Clinic of Dental and Oral Pathology, Lithuanian University of Health Sciences, Eiveniu 2, 50103, Kaunas, Lithuania.
Department of Periodontology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Clin Oral Investig. 2023 Nov;27(11):6645-6656. doi: 10.1007/s00784-023-05271-0. Epub 2023 Sep 23.
To compare the clinical outcomes obtained with either mechanical subgingival debridement in conjunction with a sodium hypochlorite and amino acids containing gel followed by subsequent application of a cross-linked hyaluronic acid gel (xHyA) gel, or with mechanical debridement alone.
Fourty-eight patients diagnosed with stages II-III (Grades A/B) generalised periodontitis were randomly treated with either scaling and root planing (SRP) (control) or SRP plus adjunctive sodium hypochlorite/amino acid and xHyA gels (test). The primary outcome variable was reduction of probing depth (PD), while changes in clinical attachment level (CAL), bleeding on probing (BOP) and plaque index (PI) were secondary outcomes. The outcomes were assessed at baseline, at 3 and 6 months following therapy.
All patients completed the 6 months evaluation. At 6 months, the test group showed statistically significantly better results in terms of mean PD reduction (2.9 ± 0.4 vs 1.8 ± 0.6 mm, p < 0.001). Similarly, mean CAL gain was statistically higher in the test group compared to the control one (test: 2.6 ± 0.5 vs control: 1.6 ± 0.6 mm, p < 0.001). Mean BOP decreased from 81.8 ± 16.2% to 48.9 ± 14.5% in control (p < 0.001) and from 83.2 ± 15.5% to 17.6 ± 11.5% in test (p < 0.001) groups with a statistically significant difference favouring the test group (p < 0.001). Mean PI scores were reduced statistically significantly in both groups (from 38.8 ± 26% to 26.5 ± 20.5% in control (p = 0.039) and from 60.6 ± 10.9% to 12.7 ± 8.9% in test group (p < 0.001)), with a statistically significant difference between the groups (p < 0.001). The number of moderate pockets (4-6 mm) were reduced from 1518 (41.2%) to 803 (22.6%) in the control and from 1803 (48.6%) to 234 (7.7%) in the test group with a statistically significant difference between the groups (p < 0.001), while the number of deep pockets (≥ 7 mm) changed from 277 (7.6%) to 35 (1.0%) in the control and from 298 (8.7%) to 4 (0.1%) in test group (p = 0.003).
Within their limits the present data indicate that: a) both treatments resulted in statistically significant improvements in all evaluated clinical parameters, and b) the adjunctive subgingival application of sodium hypochlorite/amino acid and xHyA to SRP yielded statistically significantly higher improvements compared to SRP alone.
The combination of sodium hypochlorite/amino acid and xHyA gels to subgingival mechanical debridement appears to represent a valuable approach to additionally improve the outcomes of non-surgical periodontal treatment. Clinical Trial Registration Number NCT04662216 (ClinicalTrials.gov).
比较机械性龈下刮治联合次氯酸钠和氨基酸凝胶，随后应用交联透明质酸钠凝胶（xHyA）凝胶与单纯机械性龈下刮治在临床效果上的差异。
48 例诊断为 II-III 级（A/B 级）广泛性牙周炎的患者被随机分为两组，分别接受龈下刮治（对照组）或龈下刮治联合次氯酸钠/氨基酸凝胶和 xHyA 凝胶（实验组）治疗。主要结局变量是探诊深度（PD）的减少，而临床附着水平（CAL）、探诊出血（BOP）和菌斑指数（PI）的变化为次要结局。在治疗前、治疗后 3 个月和 6 个月评估这些结果。
所有患者均完成了 6 个月的评估。在 6 个月时，实验组在 PD 平均减少方面表现出统计学上的显著更好的结果（2.9 ± 0.4 毫米对 1.8 ± 0.6 毫米，p < 0.001）。同样，实验组与对照组相比，CAL 平均增加量更高（实验组：2.6 ± 0.5 毫米对对照组：1.6 ± 0.6 毫米，p < 0.001）。BOP 从 81.8 ± 16.2%下降到 48.9 ± 14.5%（对照组，p < 0.001）和 83.2 ± 15.5%下降到 17.6 ± 11.5%（实验组，p < 0.001），实验组具有统计学上的显著差异（p < 0.001）。两组的 PI 评分均显著下降（对照组从 38.8 ± 26%下降到 26.5 ± 20.5%，p = 0.039；实验组从 60.6 ± 10.9%下降到 12.7 ± 8.9%，p < 0.001），两组之间存在统计学差异（p < 0.001）。中度袋（4-6 毫米）的数量从 1518 个（41.2%）减少到对照组的 803 个（22.6%）和实验组的 1803 个（48.6%）减少到 234 个（7.7%），两组之间存在统计学差异（p < 0.001），而深度袋（≥7 毫米）的数量从 277 个（7.6%）减少到对照组的 35 个（1.0%）和实验组的 298 个（8.7%）减少到 4 个（0.1%），差异有统计学意义（p = 0.003）。
在其限制范围内，目前的数据表明：a）两种治疗方法均在所有评估的临床参数中取得了统计学上的显著改善；b）次氯酸钠/氨基酸凝胶与龈下机械清创术联合应用可显著提高非手术牙周治疗的效果。
次氯酸钠/氨基酸和 xHyA 凝胶联合机械性龈下刮治似乎是一种有价值的方法，可以进一步提高非手术牙周治疗的效果。临床试验注册号 NCT04662216（ClinicalTrials.gov）。
