NCT07707388

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Nov 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

November 12, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2027

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

July 9, 2026

Last Update Submit

July 14, 2026

Conditions

Immediate Dental Implant Placement

Keywords

immediateimplantgapjumpingsockettheravexxenograft

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (3)

  • Bone Density

    6 months post-operatively.

  • Mid-facial Gingival Margin Level

    Baseline (immediately post-operative), 3 months, and 6 months post-operatively.

  • Oral Health-Related Quality of Life (OHIP-14)

    Pre-operatively (baseline), 7 days, 3 months, and 6 months post-operatively.

Study Arms (3)

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.

Device: Bone Bioactive LiquidProcedure: 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.

Device: Bovine-derived XenograftProcedure: 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).

Device: Bone Bioactive LiquidDevice: Bovine-derived XenograftProcedure: Immediate Implant Placement

Interventions

Bone Bioactive LiquidDEVICE

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.

Also known as: Theravex
Combination Therapy GroupTheravex Group
Bovine-derived XenograftDEVICE

Bovine derived- xenograft will be packed into the jumping gap to maintain volume and provide an osteoconductive scaffold for bone formation.

Combination Therapy GroupXenograft Group
Immediate Implant PlacementPROCEDURE

Surgical placement of the dental implant into the fresh extraction socket immediately following tooth extraction, according to standard surgical protocols.

Combination Therapy GroupTheravex GroupXenograft Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry - Ain Shams University

Cairo, 11566, Egypt

Location

Related Publications (3)

  • 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: 38448125BACKGROUND

  • 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: 40422855BACKGROUND

  • 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: 34492371BACKGROUND

MeSH Terms

Conditions

Capillary Malformation-Arteriovenous Malformation

Study Officials

  • Hadir F Eldessouky

    Faculty of Dentistry - Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Abdallah A Aref, M.D.S

CONTACT

00201111711467abdallah.aref.std@dent.asu.edu.eg

Susan M Sarhan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Periodontology

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 16, 2026

Study Start (Estimated)

November 12, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 8, 2027

Last Updated

July 16, 2026

Record last verified: 2026-07

Locations

EG(1)