Health TrialsbyHealthPanel

Effect of Theravex Tissue Care on Implant Stability

ConditionImmediate Dental Implant Placement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAin Shams University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnant and lactating females.

Heavy smokers (smoking ≥ 10 cigarettes per day).

Patients with poor oral hygiene.

Patients with occlusal or malalignment problems.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bone Bioactive Liquid

    Device

    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 Xenograft

    Device

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

  • Immediate Implant Placement

    Procedure/Surgery

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

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Theravex GroupExperimental treatment 2 interventions
Group B: Xenograft GroupActive comparator 2 interventions
Group C: Combination Therapy GroupExperimental treatment 3 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.
2

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.
3

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: