Effect of Theravex Tissue Care on Implant Stability

Официальное название

Effect of Theravex Tissue Care on Implant Stability in Immediate Implant Placement: A Randomized Controlled Clinical Trial

Обзор

The aim of this randomized clinical trial is to evaluate the clinical and radiographic outcomes of using Bone Bioactive Liquid (Theravex) compared to Xenograft and a combination therapy (Theravex + Xenograft) during immediate implant placement in the esthetic zone. When a tooth is extracted and replaced immediately with a dental implant, bone grafting is often necessary to fill the gap (jumping distance) between the implant and the surrounding bone socket to support tissue healing and maintain facial contour. Participants requiring immediate implant placement will be randomly assigned into three groups: Group 1: Immediate implant placement using Bone Bioactive Liquid (Theravex). Group 2: Immediate implant placement using Xenograft alone. Group 3: Immediate implant placement using Combination Therapy (Theravex + Xenograft). The primary outcomes will evaluate implant stability, bone dimensional changes, and soft tissue response around the implants over the follow-up period.

Подробное описание

Background and Rationale:

Immediate implant placement in extraction sockets has become a widely accepted clinical protocol due to reduced treatment time, fewer surgical interventions, and preservation of surrounding hard and soft tissue architecture. However, post-extraction bone remodeling often leads to horizontal and vertical dimensional changes, particularly at the buccal bone plate. To counteract these changes and ensure long-term stability and esthetics, grafting the peri-implant defect (jumping space) is commonly performed.

Study Objectives:

The main objective of this study is to compare the efficacy of Bone Bioactive Liquid (Theravex), Xenograft material, and their combination in enhancing early osseointegration, maintaining bone dimensions, and supporting peri-implant tissue health during immediate implant placement.

Methodology:

Following thorough clinical and radiographic evaluations (including CBCT scans), eligible patients requiring single-tooth extraction and immediate implant placement in the esthetic zone will be enrolled. Surgical procedures will follow standard aseptic protocols. After atraumatic tooth extraction and precise osteotomy preparation, dental implants will be placed according to standard manufacturer guidelines.

Patients will be randomly allocated into three intervention arms:

Group A: Receives Bone Bioactive Liquid (Theravex) in the peri-implant gap.

Group B: Receives Xenograft material alone.

Group C: Receives Combination Therapy (Theravex combined with Xenograft).

Follow-up \& Assessments:

Baseline clinical parameters (e.g., primary stability via ISQ/RFA) and initial CBCT measurements will be recorded. Patients will be evaluated postoperatively at standardized time intervals to assess secondary stability, soft tissue healing, peri-implant mucosal parameters, and marginal bone level changes using standardized radiographic imaging.

Вмешательства

• Устройство Bone Bioactive Liquid
  A bone bioactive liquid (Theravex) applied directly into the jumping gap and on implant surface immediately following implant placement to stimulate early bone healing and osseointegration.
• Устройство Bovine-derived Xenograft
  Bovine derived- xenograft will be packed into the jumping gap to maintain volume and provide an osteoconductive scaffold for bone formation.
• Процедура Immediate Implant Placement
  Surgical placement of the dental implant into the fresh extraction socket immediately following tooth extraction, according to standard surgical protocols.

Первичные конечные точки

• Implant Stability Quotient (ISQ) [Срок оценки: Baseline (during surgery), 4 weeks, 3 months, and 6 months post-operatively.]

Вторичные конечные точки (3)

• Bone Density [Срок оценки: 6 months post-operatively.]
• Mid-facial Gingival Margin Level [Срок оценки: Baseline (immediately post-operative), 3 months, and 6 months post-operatively.]
• Oral Health-Related Quality of Life (OHIP-14) [Срок оценки: Pre-operatively (baseline), 7 days, 3 months, and 6 months post-operatively.]

Критерии участия

Критерии включения

• Patient requires extraction of a single failing or non-restorable maxillary anterior tooth or premolar.
• Presence of an intact buccal bone plate (Socket Type I) with a horizontal peri-implant jumping gap ≥ 2 mm.
• The implant can be placed in an ideal 3-D position with an intraoperative primary stability target of ≥ 35 Ncm.
• Patient is in good general health with no systemic contraindications to implant surgery.
• Patient is cooperative and available for the entire 6-month follow-up period

Критерии исключения

• Pregnant and lactating females.
• Heavy smokers (smoking ≥ 10 cigarettes per day).
• Patients with poor oral hygiene.
• Patients with occlusal or malalignment problems.
• Patients with parafunctional habits (e.g., bruxism).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dentistry - Ain Shams University — Cairo

Публикации

• Alqutaibi AY, Allam H, Almuzaini SA. IMMEDIATE IMPLANT PLACEMENT WITH A SIMULTANEOUS BONE AUGMENTATION OF THE GAP-FILLING SITES CAN POTENTIALLY DECREASE BONE LOSS COMPARED WITH AUGMENTED SITES EXHIBITING GAPS WITH BONY DEFECTS. J Evid Based Dent Pract. 2024 Mar;24(1):101959. doi: 10.1016/j.jebdp.2023.101959. Epub 2023 Dec 21. PMID 38448125
• Al Madhoun A, Meshal K, Carrio N, Ferres-Amat E, Ferres-Amat E, Barajas M, Jimenez-Escobar AL, Al-Madhoun AS, Saber A, Abou Alsamen Y, Marti C, Atari M. Correction: Al Madhoun et al. Randomized Clinical Trial: Bone Bioactive Liquid Improves Implant Stability and Osseointegration. J. Funct. Biomater. 2024, 15, 293. J Funct Biomater. 2025 May 9;16(5):171. doi: 10.3390/jfb16050171. PMID 40422855
• Ji H, Wang Y, Liu H, Liu Y, Zhang X, Xu J, Li Z, Luo E. Programmed core-shell electrospun nanofibers to sequentially regulate osteogenesis-osteoclastogenesis balance for promoting immediate implant osseointegration. Acta Biomater. 2021 Nov;135:274-288. doi: 10.1016/j.actbio.2021.08.050. Epub 2021 Sep 4. PMID 34492371

Идентификаторы

NCT: NCT07707388 · FDASU-ReclM15423

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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