The efficacy of Horizontal- Platelet Rich Fibrin (H-PRF) compared to Alveogyl in the treatment of alveolar osteitis: a randomised controlled trial

Abstract

Objectives: To investigate the efficacy of treating alveolar osteitis with an autologous blood product, Horizontal Platelet Rich Fibrin (H-PRF) compared to Alveogyl, a conventional intra-alveolar dressing.

Materials and Methods: Ethical approval to conduct this prospective, double-blind randomised controlled trial (RCT) was granted by the Joint Research and Ethics Committee (SJH/TUH). Thirty-eight patients presenting with alveolar osteitis following tooth extraction were recruited to participate. A blood sample was obtained immediately pre-operatively (T0) for all participants irrespective of study arm allocation, and H-PRF was prepared following published product protocol. Patients allocated to the treatment arm received H-PRF clot in the extraction socket whereas those allocated to the control arm received Alveogyl. Standardised surgical and analgesia protocols were followed for both study arms. All patients received a virtual review by telephone on day three following intervention (T1) and were asked to return to the clinic for review, seven days following intervention when a second blinded assessor evaluated healing outcomes (T2). Patients kept a diary of their pain levels, analgesia consumption and changes in oral health related quality of life at three timepoints (T0, T1 and T2).

Primary outcome measure was Visual Analogue Scale (VAS) pain score data. Secondary outcome measures included analgesia use, socket healing and health related quality of life parameters (HRQoL) in the early postoperative period. Statistical analysis was performed using IBM SPSS �29.0 software.. Categorical variables were analysed using the Chi square test. The non-parametric Mann Whitney U test was used to analyse VAS pain scores and healing measurements. Median, interquartile range, effect size and p-values for appropriate tests of comparison between treatment groups were reported for HRQoL parameters.

Results: The mean age of participants was 39.5 (21-78 range, 12.9 SD) with females accounting for 51.4% of the study sample. VAS scores were significantly lower for worst pain score at T1 (Z=2.49, (p= 0.011) and T2 (Z=2.76, p=0.006) in the H-PRF group following intervention in the absence of significant difference in pain scores between groups at baseline (T0, p=0.294). Significantly more Paracetamol was consumed by patients in the Alveogyl group at T1 (Z= 2.81, p=0.007) and T2 (Z=2.47, p=0.026). Socket healing, graded using a modified Landry healing index demonstrated clinically significant improved healing in patients treated with H-PRF at T2 (Z= 3.04, p=0.003). No significant differences were observed in the HRQoL subscales between groups overall, with the exception of �sleep� being reported as improved at T1 in the H-PRF group (Z=0.71, p=0.029).

Conclusion: The study concludes that there is a significant difference in the early alleviation of pain and improved healing outcomes where patients with alveolar osteitis are treated with H-PRF as opposed to Alveogyl. The difference in oral health related quality of life parameters was not significant for either group. This study has implications for clinicians deciding on how best to manage their patients with alveolar osteitis and suggests that the use of H-PRF is safe and could be considered as an alternative to current standard(s) of care in the management of alveolar osteitis.