Immediate Dental Implant PlacementNCT07707388
Effect of Theravex Tissue Care on Implant Stability
A study testing Bone Bioactive Liquid, Bovine-derived Xenograft and Immediate Implant Placement in people with Immediate Dental Implant Placement, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant Placement
- What is being tested?
- Bone Bioactive Liquid, Bovine-derived Xenograft and Immediate Implant Placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Nov 2026to 8 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Susan M Sarhan contact
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Immediate Dental Implant Placement
- Being tested
- Bone Bioactive Liquid, Bovine-derived Xenograft, Immediate Implant Placement
- Keywords
- immediate, implant, gap, jumping, socket, theravex, xenograft
- Medical subject headings
- Capillary Malformation-Arteriovenous Malformation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Bioactive LiquidDevice
Also called Theravex
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.
Bovine-derived XenograftDevice
Bovine derived- xenograft will be packed into the jumping gap to maintain volume and provide an osteoconductive scaffold for bone formation.
Immediate Implant PlacementProcedure or surgery
Surgical placement of the dental implant into the fresh extraction socket immediately following tooth extraction, according to standard surgical protocols.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Bone Bioactive Liquid; Procedure: Immediate Implant Placement |
| 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. Receives: Device: Bovine-derived Xenograft; Procedure: Immediate Implant Placement |
| 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). Receives: Device: Bone Bioactive Liquid; Device: Bovine-derived Xenograft; Procedure: Immediate Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability Quotient (ISQ)
Implant stability will be measured using Resonance Frequency Analysis (RFA) to record the Implant Stability Quotient (ISQ) values.
Measured: Baseline (during surgery), 4 weeks, 3 months, and 6 months post-operatively.
Secondary outcomes (3)
Bone Density
Radiographic evaluation of peri-implant bone density within the jumping gap utilizing standardized low-dose Cone-Beam Computed Tomography (CBCT) scans.
Measured: 6 months post-operatively.
Mid-facial Gingival Margin Level
Assessment of mid-facial tissue recession and soft-tissue alterations evaluated using superimposed standardized intra-oral digital scans with predefined reference points.
Measured: 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.
Measured: Pre-operatively (baseline), 7 days, 3 months, and 6 months post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start12 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion8 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Immediate Dental Implant PlacementStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Abdelnabi, Ain Shams University
- Investigators
- Hadir F Eldessouky, Study director, Faculty of Dentistry - Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707388
- Sponsor's protocol ID
- FDASU-ReclM15423
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38448125Al 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.
PubMed 40422855Ji 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.
PubMed 34492371
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Theravex Tissue Care on Implant Stability in Immediate Implant Placement: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07707388
- Acronym / sponsor ID
- FDASU-ReclM15423
- Conditions
- Immediate Dental Implant Placement
- Keywords
- immediate, implant, gap, jumping, socket, theravex, xenograft
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 8 Sep 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Theravex Group | Experimental | Device: Bone Bioactive Liquid, Procedure: Immediate Implant PlacementPatients 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 | Device: Bovine-derived Xenograft, Procedure: Immediate Implant PlacementPatients 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 | Device: Bone Bioactive Liquid, Device: Bovine-derived Xenograft, Procedure: Immediate Implant PlacementPatients 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Bioactive LiquidAlso: TheravexA 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. | Device | Combination Therapy Group, Theravex Group |
| Bovine-derived XenograftBovine derived- xenograft will be packed into the jumping gap to maintain volume and provide an osteoconductive scaffold for bone formation. | Device | Combination Therapy Group, Xenograft Group |
| Immediate Implant PlacementSurgical placement of the dental implant into the fresh extraction socket immediately following tooth extraction, according to standard surgical protocols. | Procedure or surgery | Combination Therapy Group, Theravex Group, Xenograft Group |
Primary outcome
Implant Stability Quotient (ISQ)
Time frame: Baseline (during surgery), 4 weeks, 3 months, and 6 months post-operatively.
Implant stability will be measured using Resonance Frequency Analysis (RFA) to record the Implant Stability Quotient (ISQ) values.
3 secondary outcomes
Bone Density
Time frame: 6 months post-operatively.
Mid-facial Gingival Margin Level
Time frame: Baseline (immediately post-operative), 3 months, and 6 months post-operatively.
Oral Health-Related Quality of Life (OHIP-14)
Time frame: Pre-operatively (baseline), 7 days, 3 months, and 6 months post-operatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 38448125Alqutaibi 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.
- Background: PubMed 40422855Al 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.
- Background: PubMed 34492371Ji 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan M Sarhan contact
Hadir F Eldessouky study director
Faculty of Dentistry - Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Bioactive Liquid, Bovine-derived Xenograft and Immediate Implant Placement in people with Immediate Dental Implant Placement, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdallah A Aref, M.D.S (00201111711467, abdallah.aref.std@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability Quotient (ISQ) (time frame: Baseline (during surgery), 4 weeks, 3 months, and 6 months post-operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07707388, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.