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Effect of Theravex Tissue Care on Implant Stability

14. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Susan M Sarhan

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Andre navne:
  • 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.
Aktiv komparator: 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.
Enhed: Bovine-derived Xenograft
Bovine derived- xenograft will be packed into the jumping gap to maintain volume and provide an osteoconductive scaffold for bone formation.
Eksperimentel: 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).
Enhed: 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.
Andre navne:
  • 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.
Enhed: Bovine-derived Xenograft
Bovine derived- xenograft will be packed into the jumping gap to maintain volume and provide an osteoconductive scaffold for bone formation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Implant Stability Quotient (ISQ)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bone Density
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ain Shams University

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

12. november 2026

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

8. september 2027

Datoer for studieregistrering

Først indsendt

9. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FDASU-ReclM15423

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Kliniske forsøg med Umiddelbar tandimplantatplacering

Kliniske forsøg med Bone Bioactive Liquid

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