Short-term patient-reported outcomes correlate with clinical parameters in guided bone regeneration.

Abstract

Design: The prospective observational study aimed to record the short-term patient-reported outcomes (PROMs) like pain, swelling, difficulty in mouth opening, and oral health quality of life (oral health impact profile-14), following a single-site tooth extraction and guided bone regeneration(GBR) using resorbable membrane and bone allograft. Correlation of PROMs with clinical/intra-surgical parameters like flap advancement, gingival and mucosal thickness, surgery duration, and wound opening were observed. PROMs and clinical parameters were assessed pre-operatively and on days 2,4,7 and 14 during the postoperative two weeks.

Cohort selection: Systemically healthy, non-smoker twenty-seven patients fulfilling the inclusion criteria of the dentate site with immediate post-extraction buccal dehiscence ≥4 mm were recruited. Only one tooth site from each patient was included in the study.

Data analysis: The severity of pain, swelling, and difficulty in mouth opening were reported as zero, mild (1-3), moderate(4-6), and severe(7-10) using visual analog scores(VAS). The number of patients experiencing symptoms was presented as a percentage. Mean, standard error, median values, and IQR are reported for all OHIP-14 domains at various time points. Spearmen's coefficient was used to correlate four PROMs for overall values for each time point separately and to correlate with clinical parameters. P < 0.05 was considered statistically significant.

Results: VAS for all PROMs peaked on post-surgical day 2 and improved until day 14. Most patients experienced no or mild symptoms during postoperative two weeks, with moderate to severe responses reported by 41-56% of patients on day 2. All PROMs correlated significantly with each other, with a strong correlation between VAS for pain and swelling. In the context of post-surgical oral health quality of life (OHIP-14), patients reported physical pain as the most experienced outcome, followed by psychological discomfort at all time points. All three PROMs pain, swelling, and difficulty of mouth opening positively correlated with all domains of OHIP-14, with the strongest correlation between the physical pain domain with VAS pain(day 7) and VAS swelling(day 2). Measured gingival thickness, mucosal thickness, flap advancement, and duration of surgery were 0.42 ± 0.04 mm, 0.2 ± 0.02 mm,6.8 ± 0.5 mm, and 123 ± 6 min, respectively. All clinical parameters and pre-operative PROMs correlated with post-operative PROMs. Wound opening was maximum on day 7 with an average extent of 3.3 mm and prevalence in 81.5%patients. Wound opening and duration of surgery were highly correlated with pain and flap advancement with difficulty of mouth opening on 7 th day. OHIP-14 was strongly associated with gingival thickness and wound healing on days 2 and 7, respectively.

Conclusion: Short-term postoperative patient-reported outcomes are most severe on the second-day post-GBR. Clinical parameters like soft tissue thickness, flap advancement, and wound opening duration of surgery impact the PROMs like pain, swelling, and difficulty in mouth opening and thus influence the postoperative quality of life.