Comparing 2 Different Scaffolds in Regenerative Endodontics of Mature Teeth with Apical Periodontitis: A Randomised Clinical Trial.

AIM: This randomised clinical study assessed and compared the healing outcomes, both clinical and radiographic, of platelet-rich fibrin (PRF) and human amniotic membrane (HAM) scaffolds in regenerative endodontic therapy for necrotic mature permanent teeth with apical periodontitis.

METHODOLOGY: The study protocol was registered on the Clinical Trial Registry (CTRI/2023/12/060979). Thirty participants presenting with necrotic mature permanent teeth and apical lesions were assigned to either the PRF or HAM group (n=15 each) randomly. Follow-up evaluations were performed at baseline, 6 months, and 12 months, with clinical assessments and periapical radiographs conducted at all 3 time points, while cone-beam computed tomography (CBCT) imaging was obtained at baseline and at 12 months. Standardised regenerative endodontic procedures were performed by a single operator. Examiner calibration was completed prior to data collection to ensure consistency in measurements.

RESULTS

At the 12-month follow-up, both groups demonstrated favourable clinical outcomes, with resolution of symptoms and radiographic evidence of periapical healing. The CBCT analysis revealed significant reductions in lesion volume for both PRF (65.26%) and HAM (64.75%) groups (P < .005), without a statistically significant difference between the groups. Periapical healing scores improved similarly in both groups. Sensibility tests revealed no return of pulp responsiveness in any case throughout the study period.

CONCLUSION

Both PRF and HAM scaffolds supported periapical healing in necrotic mature permanent teeth. However, biological regeneration of the functional pulp-dentin complex could not be confirmed, indicating that periapical healing occurred without verified neurovascular re-establishment. The restricted sample size and limited follow-up duration suggest the need for further studies with larger populations and extended observation periods to substantiate these findings.