Polynucleotide-Hyaluronic Acid Gel as an Adjunct to Tooth Extraction in Patients at Risk of MRONJ: A Randomized Split-Mouth Clinical Trial.

Abstract

Objective: To evaluate whether adjunctive intrasocket application of a polynucleotide-hyaluronic acid gel improves early post-extraction soft-tissue healing and postoperative pain in patients exposed to medications associated with medication-related osteonecrosis of the jaw.

Materials and methods: In this single-center randomized split-mouth clinical study, adults requiring bilateral simple tooth extractions in the same arch and opposite hemi-arches underwent 2 procedures in separate sessions spaced 4 weeks apart. After extraction and socket debridement, the test site received 5 mL of polynucleotide-hyaluronic acid gel (Regenfast®) before primary closure, whereas the control site received standard management without adjunctive biomaterial. Wound healing was assessed using the inflammatory proliferative remodeling (IPR) wound-healing scale. The primary outcome was the total IPR score at 6 weeks. Secondary outcomes were IPR subscale scores at 3 to 5 days, 14 days, and 6 weeks, and postoperative pain measured with the Numerical Rating Scale (NRS). Paired comparisons were performed with appropriate within-patient tests.

Results: Thirty-two patients (13 men, 19 women) completed follow-up without adverse events. No significant differences were found between test and control sites at 3 to 5 days (P=0.521), at 6 weeks (P=0.841), or for total IPR score at 6 weeks (P=0.318). A statistically significant difference favoring the test sites was observed at 14 days (P<0.05). Postoperative pain did not differ between sites (P=0.873).

Conclusions: Adjunctive polynucleotide-hyaluronic acid gel was associated with a phase-specific improvement in soft-tissue healing at 14 days, without significant differences in overall 6-week healing or pain.