Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrosealing Materials

Objectives: Evaluate the extent of healing following the use of 3 different retrosealant materials in patients who underwent apical microsurgery
Methods: 74 patients from Endodontics Department, University of Valparaiso, Chile, were selected; 15 were eliminated due to fracture, fissures or drop outs. Surgical procedure was performed by one trained endodontist assisted by residents/assistants. For each surgery, one material (EndoSequence®, ProRoot® MTA, or Biodentine™) was blindly and randomly selected. Patients returned at 2, 4 and 6 months for clinical/CBCT assessments. The 59 eligible patients completed follow-up of 6 months (n=37), 4 months (n=8), 2 months (n=14). Data of material chosen were blinded until results/statistical analysis were completed. Size of the periapical radiolucent area associated with each tooth treated was measured preoperatively, postoperatively, and at each follow-up using a 4 level classification.
Results: Healing progression ranged from none-to-minimal in 5 patients to complete remineralization (7 patients). In 5 patients, there was a relatively large radiolucent area greater than 5mm which persisted even 6 months postoperatively suggesting longer healing (or no healing) process or possibly cicatrization; however, this was not dependent on the material used. On the subjective evaluation, 19 patients of 34 who completed full 6 months follow-up, showed complete remineralization. Only 2 subjects showed no remineralization (possible fibrous healing). Statistical analysis included testing of the reliability of measurements, assessed by intra-class correlation coefficients (Cronbach’s alpha values). Non-parametric tests were used to examine differences in outcomes amongst the 3 treatment groups. Kruskal-Wallis test was used to examine differences amongst the 3 groups and pair-wise comparisons were conducted by using Mann-Whitney tests. Subjective evaluation was not dependent on the material used and was not statistically significant.
Conclusions: There was no statistically significant difference in the progress of healing, irrespective of the material used.