Efficacy of Adjunctive Theravex Tissue Care® With Xenograft in Internal Sinus Lifting
Efficacy of Adjunctive Theravex Tissue Care® With Xenograft Using Osseodensification in Internal Sinus Lifting: a Randomized Controlled Clinical Study
調査の概要
状態
条件
詳細な説明
The posterior maxilla presents a significant clinical challenge for implant placement due to progressive alveolar resorption, sinus pneumatization, and suboptimal bone density. Addressing these deficiencies typically necessitates sinus floor augmentation to restore the vertical bone height required for achieving adequate primary stability.
Crestal sinus floor elevation via osseodensification addresses these deficiencies by preserving and compacting alveolar bone, which increases primary stability and facilitates hydrodynamic membrane elevation. To maintain the newly created vertical space, this technique is frequently combined with bone substitutes like demineralized bone matrix (DBM) xenografts. However, optimizing the biological graft-tissue interface to accelerate healing remains a critical goal.
Bone Bioactive Liquid (BBL, Theravex Tissue Care Plus) is a novel, negatively charged phosphate saline solution containing calcium and magnesium chlorides that fundamentally alters the implant-tissue interface. While Theravex is proven to enhance implant wettability, modulate inflammatory responses, and accelerate osseointegration, its potential as a biologic adjunct to hydrate the graft matrix during osseodensification-mediated sinus augmentation currently remains unexplored.
This randomized, controlled, parallel design, two-arm clinical trial (RCT) will enroll 16 partially edentulous patients. Eligible patients will have an initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT. The study will be a double-blinded clinical study, meaning blinding includes the patient and the assessor. After confirmation of eligibility and completion of baseline records, patients will be randomized 1:1 using computer-generated blocks
Participants will be allocated into the following two treatment arms:
Group I (Test Group): Patients in this group will undergo internal maxillary sinus lift via the osseodensification technique with simultaneous dental implant placement, utilizing a mixture of Theravex (Bone Bioactive Liquid) and xenograft and as the grafting material.
Group II (Control Group): Patients in this group will undergo internal maxillary sinus lift via the osseodensification technique with simultaneous dental implant placement, utilizing xenograft alone as the grafting material.
Aim of the Study:
This study will be performed to evaluate the clinical and radiographic efficacy of Theravex Tissue Care Plus (Bone Bioactive Liquid) as an adjunct to xenograft grafting in crestal maxillary sinus elevation with simultaneously implant placement using osseodensification technique.
Research Question:
In patients undergoing crestal maxillary sinus elevation via osseodensification, does adjunctive use of Theravex (bone bioactive liquid) with a xenograft enhance vertical bone gain, bone density, and implant stability compared to xenograft alone?
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Eslam Osama Hashem, Master's
- 電話番号：+201100673726
- メール：eslamhashim@dent.asu.edu.eg
研究場所
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Cairo、エジプト、11566
- Faculty Of Dentistry Ain Shams University
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.
- Both genders will be selected males and females.
- Adult patients aged between 21 and 50 years of age.
- Good general health (American Society of Anesthesiology Physical Status I-II).
- Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT.
- No previous surgery or radiation treatment on the maxillary sinus
Exclusion Criteria:
- Smokers
- Pregnant and lactating females.
- Poor oral hygiene (Full-Mouth Plaque Score (FMPS) > 20%).
- Patients with occlusal or malalignment problems.
- Patients with parafunctional habits.
- Presence of acute or chronic sinus pathoses or sinus membrane perforation.
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：並列代入
- マスキング：ダブル
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：Theravex - Xenograft mixture group
Patients in this group will undergo internal maxillary sinus lift via the osseodensification technique with simultaneous dental implant placement, utilizing a mixture of Theravex (Bone Bioactive Liquid) and xenograft and as the grafting material.
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Application of a grafting mixture consisting of an equine granulate xenograft hydrated with Theravex (Bone Bioactive Liquid) into the osteotomy site.
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アクティブコンパレータ：Xenograft alone group
Patients in this group will undergo internal maxillary sinus lift via the osseodensification technique with simultaneous dental implant placement, utilizing xenograft alone as the grafting material.
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Application of an equine granulate xenograft alone into the osteotomy site.
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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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Implant Stability Quotient (ISQ)
時間枠：Immediate post-operative and 3 months post-operative
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ISQ will be recorded at baseline immediately post-operative.
Repeating ISQ measurements will be taken for 3 months post-operatively to evaluate the transition from primary to secondary stability
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Immediate post-operative and 3 months post-operative
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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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Bone Density
時間枠：Immediate post-operative and 6 months post-operative
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Bone density will be assessed at 6 months using cone-beam computed tomography (CBCT). Bone density at the apical region of the implant (the area of vertical bone gain) will be measured immediately and 6 months post-operatively using OnDemand 3D software. Values will be recorded in Hounsfield Units (HU), comparing pre-operative (via virtual implant) and post-operative scans. To determine the mean peri-implant bone density, measurements from four standardized reference points (mesial, distal, buccal, and palatal) will be averaged. |
Immediate post-operative and 6 months post-operative
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Vertical Bone Gain
時間枠：Immediate post operative and 6 months after surgery
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VBG will be assessed at baseline (immediate post operative and 6 months after surgery) Specialized 3D imaging software will be utilized to superimpose the pre-operative and immediate post-operative cone-beam computed tomography (CBCT) scans.
This digital superimposition will facilitate a precise comparison of dimensional changes at the specific implant sites, enabling accurate measurement and quantification of the vertical bone height achieved following the sinus elevation.
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Immediate post operative and 6 months after surgery
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Oral-health-related quality of life OHIP-14
時間枠：Baseline (before surgery), 7 days, 3 months and 6 months post-operative.
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Will be assessed using the OHIP-14 questionnaire
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Baseline (before surgery), 7 days, 3 months and 6 months post-operative.
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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
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- FDASU-RecIM335152
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