Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy
Use of Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy
調査の概要
状態
詳細な説明
This prospective clinical trial will include systemically healthy adult patients who require extraction of at least two posterior teeth with a hopeless prognosis due to periodontal disease, root caries, or root fractures, and who are candidates for implant-supported posterior rehabilitation. Following atraumatic tooth extraction, only sites with intact alveolar socket walls will be included.
Extracted teeth will be processed to obtain an autogenous odontogenic graft material. Eligible extraction sockets will be allocated to one of the study groups: (1) odontogenic graft alone or (2) odontogenic graft combined with adjunctive low-level laser therapy. In the laser group, LLLT will be applied according to a standardized protocol during the early healing period to promote cellular activity and bone regeneration.
Clinical and radiographic evaluations will be performed at baseline and at predefined follow-up intervals to assess soft tissue healing, bone dimensional changes, and quality of regenerated bone prior to implant placement. The primary outcome measure will be the amount and quality of newly formed bone, while secondary outcomes will include socket healing, postoperative morbidity, and implant feasibility.
The results of this study aim to provide clinical evidence on the potential benefits of combining autogenous tooth-derived grafts with low-level laser therapy for alveolar ridge preservation and to support optimized treatment protocols for implant-supported posterior rehabilitation.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Uskudar
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Istanbul、Uskudar、トルコ（Türkiye）、34668
- Health Sciences University
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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:
- Patients requiring tooth extraction due to periodontal reasons (teeth with a hopeless prognosis), root caries, or root fractures, who are simultaneously candidates for posterior replacement with an osseointegrated implant, and who require extraction of at least two teeth.
- Integrity of the alveolar socket walls following tooth extraction.
- Patients who accept the study conditions, sign written informed consent, and agree to attend the scheduled follow-up visits.
Exclusion Criteria:
- General contraindications for dental and/or surgical treatments.
- Inflammatory or autoimmune diseases of the oral cavity.
- Uncontrolled diabetes mellitus (HbA1c > 7%).
- History of malignancy requiring chemotherapy or radiotherapy within the past 5 years.
- Previous treatment with immunosuppressive agents, bisphosphonates, or high-dose corticosteroids.
- Smoking more than 10 cigarettes per day.
- Pregnant or breastfeeding women.
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Control Group
Dentin graft socket preservation
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Autogenous Tooth-Derived Bone Graft prepared using the BonMaker® ATB device from extracted human teeth.
Following atraumatic tooth extraction, teeth will be mechanically ground and chemically processed according to the manufacturer's standardized protocol to obtain particulate autogenous graft material containing dentin and enamel components.
The graft material will be placed immediately into extraction sockets for alveolar ridge preservation prior to implant placement.
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実験的：Test Group
Dentin graft socket preservation+LLLT
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Adjunctive low-level laser therapy (LLLT) performed using a 650 nm diode laser device (Woodpecker DTE D-Laser Blue) with a 6 mm fiber applicator in continuous contact mode at an output power of 25 mW and an energy density of 0.500 J/cm².
Laser irradiation will be applied to grafted extraction sockets immediately after extraction, after flap closure, and during postoperative follow-up visits according to a standardized treatment protocol to enhance soft tissue healing and bone regeneration.
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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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Mean change in horizontal alveolar ridge width (mm) from baseline to 4 months (CBCT)
時間枠：Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)
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Horizontal alveolar ridge width will be measured in millimeters using cone-beam computed tomography (CBCT) at baseline (immediately after tooth extraction) and at 4 months postoperatively prior to implant placement. The primary outcome will be defined as the mean change in ridge width (Δ width = width at 4 months - width at baseline), expressed in millimeters. |
Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)
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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 |
|---|---|---|
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Mean change in vertical alveolar ridge height (mm) from baseline to 4 months (CBCT)
時間枠：Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]
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Vertical alveolar ridge height will be measured in millimeters using cone-beam computed tomography (CBCT) at baseline (immediately after tooth extraction) and at 4 months postoperatively prior to implant placement. The secondary outcome will be defined as the mean change in ridge height (Δ height = height at 4 months - height at baseline), expressed in millimeters. |
Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Newly Formed Bone Measured by Histomorphometric Analysis of Bone Biopsy Specimens
時間枠：Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]
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Bone biopsy specimens obtained from grafted extraction sockets during implant placement surgery will be processed with hematoxylin and eosin (H&E) staining and evaluated under light microscopy.
Histomorphometric analysis will be used to quantify the percentage of newly formed bone within the biopsy samples.
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Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)]
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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