Effect of a Maintenance Protocol After Surgical Treatment of Peri-implantitis
2022年10月5日 更新者：Universidad Complutense de Madrid
Effect of a Maintenance Protocol Based on the Surgical Treatment of Peri-implantitis and Implant Surface Decontamination With Glycine Powder Air-polishing
This study was designed as a 12-month, two arms, randomized clinical trial to evaluate the efficacy of a supportive treatment protocol (SPIT).
Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups.
After ultrasonic debridement, the affected implant surfaces of the test group were treated with glycine powder air-polishing, while implants in the control group a rubber cup and polishing paste was used.
Maintenance visits were carried every 3 months and clinical, radiological, microbiological and biochemical variables were registered at baseline (6 months after surgery) and after a follow-up period of 12 months (18 months after surgery).
調査の概要
詳細な説明
Study design:
This study was designed as a 12-month, two arms, RCT to evaluate the efficacy of a SPIC protocol. Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups. After ultrasonic debridement, the affected implant surfaces of the test group were treated with glycine powder air-polishing, while implants in the control group a rubber cup and polishing paste was used. Maintenance visits were carried every 3 months and clinical, radiological, microbiological and biochemical variables were registered at baseline (6 months after surgery) and after a follow-up period of 12 months (18 months after surgery).
Interventions:
At the 6-month evaluation after the surgery, the baseline data for the present study were obtained and patients were randomised using a computerized block randomization protocol to one of the following SPIC protocols. In the test group, implant surfaces were treated with glycine powder air-polishing after ultrasonic instrumentation; the specific nozzle was activated subgingivally and circumferentially around the implant for 1 minute. In the control group, implants were cleaned with a rubber cup and polishing paste after ultrasonic instrumentation. This SPIC visits were carried out at 6 (baseline visit), 9, 12, 15 and 18 months after surgery.
研究の種類
介入
入学 (実際)
30
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Presence of at least one implant with peri-implantitis, defined as: radiographic evidence of bone loss >2 mm, inflammation of the peri-implant mucosa as defined by positive BoP and/or suppuration, and at least one site with PD ≥ 5 mm.
- Based on the radiographic examination, the affected implant should not have a vertical peri-implant defect. Positive selection was based on the presence of pe-ri-implant lesions wider than 4 mm, with an angle greater than 35 º.
- In patients with a history of periodontitis, periodontal therapy should have been provided at least 6 months prior to the initiation of the study.
Exclusion Criteria:
- Presence of relevant medical conditions and/or systemic medications that would contraindicate the surgical procedure or modify the tissue response after therapy.
- Patients requiring antibiotic prophylaxis.
- Heavy smokers (> 10 cigarettes/day).
- Pregnant or lactating women
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Glycine - Test
Polishing treatment with glycine powder air-polishing after ultrasonic plaque debridement.
|
Every 3 months, ultrasonic instrumentation was carried out with an specific implant tip coated with Polyether Ether Ketone (PEEK), activated subgingivally and circumferentially around the implant.
Then, the implants were treated with glycine powder air-polishing.
|
|
アクティブコンパレータ：Rubber cup - Control
Polishing treatment with a rubber cup and polishing paste after ultrasonic debridement
|
Every 3 months, ultrasonic instrumentation was carried out with an specific implant tip coated with Polyether Ether Ketone (PEEK), activated subgingivally and circumferentially around the implant.
Then, the implants were treated with rubber cup and a polishing paste.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Probing Pocket Depth
時間枠：Baseline, 6 and 18 months after the surgical procedure
|
Changes in Probing Pocket Depth measured in milimeters with a manual periodontal probe
|
Baseline, 6 and 18 months after the surgical procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Distance of Gingival Recession
時間枠：Baseline, 6 and 18 months after the surgical procedure
|
Recession distance of the mucosal margin relative to the restoration margin (REC) at the implant (6 sites/implant) measured in milimeters with a manual periodontal probe
|
Baseline, 6 and 18 months after the surgical procedure
|
|
Bleeding on Probing index
時間枠：Baseline, 6 and 18 months after the surgical procedure
|
Rate of Presence / absence Bleeding on Probing at the implant (6 sites/implant)
|
Baseline, 6 and 18 months after the surgical procedure
|
|
Plaque Index
時間枠：Baseline, 6 and 18 months after the surgical procedure
|
Rate of Presence / absence of Plaque at the implant (6 sites/implant)
|
Baseline, 6 and 18 months after the surgical procedure
|
|
Suppuration Index
時間枠：Baseline, 6 and 18 months after the surgical procedure
|
Rate of Presence / absence of suppuration at the implant (6 sites/implant)
|
Baseline, 6 and 18 months after the surgical procedure
|
|
Radiographic bone loss distance measured from the prosthetic connection platform to the bottom of the intraosseous defect
時間枠：Baseline, 6 and 18 months after the surgical procedure
|
Intraoral standardised radiographs of the site of interest measured in digital intraoral radiographs using an image-processing software
|
Baseline, 6 and 18 months after the surgical procedure
|
|
Concentration of the selected cytokines measured in pg/ml (IL1B; Il-6; IL-8; Tumoral Necrosis Factor Alpha)
時間枠：Baseline, 6 and 18 months after the surgical procedure
|
Samples taken from the gingival crevicular fluid (GCF) were taken from each included implant from the deepest PD site with positive BoP, at baseline and at the final evaluation, always prior to microbiological sampling.
Samples were taken using the filter paper technique.
After isolation of the area with cotton rolls and gentle cleaning with air and a gauze to remove supragingival biofilm deposits and potential saliva contamination, a paper strip of standard length and height was inserted into the peri-implant pocket, until mild resistance was felt and left in place for 30 seconds.
The soaked volume of GCF was measured using the Periotron 8000® device.
Subsequently, the paper strips were inserted in micro-centrifuge plastic tubes and immediately stored at -80°C until further processing.
Analyses were carried out using a Luminex System (Luminex® 200, Luminex Corporation, Austin, TX, USA) to determine volume of the following biomarkers: IL-1β, IL-6, IL-8 and TNF-α.
|
Baseline, 6 and 18 months after the surgical procedure
|
|
Presence of putative periodontal pathogens
時間枠：Baseline, 6 and 18 months after the surgical procedure
|
Sample from the deepest site in the evaluated implant using two consecutive sterile paper-points kept in place for 10 seconds and then transferred into a screw-capped vial, containing 1.5 mL of reduced transport fluid (RTF).
Samples were transferred to the microbiological laboratory within 2 hours and homogenized by vortexing for 30 seconds and serially diluted in phosphate buffer saline (PBS).
Then, 0.1 mL of each dilution was plated manually on the specific medium Dentaid-1, for the detection of Aggregatibacter actinomycetemcomitans, and incubated for 3 days in air with 5% CO2 at 37ºC.
Samples were also plated into a non-selective blood agar plate, supplemented with haemine (5 mg/l), menadione (1 mg/l) and 5% sterile horse blood, with 7-14 days of anaerobic incubation.
|
Baseline, 6 and 18 months after the surgical procedure
|
|
Frequency of detection of putative periodontal pathogens
時間枠：Baseline, 6 and 18 months after the surgical procedure
|
Sample from the deepest site in the evaluated implant using two consecutive sterile paper-points kept in place for 10 seconds and then transferred into a screw-capped vial, containing 1.5 mL of reduced transport fluid (RTF).
Samples were transferred to the microbiological laboratory within 2 hours and homogenized by vortexing for 30 seconds and serially diluted in phosphate buffer saline (PBS).
Then, 0.1 mL of each dilution was plated manually on the specific medium Dentaid-1, for the detection of Aggregatibacter actinomycetemcomitans, and incubated for 3 days in air with 5% CO2 at 37ºC.
Samples were also plated into a non-selective blood agar plate, supplemented with haemine (5 mg/l), menadione (1 mg/l) and 5% sterile horse blood, with 7-14 days of anaerobic incubation.
|
Baseline, 6 and 18 months after the surgical procedure
|
|
Proportions of putative periodontal pathogens
時間枠：Baseline, 6 and 18 months after the surgical procedure
|
Sample from the deepest site in the evaluated implant using two consecutive sterile paper-points kept in place for 10 seconds and then transferred into a screw-capped vial, containing 1.5 mL of reduced transport fluid (RTF).
Samples were transferred to the microbiological laboratory within 2 hours and homogenized by vortexing for 30 seconds and serially diluted in phosphate buffer saline (PBS).
Then, 0.1 mL of each dilution was plated manually on the specific medium Dentaid-1, for the detection of Aggregatibacter actinomycetemcomitans, and incubated for 3 days in air with 5% CO2 at 37ºC.
Samples were also plated into a non-selective blood agar plate, supplemented with haemine (5 mg/l), menadione (1 mg/l) and 5% sterile horse blood, with 7-14 days of anaerobic incubation.
|
Baseline, 6 and 18 months after the surgical procedure
|
|
Counts of putative periodontal pathogens
時間枠：Baseline, 6 and 18 months after the surgical procedure
|
Sample from the deepest site in the evaluated implant using two consecutive sterile paper-points kept in place for 10 seconds and then transferred into a screw-capped vial, containing 1.5 mL of reduced transport fluid (RTF).
Samples were transferred to the microbiological laboratory within 2 hours and homogenized by vortexing for 30 seconds and serially diluted in phosphate buffer saline (PBS).
Then, 0.1 mL of each dilution was plated manually on the specific medium Dentaid-1, for the detection of Aggregatibacter actinomycetemcomitans, and incubated for 3 days in air with 5% CO2 at 37ºC.
Samples were also plated into a non-selective blood agar plate, supplemented with haemine (5 mg/l), menadione (1 mg/l) and 5% sterile horse blood, with 7-14 days of anaerobic incubation.
|
Baseline, 6 and 18 months after the surgical procedure
|
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ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2013年1月1日
一次修了 (実際)
2021年8月1日
研究の完了 (実際)
2021年8月1日
試験登録日
最初に提出
2022年9月26日
QC基準を満たした最初の提出物
2022年10月5日
最初の投稿 (実際)
2022年10月10日
学習記録の更新
投稿された最後の更新 (実際)
2022年10月10日
QC基準を満たした最後の更新が送信されました
2022年10月5日
最終確認日
2022年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。