Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis (aPDT-NSPT)
Efficacy of Antimicrobial Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study
Gum disease (periodontitis) affects millions of people worldwide and can lead to tooth loss if untreated. The standard treatment is a deep cleaning procedure called non-surgical periodontal therapy (NSPT), where a dentist removes bacterial buildup from beneath the gums. Sometimes, harmful bacteria remain after this cleaning and the disease can return.
This study tests whether adding a light-based antibacterial treatment - called photodynamic therapy (PDT) - to the standard deep cleaning improves results. PDT works by placing a harmless green dye (indocyanine green) into the gum pocket, then shining a specific laser light on it. The light activates the dye and kills the remaining bacteria without antibiotics.
Who can join: Adults aged 18 and over diagnosed with moderate gum disease (Stage II periodontitis) with gum pocket depths of 4-5 mm.
How it works: Each participant receives both treatments - standard cleaning on one side of the mouth, and standard cleaning plus PDT on the other side. This allows a fair comparison within the same person.
What is measured: Gum pocket depth, gum attachment level, and gum bleeding - checked at the start of the study and again after 3 months.
The study was conducted at Thumbay University Hospital, UAE
調査の概要
状態
詳細な説明
Detailed Description Periodontitis is a multifactorial inflammatory disease driven by a dysbiotic subgingival microbiome. Despite non-surgical periodontal therapy (NSPT) being the gold standard, complete bacterial elimination is not always achieved, and residual periodontal pathogens such as Porphyromonas gingivalis and Treponema denticola can persist post-treatment. This has led to the exploration of adjunctive therapies to enhance clinical outcomes.
Antimicrobial photodynamic therapy (aPDT) is a non-antibiotic adjunct that uses a photosensitizing dye activated by laser light of a specific wavelength. Upon activation in the presence of oxygen, the dye generates cytotoxic reactive oxygen species and singlet oxygen, which disrupt bacterial cell membranes and DNA. Indocyanine green (ICG), a near-infrared photosensitizer with peak absorption in the 800-830 nm range, demonstrates high uptake among key periodontal pathogens and carries no risk of inducing antimicrobial resistance.
Study Rationale:
Current systematic reviews on aPDT as an adjunct to NSPT report contradictory findings, often attributed to heterogeneous study designs, mixed periodontitis staging, and short follow-up periods. This study addresses these limitations by focusing exclusively on a well-defined patient population with Stage II periodontitis and employing a split-mouth design to minimize inter-subject variability.
Intervention Protocol:
Control sites (NSPT alone):
Supragingival and subgingival debridement was performed using an ultrasonic scaler, followed by subgingival root instrumentation using Gracey curettes (11/12). A customized acrylic stent with a UNC-15 mm periodontal probe was used to standardize probing measurements.
Test sites (NSPT + aPDT):
Following NSPT, indocyanine green dye was reconstituted at a concentration of 5 mg/ml and delivered into the periodontal pocket via a 27-gauge needle, placed to the base of the pocket and withdrawn coronally while injecting. The photosensitizer was then activated using an Elexxion AG 810 nm diode laser, with the fiber tip moved in an apico-coronal direction parallel to the root surface within the pocket.
Randomization:
Sites were randomly allocated to test or control groups using a split-mouth design, ensuring contralateral teeth were assigned to different treatment groups.
Follow-up:
All clinical parameters - probing pocket depth (PD), clinical attachment level (CAL), gingival recession, and bleeding on probing (BOP) - were recorded at baseline and at three months post-treatment by a calibrated examiner using standardized acrylic stents.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Ajman、アラブ首長国連邦
- Thumbay University Hospital, Postgraduate Research Centre
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- - Adults aged 18 years and older
- Diagnosis of Stage II periodontitis according to the 2018 classification of the World Workshop of Periodontology (AAP/EFP)
- At least two non-adjacent sites with interproximal probing pocket depth of 4-5 mm
- Interproximal clinical attachment loss of 3-4 mm at affected sites
- Willing and able to provide written informed consent
Exclusion Criteria:
- Periodontal therapy including scaling and root debridement within the last 12 months
- Antibiotic use or regular use of mouthwash in the 3 months prior to enrollment
- Pregnancy
- Any systemic condition that may affect periodontal healing (e.g. uncontrolled diabetes, immunocompromised states)
- Regular use of hormonal contraceptives
- Smoking more than 10 cigarettes per day
研究計画
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:クロスオーバー割り当て
- 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 |
|---|---|
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アクティブコンパレータ:NSPT Alone (Control)
Control sites received full-mouth non-surgical periodontal therapy (NSPT) consisting of supragingival and subgingival debridement using an ultrasonic scaler and Gracey curettes (Hu-Friedy, Chicago, IL).
Oral hygiene instructions were reinforced at each visit.
Pocket depth was standardized using an individualized acrylic resin occlusal stent with a UNC-15 periodontal probe.
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Full-mouth mechanical debridement using ultrasonic scaling and area-specific Gracey curettes to remove supra- and subgingival calculus and plaque biofilm.
Applied to all sites in both arms.
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実験的:NSPT + Antimicrobial Photodynamic Therapy (Test)
Test sites received full-mouth NSPT followed by adjunctive antimicrobial photodynamic therapy (aPDT).
Indocyanine green (ICG) dye was reconstituted at 5 mg/ml and delivered to the base of the periodontal pocket via a 27-gauge needle using a coronal withdrawal technique.
The photosensitizer was activated using an Elexxion AG 810 nm diode laser, with the fiber tip moved in an apico-coronal direction parallel to the root surface within the pocket.
|
Full-mouth mechanical debridement using ultrasonic scaling and area-specific Gracey curettes to remove supra- and subgingival calculus and plaque biofilm.
Applied to all sites in both arms.
Indocyanine green (ICG) photosensitizing dye (25 mg lyophilized powder reconstituted to 5 mg/ml with sterile water) was delivered into the periodontal pocket via a 27-gauge needle.
The dye was then activated using an Elexxion AG 810 nm diode laser.
The laser fiber tip was positioned at the base of the pocket and moved in an apico-coronal direction parallel to the root surface.
Applied to test sites only, immediately following NSPT.
他の名前:
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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 |
|---|---|---|
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Change in Probing Pocket Depth (PD)
時間枠:Baseline and 3 months
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Probing pocket depth measured in millimeters using a UNC-15 mm periodontal probe standardized with an individualized acrylic resin occlusal stent.
Measurements recorded at the mesio-buccal surface of the assigned tooth in both control and test sites.
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Baseline and 3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Bleeding on Probing (BOP)
時間枠:Baseline and 3 months
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Bleeding on probing recorded as a percentage of sites exhibiting bleeding following gentle probing of the periodontal pocket.
Presence or absence of bleeding noted within 30 seconds of probing at each designated site.
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Baseline and 3 months
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Change in Gingival Recession
時間枠:Baseline and 3 months
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Gingival recession measured in millimeters as the distance from the cemento-enamel junction to the free gingival margin using a UNC-15 mm periodontal probe standardized with an individualized acrylic resin occlusal stent.
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Baseline and 3 months
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Change in Clinical Attachment Level (CAL)
時間枠:Baseline and 3 months
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Clinical attachment level measured in millimeters as the distance from the cemento-enamel junction to the base of the periodontal pocket, using a UNC-15 mm periodontal probe standardized with an individualized acrylic resin occlusal stent.
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Baseline and 3 months
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
- Chambrone L, Wang HL, Romanos GE. Antimicrobial photodynamic therapy for the treatment of periodontitis and peri-implantitis: An American Academy of Periodontology best evidence review. J Periodontol. 2018 Jul;89(7):783-803. doi: 10.1902/jop.2017.170172.
- Salvi GE, Stahli A, Schmidt JC, Ramseier CA, Sculean A, Walter C. Adjunctive laser or antimicrobial photodynamic therapy to non-surgical mechanical instrumentation in patients with untreated periodontitis: A systematic review and meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:176-198. doi: 10.1111/jcpe.13236.
- Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- Mds2022-01
- 2021MDSPerio01 (その他の識別子:Gulf Medical University MDS Thesis 2023-2024)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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