Effect of Theravex Tissue Care on Implant Stability

July 14, 2026 updated by: Abdallah Abdelnabi, Ain Shams University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Susan M Sarhan

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Faculty of Dentistry - Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Other Names:
  • Theravex
Procedure: Immediate Implant Placement
Surgical placement of the dental implant into the fresh extraction socket immediately following tooth extraction, according to standard surgical protocols.
Active Comparator: 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.
Procedure: Immediate Implant Placement
Surgical placement of the dental implant into the fresh extraction socket immediately following tooth extraction, according to standard surgical protocols.
Device: Bovine-derived Xenograft
Bovine derived- xenograft will be packed into the jumping gap to maintain volume and provide an osteoconductive scaffold for bone formation.
Experimental: 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).
Device: 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.
Other Names:
  • Theravex
Procedure: Immediate Implant Placement
Surgical placement of the dental implant into the fresh extraction socket immediately following tooth extraction, according to standard surgical protocols.
Device: Bovine-derived Xenograft
Bovine derived- xenograft will be packed into the jumping gap to maintain volume and provide an osteoconductive scaffold for bone formation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (during surgery), 4 weeks, 3 months, and 6 months post-operatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Density
Time Frame: 6 months post-operatively.
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
Time Frame: Baseline (immediately post-operative), 3 months, and 6 months post-operatively.
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)
Time Frame: Pre-operatively (baseline), 7 days, 3 months, and 6 months post-operatively.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Hadir F Eldessouky, Faculty of Dentistry - Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 12, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 8, 2027

Study Registration Dates

First Submitted

July 9, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-ReclM15423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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