Effect of Theravex Tissue Care on Implant Stability
Effect of Theravex Tissue Care on Implant Stability in Immediate Implant Placement: A Randomized Controlled Clinical Trial
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Abdallah A Aref, M.D.S
- Telefonní číslo: 00201111711467
- E-mail: abdallah.aref.std@dent.asu.edu.eg
Studijní záloha kontaktů
- Jméno: Susan M Sarhan
Studijní místa
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Cairo, Egypt, 11566
- Faculty of Dentistry - Ain Shams University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Theravex Group
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.
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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.
Ostatní jména:
Surgical placement of the dental implant into the fresh extraction socket immediately following tooth extraction, according to standard surgical protocols.
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Aktivní komparátor: Xenograft Group
Patients in this group will receive immediate implant placement where the jumping gap will be grafted using a standard bovine-derived xenograft bone mineral.
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Surgical placement of the dental implant into the fresh extraction socket immediately following tooth extraction, according to standard surgical protocols.
Bovine derived- xenograft will be packed into the jumping gap to maintain volume and provide an osteoconductive scaffold for bone formation.
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Experimentální: Combination Therapy Group
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).
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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.
Ostatní jména:
Surgical placement of the dental implant into the fresh extraction socket immediately following tooth extraction, according to standard surgical protocols.
Bovine derived- xenograft will be packed into the jumping gap to maintain volume and provide an osteoconductive scaffold for bone formation.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Implant Stability Quotient (ISQ)
Časové okno: Baseline (during surgery), 4 weeks, 3 months, and 6 months post-operatively.
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Implant stability will be measured using Resonance Frequency Analysis (RFA) to record the Implant Stability Quotient (ISQ) values.
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Baseline (during surgery), 4 weeks, 3 months, and 6 months post-operatively.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Bone Density
Časové okno: 6 months post-operatively.
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Radiographic evaluation of peri-implant bone density within the jumping gap utilizing standardized low-dose Cone-Beam Computed Tomography (CBCT) scans.
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6 months post-operatively.
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Mid-facial Gingival Margin Level
Časové okno: Baseline (immediately post-operative), 3 months, and 6 months post-operatively.
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Assessment of mid-facial tissue recession and soft-tissue alterations evaluated using superimposed standardized intra-oral digital scans with predefined reference points.
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Baseline (immediately post-operative), 3 months, and 6 months post-operatively.
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Oral Health-Related Quality of Life (OHIP-14)
Časové okno: Pre-operatively (baseline), 7 days, 3 months, and 6 months post-operatively.
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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.
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Pre-operatively (baseline), 7 days, 3 months, and 6 months post-operatively.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Hadir F Eldessouky, Faculty of Dentistry - Ain Shams University
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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