing kidney disease. APOL1 is important for the immune system, and variants of the gene are linked to an increased risk of chronic kidney disease.

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550 vacant posts in Government Medical Colleges: Bombay HC Orders Continuous Recruitment to Fill Vacancies

Nagpur: The alarming situation regarding faculty positions at government medical colleges (GMCs) across Vidarbha has come to light, revealing a total of 550 vacant posts for professors, associate professors, and assistant professors. The issue was highlighted on Thursday, during the suo motu PIL at the Nagpur bench of the Bombay High Court.

The High Court pointed out that although there is a system in place to fill these posts six months before a vacancy arises, the state has allowed a significant number of positions to remain vacant.

Also Read:50 percent Faculty, 66 percent Resident Doctors shortage at Telangana Medical Colleges: NMC

The division bench of Justices Avinash Gharote and M.S. Jawalkar expressed concerns over the list of vacancies, indicating a very dismal picture. They warned that this situation could have a cascading effect on the quality of medical assistance provided to patients in these government medical colleges. The Directorate of Medical Education and Research (DMER) represented by senior counsel Firdos Mirza, submitted a list comprising vacancies of 76 professors, 116 associate professors, and 358 assistant professors in these GMCs. Notably, the specifics of the vacancies per college were kept confidential.

The state government and the Directorate of Medical Education and Research (DMER) have been assigning additional charges to existing faculty instead of appointing permanent staff for an extended period. To address the staffing shortage ahead of National Medical Commission (NMC) inspections, doctors are being deputed to government medical colleges (GMCs) that are lacking in staff to “meet the norms.” Nagpur, home to some of the oldest medical colleges like IGGMCH and GMCH, continues to face persistent staff shortages, while newer colleges in other districts often lack even full-time deans.

Notably, admissions in the new GMCs at Hinganghat, Washim, and Buldhana are not yet allowed, meaning these colleges cannot be considered fully functional. This limitation is believed to be the reason that the vacancies are primarily from the GMCs in the rest of the eight districts.

In Gondia, most of the teaching posts are still vacant or on a contract basis since the inception of the college and the addition of newly approved colleges, the situation has not improved as all the posts are either on a deputation basis or vacant. Currently, all new colleges have a dean on an additional charge which is violating the guidelines of the GR dated September 5, 2018.

At the Government Medical College and Hospital (GMCH) in Nagpur, the recent transfer of four associate professors of medicine has created vacancies, resulting in the loss of eight out of 37 postgraduate seats. Projections suggest that this number could drop further to 21 seats next year.

Also Read: New Medical Colleges opened, but who will teach? Maha doctors decry faculty shortage

As per the recent media report by TOI, the HC noted that although some posts have been occupied by persons on contract, that does not serve the purpose of providing quality education to the students. “No reason is forthcoming as to why these vacancies are not being filled on a permanent basis as these are sanctioned vacancies. However, the issue needs to be addressed on an urgent basis, as quality education needs to be imparted to the students,” the HC said.

The court has instructed the state government and the Directorate of Medical Education and Research (DMER) to submit a mechanism by November 13 that ensures continuous filling of vacancies as they occur.

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