Abstract:
Dental caries is a multifactorial chronic infectious disease characterized by demineralization of
inorganic matter with destruction of organic content in tooth caused by acidic bacterial by-products and
subsequent inflammation. Presence of microorganisms with prevailing inflammation can be controlled by
restorative materials like glass ionomer cement (GIC) via its inherent ability to release fluoride having
antibacterial and indirect anti-inflammatory effects. Various antibiotics have been incorporated to improve
the efficacy of GIC. In present study metformin, a first line anti-diabetic agent exhibiting antibacterial,
anti-inflammatory and re-mineralization potential simultaneously was incorporated in GIC, to treat all
three aspects of dental caries, infection, inflammation and demineralization effectively and named as
metformin containing glass ionomer cement (MGIC). The objectives of the present study were to evaluate
and compare the effects of GIC and MGIC on clinical, radiological, microbiological and periodontal
parameters in class II extensive caries in premolars or molars of systemically healthy adult patients and to
assess and compare any adverse effects and cost-effectiveness amongst the two groups. In this single blind,
randomized clinical trial, after FRC and ERC approval, 45 systemically healthy males and females, aged
19-35 years with extensive class II carious lesion in premolars or molars presenting in Operative Dentistry
Department of Bahria Dental Hospital were included. After written informed consent they were
randomized by computer driven list to receive GIC (Group A, n=22) or MGIC (Group B, n=23). At
baseline, day 45 and 90, Clinical parameters: PI, GI, PPD, sensibility test, percussion test were evaluated.
Dentin condition, Microbiological parameter (CFU count of streptococcus mutans), Radiological
parameters (RDT, periapical and furcation area involvement) were evaluated at baseline and day 90.
Adverse effects and Cost effectiveness were also evaluated. A total of 41 patients completed the study.
(Group A=20, Group B=21). In group A, only PI and GI while in group B, GI, PD and CFU count showed
statistically significant improvement from day 0 to 90. Intergroup comparison showed significant mean
difference in gingival index and CFU (p-value <0.001). Mean difference in PD and RDT although non significant showed better results in group B. PI improved in more number of patients in group A, whereas
GI, PD, RDT and CFU improved in more number of group B patients with statistically significant results
in GI, PD RDT and CFU. Dentin condition improved in 17 patients in group B and 11 in group A. Results
of simple linear regression showed group B to be superior than group A. Tooth vitality was maintained by
all study participants in both groups (assessed by cold test and EPT). Similarly, none of the participants
exhibited periapical changes (assessed by pain on percussion, periapical area and furcation area
x
involvement). No adverse effects were reported by any of the participants nor did they require refilling.
Both GIC and MGIC showed cost effectiveness. Group B (MGIC) produced better clinical, radiological,
microbiological and periodontal outcomes compared to Group A (GIC). Patients in both groups had no
adverse effects and found the treatments cost effective. Hence, MGIC was found to be superior to GIC
