Background: A novel dehydrated Human Amniotic Membrane (dHAM) allograft is a placental based scaffold that has been widely used in a verity of medical fields due to its unique regenerative ability in wound healing. Objective: To evaluate clinically, radiographically, and histopathologically the efficacy of dehydrated Human Amniotic Membrane allograf as a pulpotomy agent in primary teeth. Materials and Methods: I- Clinical and radiographical evaluation: This split-mouth, randomized clinical trial was conducted on 40 deeply carious primary molars indicated for pulpotomy. They were selected from 16 healthy children aged 4-8 years. They were randomly allocated into two equal groups (20 molars/each). Group 1: dHAM pulpotomy in one quadrant and Group 2: Formocresol (FC) pulpotomy in the contralateral. All molars were treated with the conventional pulpotomy technique. All patients were recalled for clinical and radiographical evaluation at 3, 6, and 9 months post-treatment. II- Histopathological assessment: A total of 30 healthy lower first primary molars and canines that indicated for serial extraction were selected for histopathological evaluation. The dHAM allograft and formocresol pulpotomies were performed (12 teeth/each group), where the other 6 teeth were used as a control. Six teeth from each experimental group were extracted at post-treatment intervals; one and three months. The samples were prepared for histopathological evaluation. All data were subjected to the exact test. Fisher exact test and Monte Carlo test were also used. The level of significance was set at P<0.05.
Results: I-Clinical and radiographic results: The overall clinical success rates for both groups were 100%, whereas the overall radiographic success rates for dHAM and FC groups were 100% and 85%, respectively, but the difference was not statistically significant (p>0.05). II-Histopathological results: The overall evaluation at 1-month interval showed better histopathological criteria for dHAM group than FC group, but the difference was only significantly better on the degree of the inflammatory response (p<0.05). Whereas at 3-month interval, the dHAM group displayed significantly better histopathological criteria compared to the FC group (p<0.05). Conclusion: The dHAM allograft with its regenerative, biologic biocompatibility properties and its ability to deliver growth factors has shown successful outcome comparable to gold standard formocresol. Hence, it can be recommended as an alternative promising pulpotomy agent.