Effect of Theravex Tissue Care on Implant Stability

N/ANot Yet RecruitingNCT07707388

Ain Shams University30 enrolled

Overview

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.

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.

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

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Implant Stability Quotient (ISQ)

Implant stability will be measured using Resonance Frequency Analysis (RFA) to record the Implant Stability Quotient (ISQ) values.

Time frame: Baseline (during surgery), 4 weeks, 3 months, and 6 months post-operatively.

Secondary Outcomes

Bone Density

Radiographic evaluation of peri-implant bone density within the jumping gap utilizing standardized low-dose Cone-Beam Computed Tomography (CBCT) scans.

Time frame: 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.

Time frame: 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.

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