Multiple-enzymes lozenge may be an adjunct to regular mechanical plaque removal , suggests

Multiple-enzymes lozenge may be an adjunct to regular mechanical plaque removal, as suggested by a study published in the Journal of Dentistry.

A study was done to evaluate the effect of daily use of a multiple-enzyme lozenge on de novo plaque formation, on gingivitis development, and on the oral microbiome composition. This trial with two parallel arms included 24 healthy adults allocated to the Active (n = 12) or Placebo (n = 12) group. Subjects consumed one lozenge three times daily for seven days, and no oral hygiene procedures were allowed. Differences in de novo plaque accumulation between a baseline period, and one and seven days of intervention were assessed by the Turesky-modification of the Quigley-and-Hein-Plaque-Index (TM-QHPI). The development of gingivitis after seven days of intervention was assessed by the Gingival Index (GI). Plaque and saliva samples were collected at baseline and after seven days of intervention, and evaluated by 16S rRNA gene sequencing. Results: All subjects completed the study, and no adverse events were reported. After one day, the average TM-QHPI was significantly lower in the Active than in the Placebo group, as compared to baseline (p = 0.012). After 7 days, average TM-QHPI values did not differ significantly between groups (p = 0.37). GI values did not increase during the intervention period, with no difference between groups (p = 0.62). Bacterial richness increased in both plaque and saliva samples over a seven-day oral hygiene-free period, with a statistically significant difference for the saliva samples (p = 0.0495) between groups. A multiple-enzymes lozenge decreased the build-up of de novo plaque after one day and slowed down the process of species increment in saliva. The lozenge may be an adjunct to regular mechanical plaque removal. Dental plaque is the main cause of caries, gingivitis, and periodontitis. The search for therapeutic adjuncts to mechanical plaque removal that have no harmful effects on the oral microbiome is important. Treatment with multiple plaque-matrix degrading enzymes is a promising non-biocidal approach to plaque control.

Reference:

Sebastian Schlafer, Karina K. Johnsen, Inge Kjærbølling, Andreas Schramm, Rikke L. Meyer, Mette Rose Jørgensen. The efficacy and safety of an enzyme-containing lozenge for dental biofilm control—a randomized controlled pilot trial. Journal of Dentistry, Volume 147,

2024, 105107, ISSN 0300-5712. https://doi.org/10.1016/j.jdent.2024.105107.

Keywords:

Multiple-enzymes, lozenge, adjunct, regular, mechanical, plaque removal, Beta-glucanase; Dental plaque; Dental plaque index; Desoxyribonuclease; Mutanase; Oral hygiene, Journal of Dentistry

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No Increased Risk of Preterm Delivery with Cervical Dilatation in First Trimester Pregnancy Loss Curettage Procedure: Study

Israel: A recent retrospective comparative study has delved into the potential effects of first-trimester mechanical cervical dilatation during curettage on maternal and neonatal health outcomes.

The study, published in the European Journal of Obstetrics & Gynecology and Reproductive Biology, showed no additional risk of preterm delivery with the use of cervical dilatation during a curettage procedure for first-trimester pregnancy loss.

During early pregnancy, curettage—a procedure involving the removal of tissue from the uterus—is sometimes performed to manage conditions such as miscarriage or incomplete abortions. Mechanical cervical dilatation, a common practice to facilitate access to the uterus during these procedures, has raised questions regarding its impact on pregnancy outcomes.

Previous research has suggested a possible association between dilatation and curettage (D&C) and an increased risk of preterm delivery, potentially due to cervical trauma. Tal Margaliot Kalifa, Department of Obstetrics & Gynecology, Shaare Zedek Medical Center, Affiliated with the Hebrew University School of Medicine, Jerusalem, Israel, and colleagues aimed to examine outcomes in pregnancies after first-trimester curettage with and without cervical dilatation.

For this purpose, the researchers conducted a retrospective cohort study on women who conceived after undergoing curettage due to a first-trimester pregnancy loss. The study compared maternal and neonatal outcomes in subsequent pregnancies between two groups: women who underwent cervical dilatation before their curettage and those who underwent curettage without prior dilatation.

The main focus of the study was to determine the rate of preterm delivery in subsequent pregnancies as the primary outcome, with secondary outcomes encompassing other adverse maternal and neonatal conditions. Initial analysis involved univariate assessment, followed by the application of multiple logistic regression models to compute adjusted odds ratios (aORs).

The following were the key findings of the study:

· Among the 1087 women meeting the inclusion criteria during the study period, 852 underwent first-trimester curettage with cervical dilatation, while 235 opted for curettage only.

· No significant maternal or neonatal different outcomes were noted between the study groups, including preterm delivery (5.5 % versus 3.5 %), fertility treatments, placental complications, and mode of delivery.

· Deliveries following D&C were associated with higher rates of small for gestational age neonates (7.6 % versus 3.8 %).

· Multivariate analysis revealed that cervical dilation before curettage was not significantly linked to preterm delivery [adjusted odds ratio 0.64].

“Cervical dilatation use during a curettage procedure for first-trimester pregnancy loss does not confer additional risk of preterm delivery. There is a need for further studies to reinforce and validate these results,” the researchers concluded.

Reference:

Margaliot Kalifa, T., Srebnik, N., Sela, H. Y., Armon, S., Grisaru-Granovsky, S., & Rottenstreich, M. (2024). Impact of first-trimester mechanical cervical dilatation during curettage on maternal and neonatal outcomes: A retrospective comparative study. European Journal of Obstetrics & Gynecology and Reproductive Biology. https://doi.org/10.1016/j.ejogrb.2024.06.040

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Study Links Maternal Hypertensive Disorders to 82 Percent Higher Risk of Childhood Strabismus

China: A cohort study of 3117 children revealed an 82% higher overall risk of strabismus at three years of age in offspring born to mothers with hypertensive disorder of pregnancy (HDP). Furthermore, the highest risk was observed in offspring with maternal preeclampsia and poorly controlled blood pressure (BP).

The findings, published in JAMA Network Open, suggest that early strabismus screening might be recommended for offspring born to mothers with HDP, particularly those with maternal preeclampsia or poorly controlled BP.

Maternal health during pregnancy has long been recognized as a crucial factor influencing the long-term health outcomes of offspring. Strabismus, commonly known as crossed eyes or squint, is a condition where the eyes do not align properly. It affects approximately 4% of children worldwide and can lead to visual impairment if not treated early.

Maternal HDP might impact ocular health in offspring, yet there is no clarity on its association with strabismus. To fill this knowledge gap, Hui Zhu, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China, and colleagues aimed to investigate the association of maternal HDP with overall and type-specific strabismus in offspring.

In the Jiangsu Birth Cohort study conducted in China, pregnant women were enrolled between 2014 and 2018. Out of the initial cohort, which included information on maternal HDP for 6,195 offspring, 3,078 were excluded either due to lack of data on ocular alignment or because they had ocular conditions other than strabismus or refractive error. At the age of 3 years, the remaining children underwent comprehensive ocular examinations completed by May 21, 2022. The data collected were subsequently analyzed from May 28, 2022, to December 15, 2023.

Maternal hypertensive disorders in pregnancy were categorized into groups including hypertension, preeclampsia, or cases where blood pressure (BP) was well controlled (systolic BP <130 mm Hg; diastolic BP <80 mm Hg) versus poorly controlled (systolic BP ≥130 mm Hg; diastolic BP ≥80 mm Hg).

The main focus was on determining the occurrence of strabismus among offspring. Poisson generalized linear mixed models were employed to assess the relationship between maternal HDP and the likelihood of strabismus developing in children.

The following were the key findings of the study:

  • Among the included 3117 children (mean age, 36.30 months; 52.3% boys), 4.6% were exposed to maternal HDP, and 11.8% had strabismus.
  • Offspring exposed to maternal HDP had an 82% increased risk of overall strabismus (relative risk [RR], 1.82), an 82% increased risk of exophoria (RR, 1.82), and a 136% increased risk of intermittent exotropia (RR, 2.36) compared with unexposed offspring.
  • When considering the type of maternal HDP, the risk for all strabismus was high for offspring exposed to preeclampsia (RR, 2.38) compared with unexposed offspring.
  • When considering the BP control level of maternal HDP, the risk for all strabismus was high for offspring born to mothers with HDP and poorly controlled BP (RR, 2.07) compared with unexposed offspring.

“The results indicate a heightened likelihood of strabismus in offspring born to mothers with hypertensive disorders in pregnancy. Early screening for strabismus could be advisable for children whose mothers experienced HDP. Further investigation into the mechanisms linking HDP and strabismus is essential to understand this association,” the researchers concluded.

Reference:

Zhu H, You X, Jing Y, et al. Maternal Hypertensive Disorder in Pregnancy and Childhood Strabismus in Offspring. JAMA Netw Open. 2024;7(7):e2423946. doi:10.1001/jamanetworkopen.2024.23946

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From Diabetes Complications to Mental Health Challenges: Understanding the Two-Way Street

USA: A recent study published in Diabetes Care has revealed a consistent bidirectional association between chronic diabetes complications (CDCs) and mental health disorders (MHDs) across the lifespan.

The findings highlight the important relationship between CDCs and MHDs. Addressing either condition through prevention or treatment measures could potentially lower the risk of developing the other.

“Individuals diagnosed with CDCs faced a significantly elevated risk of developing MHDs. Conversely, those with MHDs had an increased likelihood of developing CDCs, with this association particularly pronounced among younger age groups,” the researchers reported.

Additionally, Type 1 diabetes (T1D) showed a stronger correlation with CDCs in individuals under the age of 60, whereas type 2 diabetes (T2D) exhibited a closer relationship with MHDs.

Brian C. Callaghan, Department of Epidemiology and Biostatistics, Michigan State University, East Lansing, MI, and colleagues conducted the study to determine bidirectional associations between the timing of chronic diabetes complications and mental health disorders in individuals with type 1 or type 2 diabetes.

For this purpose, the researchers used a nationally representative healthcare claims database. They identified matched individuals with T1D or T2D or without diabetes using a propensity score quasi-randomization technique stratified by age (0–19, 20–39, 40–59, and 60+ years). Using ICD-9/10 codes, CDCs and MHDs were identified. Cox proportional hazards models were fit with time-varying diagnoses of CDCs or MHDs to examine their association with the hazard of developing MHDs or CDCs, respectively.

The study revealed the following findings:

  • A total of 553,552 individuals were included (44,735 with type 1 diabetes, 152,187 with type 2 diabetes, and 356,630 without diabetes) from 2001 to 2018.
  • Having a CDC increased the hazard of developing an MHD (hazard ratio [HR] 1.9–2.9, with higher HRs in older age strata), and having an MHD increased the hazard of developing a CDC (HR 1.4–2.5, with the highest HR in age stratum 0–19 years).
  • In those aged <60 years, individuals with type 1 diabetes were more likely to have CDCs, whereas individuals with type 2 diabetes were more likely to have MHDs.
  • The relationship between CDCs and MHDs in either direction was not affected by diabetes type.

“Our research revealed a persistent mutual relationship between chronic diabetes complications and mental health disorders throughout all stages of life, emphasizing their significant interconnection. Addressing either condition through prevention or treatment measures could potentially mitigate the risk of developing the other,” the researchers concluded.

Reference:

Maya Watanabe, Evan L. Reynolds, Mousumi Banerjee, Morten Charles, Kara Mizokami-Stout, Dana Albright, Lynn Ang, Joyce M. Lee, Rodica Pop-Busui, Eva L. Feldman, Brian C. Callaghan; Bidirectional Associations Between Mental Health Disorders and Chronic Diabetic Complications in Individuals With Type 1 or Type 2 Diabetes. Diabetes Care 2024; dc240818. https://doi.org/10.2337/dc24-0818

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Long-acting injectable cabotegravir for HIV prevention safe in pregnancy, suggests study

Long-acting injectable cabotegravir (CAB-LA) was safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in the follow-up phase of a global study among cisgender women. The analysis of outcomes from more than 300 pregnancies and infants will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.

“Cisgender women experience biological changes and social dynamics that can increase their likelihood of acquiring HIV during pregnancy and the postnatal period, and we need to offer them evidence-based options when they may need them most,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “These data provide reassurance about long-acting injectable cabotegravir for HIV prevention during pregnancy.”

CAB-LA is a highly effective HIV prevention method, administered by intramuscular injection every two months. However, data regarding the safety of CAB-LA during pregnancy are limited. An open-label extension study of the CAB-LA efficacy trial in cisgender women included women in several countries across East and Southern Africa who had the potential to become pregnant during the longitudinal study and who did not have HIV. Participants chose between CAB-LA or oral PrEP with tenofovir disoproxil fumarate and emtricitabine and had the option to use contraception if they wished. They were monitored closely for safety. Participants who became pregnant also were monitored for pregnancy-related adverse events including gestational hypertension, pre-eclampsia, and weight gain, as well as infant outcomes, such as miscarriage, intrauterine fetal death or stillbirth, premature birth, or low birthweight.

There were 367 pregnancies in this phase of the study. Pregnancy-related maternal adverse event incidence was 45.7, 47.1, and 37.5 per 100 person years among people using CAB-LA during pregnancy, prior to pregnancy, or with no CAB-LA use, respectively. Adverse infant outcomes were similar across groups, with negative outcomes reported in 33%, 38%, and 27% of pregnancies with CAB-LA use, prior CAB-LA use, or no CAB-LA use, respectively. One major congenital anomaly was reported in a participant receiving CAB-LA. No maternal deaths occurred. Pregnancy and infant outcomes in the study were similar to estimated general population outcomes.

Overall, CAB-LA was safe and well tolerated. These findings demonstrate the safety of using CAB-LA prior to and during pregnancy.

“The overlap between high HIV incidence and the specific risks that cisgender pregnant women face in acquiring HIV in many countries calls for diverse and highly effective PrEP options as part of sexual and reproductive health approaches,” said study chair Sinead Delany-Moretlwe, M.B.B.Ch., Ph.D., director of Research at Wits RHI and professor of Global Health and Infectious Diseases at the University of the Witwatersrand, Johannesburg. “We hope that these findings can fill an important knowledge gap that can help increase access to this highly effective HIV PrEP option among cisgender women before, during, and after pregnancy.”

Reference:

S Delany-Moretlwe et al. Initial evaluation of injectable cabotegravir (CAB-LA) safety during pregnancy in the HPTN 084 open-label extension. International AIDS Conference. Thursday, July 25, 2024.

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Wayanad Landslides: Misssing Odisha doctor’s body recovered, search on for another doctor

Bhubaneswar: After two doctors from Odisha tragically went missing in the devastating landslide in Kerala’s Wayanad district, the police and the rescue team recently found the body of one of the doctors. The confirmation in this regard came from the Revenue and Disaster Management Minister Suresh Pujari.

The two doctors have been identified as Dr. Bishnuprasad Chinra, a resident of Chodwar, and his friend Dr. Swadhin Panda. While the body of Dr Bishnu Prasad has been found, the search is on to trace the other doctor. 

While giving the update, Minister Suresh Pujari said, “It is being suspected to be of Bishnu Prasad Chinara. After proper identification and formalities, arrangements will be made to bring the body to Odisha. While the other doctor is still missing, a team from Odisha is being sent to Kerala.”  

Also read- Odisha doctor goes missing from hospital quarter, Maoist hand suspected

As per Odisha Bytes news report, Dr Bishnu Prasad and his wife, Priyadarshini Pal, a lecturer in a private nursing college, both residents of Choudwar Housing Board colony in Cuttack and another doctor couple Dr. Swadhin Panda, along with his wife, Dr Swikrutee Mohapatra went on a vacation in Wayanad on July 29 when the incident occurred at night. The doctor couples were in Chooralmal, a tourist town surrounded by hills and plantations.   

The group departed from Bengaluru for their trip on July 26 and subsequently travelled to Wayanad in Kerala, where they stayed at Linara Villa. Tragically, landslides occurred in the Meppadi, Mundakkai Town, and Chooral Mala hill regions that same night. After the landslide, mud water flooded various populated areas in the locality. 

Although Priyadharini and Dr Swikrutee were rescued and are currently receiving medical treatment, the search for the missing doctor is ongoing.   

Speaking on this, the Minister said, “The women are under treatment. One among them has been shifted to the general ward after preliminary treatment. We are hopeful that they will recover soon.” 

Also read- Missing patient found dead 2 km from Barmer Medical College

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CDSCO Panel Approves Novo Nordisk’s Protocol Amendment proposal to study Somapacitan

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major Novo Nordisk’s protocol amendment proposal for the study of the human growth hormone analog Somapacitan.

This came after Novo Nordisk presented protocol amendment version 12.0 dated 21 March 2024 protocol no. NN8640-4245. This is a dose-finding trial evaluating the effect and safety of once-weekly treatment of somapacitan compared to daily Norditropin in children with short stature born small for gestational age with no catch-up growth by 2 years of age or older.

Somapacitan is a human growth hormone analog subcutaneous injection indicated for adults with growth hormone deficiency.Somapacitan binds to the growth hormone receptor and induces intracellular signalling to up-regulate insulin-like growth factor I (IGF-1).1,6 IGF-1 causes growth in bones and muscle tissue. Growth hormones more directly cause the fusion of myoblasts and myotubes to cause muscle fibre growth, activate neural stem cells, and induce chondrocyte proliferation.

At the recent SEC meeting for endocrinology and metabolism held on July 11, 2024, the expert panel reviewed the protocol amendment version 12.0 dated 21 March 2024 protocol no. NN8640-4245.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

Also Read: Cipla Gets CDSCO Panel Nod to Study Plazomicin Injection

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Insufficient CT data in female population: CDSCO Panel tells Alkem Laboratories on Relugolix Tablets

New Delhi: Noting insufficient clinical trial data in the female population for applied indication, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Alkem Laboratories to conduct a bioequivalence study of Relugolix Tablets 40 mg as per the protocol presented by the firm.

Furthermore, the expert panel opined that the firm should submit a bioequivalence study report along with clinical trial data on Indian patients or a Phase-III clinical trial protocol to CDSCO for further consideration by the committee.

This came after Alkem Laboratories presented the proposal for the grant of permission to manufacture and market Relugolix 40 mg tablets (Additional Strength) along with the Bioequivalence (BE) study protocol and justification for the waiver of the Phase III clinical trial before the committee.

The firm mentioned that Relugolix 40 mg tablets were approved in Japan in 2019, and the FDC of Relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg was approved in the USA in 2022.

However, the expert panel noted that the firm did not present sufficient clinical trial data in the female population for an applied indication.

Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. This may slow or stop the spread of prostate cancer cells that need testosterone to grow.

Relugolix is indicated for the treatment of adult patients with advanced prostate cancer. In combination with estradiol and norethindrone, relugolix is indicated for the once-daily treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

At the recent SEC meeting for reproductive held on July 4, 2024, the expert panel reviewed the proposal for the grant of permission to manufacture and market Relugolix 40 mg tablets (Additional Strength) along with the BE study protocol and justification for the waiver of the Phase III clinical trial before the committee.

After detailed deliberation, the committee recommended the grant of permission to conduct a Bioequivalence study as per the protocol presented by the firm.

In addition, the expert panel stated to submit a bioequivalence study report along with clinical trial data on Indian patients or a Phase III clinical trial protocol to CDSCO for further consideration by the committee.

Also Read: CDSCO Panel Approves AstraZeneca’s Protocol Amendment Proposal to Study anti-cancer Drug Capivasertib

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