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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theravex Group | Experimental | Patients in this group will receive immediate implant placement where the jumping gap will be filled solely using Bone Bioactive Liquid (Theravex) to evaluate its effect on early osseointegration. |
|
| Xenograft Group | Active Comparator | Patients in this group will receive immediate implant placement where the jumping gap will be grafted using a standard bovine-derived xenograft bone mineral. |
|
| Combination Therapy Group | Experimental | Patients in this group will receive immediate implant placement where the jumping gap will be grafted using a combination of the bovine-derived xenograft hydrated with the Bone Bioactive Liquid (Theravex). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Bioactive Liquid | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Stability Quotient (ISQ) | Implant stability will be measured using Resonance Frequency Analysis (RFA) to record the Implant Stability Quotient (ISQ) values. | Baseline (during surgery), 4 weeks, 3 months, and 6 months post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Density | Radiographic evaluation of peri-implant bone density within the jumping gap utilizing standardized low-dose Cone-Beam Computed Tomography (CBCT) scans. | 6 months post-operatively. |
| Mid-facial Gingival Margin Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdallah A Aref, M.D.S | Contact | 00201111711467 | abdallah.aref.std@dent.asu.edu.eg | |
| Susan M Sarhan | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Hadir F Eldessouky | Faculty of Dentistry - Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry - Ain Shams University | Cairo | 11566 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38448125 | Background | 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. | |
| 40422855 |
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| ID | Term |
|---|---|
| C564254 | Capillary Malformation-Arteriovenous Malformation |
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| Bovine-derived Xenograft | Device | Bovine derived- xenograft will be packed into the jumping gap to maintain volume and provide an osteoconductive scaffold for bone formation. |
|
| Immediate Implant Placement | Procedure | Surgical placement of the dental implant into the fresh extraction socket immediately following tooth extraction, according to standard surgical protocols. |
|
Assessment of mid-facial tissue recession and soft-tissue alterations evaluated using superimposed standardized intra-oral digital scans with predefined reference points.
| Baseline (immediately post-operative), 3 months, and 6 months post-operatively. |
| Oral Health-Related Quality of Life (OHIP-14) | Patient-reported oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The scale consists of 14 items, with each item scored on a 5-point Likert scale from 0 (never) to 4 (very often). The total score is calculated by summing the scores of all items, ranging from a minimum value of 0 to a maximum value of 56. Higher scores represent a worse outcome (greater negative impact on oral health-related quality of life), while lower scores represent a better outcome. | Pre-operatively (baseline), 7 days, 3 months, and 6 months post-operatively. |
| 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. |
| 34492371 | Background | 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. |