インプラント周囲炎に対する再建外科治療：多施設共同無作為化比較臨床試験

Reconstructive surgical therapy of peri-implantitis: a multicenter randomized controlled clinical trial.

抄録

目的:

インプラント周囲炎の再建外科治療において、骨補填材を使用することの潜在的有用性を評価すること。

OBJECTIVE: To evaluate the potential benefit of the use of a bone substitute material in the reconstructive surgical therapy of peri-implantitis.

方法:

METHODS: In this multicenter randomized clinical trial, 138 patients (147 implants) with peri-implantitis were treated surgically, randomized by coin toss to either a control (access flap surgery) or a test group (reconstructive surgery using bone substitute material). Clinical assessments, including probing pocket depth (PPD), bleeding and suppuration on probing (BOP & SOP) as well as soft tissue recession (REC), were recorded at baseline, 6 months and 12 months. Marginal bone levels (MBL), measured on intra-oral radiographs, and patient-reported outcomes (PROs) were recorded at baseline and 12 months. No blinding to group allocation was performed. The primary outcome at 12 months was a composite measure including (i) implant not lost, (ii) absence of BOP/SOP at all aspects, (iii) PPD ≤5 mm at all aspects and (iv) ≤1 mm recession of mucosal margin on the buccal aspect of the implant. Secondary outcomes included (i) changes of MBL, (ii) changes of PPD, BOP%, buccal KM, (iii) buccal REC and (iv) patient-reported outcomes.

結果:

追跡期間中、4人の患者の4本のインプラント（テスト群1本、コントロール群3本）が病気の進行のために除去された。12ヶ月後、テスト群69本、コントロール群68本のインプラントが検査された。したがって、テスト群では16.4%、コントロール群では13.5%のインプラントが、事前に定義された複合結果の基準をすべて満たしたことになる。PPDの減少およびMBLの増加は、両群とも3.7mmおよび約1.0mmであった。平均BOP%は45%（test群）と50%（control群）の間で変化したが，群間で有意差は認められなかった．Buccal RECはコントロール群（M=1.1，SD=1.5mm）に比べテスト群（M=0.7，SD=0.9mm）でより顕著でなかった。PROは両群とも有意差なく良好であった。抗生物質治療に対するアレルギー反応が1例記録された。その他の有害事象は認められなかった。

RESULTS: During follow-up, 4 implants (1 in the test group, 3 in the control group) in 4 patients were removed due to disease progression. At 12 months, a total of 69 implants in the test and 68 implants in the control group were examined. Thus, 16.4% and 13.5% of implants in the test and control group, respectively, met all pre-defined criteria of the composite outcome. PPD reduction and MBL gain were 3.7 mm and about 1.0 mm in both groups. Reduction of mean BOP% varied between 45% (test) and 50% (control), without significant differences between groups. Buccal REC was less pronounced in the test group (M=0.7, SD=0.9 mm) when compared to controls (M=1.1, SD=1.5 mm). PROs were favorable in both groups without significant differences. One case of allergic reaction to the antibiotic therapy was recorded. No other adverse events were noted.

結論:

インプラント周囲炎に対する外科的治療は、12ヶ月後の臨床的およびX線写真の状態を効果的に改善した。骨補填材の使用はPPDとBOPの減少を改善しなかったが，テスト群では頬側RECはより顕著であった．両群とも患者満足度は高かった．

CONCLUSIONS: Surgical therapy of peri-implantitis effectively improved the clinical and radiographic status at 12 months. While the use of a bone substitute material did not improve reductions of PPD and BOP, buccal REC was less pronounced in the test group. Patient satisfaction was high in both groups.