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Clinical trials in dentistry in India: Analysis from trial registry

View Article: PubMed Central - PubMed

ABSTRACT

Introduction:: Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years.

Methodology:: All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword “dental.” Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time.

Results:: The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy participants. From 2011, some of the postgraduate thesis trials had also been registered (2011-8; 2012-8; 2013-13; 2014-6). Inadequacy in reporting the method of randomization and allocation concealment was observed in 37/67 (55.2%) and 31/67 (46.2%) clinical trials respectively. A considerable number of postgraduate theses was also registered with CTRI in dentistry and majority of the clinical trials despite being completed are not yet published.

Conclusion:: The number of clinical trials in dentistry are low in India, and more focus should be placed by dental investigators regarding the reporting standards. Furthermore, researchers and trial sponsors should aim at publication of the research findings so that it is made publically available for use. A clear-cut need exists for an increase in both the quantity and quality of clinical trials in dentistry.

No MeSH data available.


Trend analysis of registered clinical trials in dentistry between 2007 and March 2014
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Figure 1: Trend analysis of registered clinical trials in dentistry between 2007 and March 2014

Mentions: The search yielded a total of 133 clinical trials, of which 84 trials (3-2007; 4-2008; 4-2009; 6-2010; 22-2011; 16-2012; 21-2013 and 8 in 2014 till 3rd March) have been found to belong to the field of dentistry. Of these, in the years 2007, 2013, and 2014, all the registered clinical trials were single centered. In general, majority of the clinical trials were single centered (only two each in the year 2010, 2011 and one each in 2008, 2009, and 2012 were multicentric). The trend analysis of total registered clinical trials as well as, whether it was a single or multicentered is depicted in Figure 1.


Clinical trials in dentistry in India: Analysis from trial registry
Trend analysis of registered clinical trials in dentistry between 2007 and March 2014
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5384407&req=5

Figure 1: Trend analysis of registered clinical trials in dentistry between 2007 and March 2014
Mentions: The search yielded a total of 133 clinical trials, of which 84 trials (3-2007; 4-2008; 4-2009; 6-2010; 22-2011; 16-2012; 21-2013 and 8 in 2014 till 3rd March) have been found to belong to the field of dentistry. Of these, in the years 2007, 2013, and 2014, all the registered clinical trials were single centered. In general, majority of the clinical trials were single centered (only two each in the year 2010, 2011 and one each in 2008, 2009, and 2012 were multicentric). The trend analysis of total registered clinical trials as well as, whether it was a single or multicentered is depicted in Figure 1.

View Article: PubMed Central - PubMed

ABSTRACT

Introduction:: Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years.

Methodology:: All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword “dental.” Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time.

Results:: The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy participants. From 2011, some of the postgraduate thesis trials had also been registered (2011-8; 2012-8; 2013-13; 2014-6). Inadequacy in reporting the method of randomization and allocation concealment was observed in 37/67 (55.2%) and 31/67 (46.2%) clinical trials respectively. A considerable number of postgraduate theses was also registered with CTRI in dentistry and majority of the clinical trials despite being completed are not yet published.

Conclusion:: The number of clinical trials in dentistry are low in India, and more focus should be placed by dental investigators regarding the reporting standards. Furthermore, researchers and trial sponsors should aim at publication of the research findings so that it is made publically available for use. A clear-cut need exists for an increase in both the quantity and quality of clinical trials in dentistry.

No MeSH data available.