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Ozone Versus Conventional Socket Disinfection for Primary Dental Implant Stability

30. juni 2026 opdateret af: Zeliha Başak Çakır Erdil

Comparison of Ozone and Conventional Socket Disinfection in Dental Implant Placement in Terms of Primary Stability

This randomized split-mouth controlled clinical trial aims to compare the effects of ozone and conventional implant site disinfection on primary and early secondary implant stability. Systemically healthy adults requiring at least two dental implants in symmetrical or contralateral edentulous sites will receive ozone disinfection at one implant site and conventional disinfection at the paired site according to a randomized allocation. Implant stability will be assessed immediately after implant placement using insertion torque and resonance frequency analysis (Implant Stability Quotient, ISQ), and secondary stability will be evaluated by ISQ measurements at the 3-month follow-up during healing abutment placement. The study will determine whether ozone disinfection improves implant stability during the early osseointegration period.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Primary implant stability is a key determinant of successful osseointegration and long-term implant survival. Various implant site disinfection methods have been proposed to reduce the microbial load before implant placement. Ozone possesses antimicrobial and biostimulatory properties and may improve the biological environment for implant healing compared with conventional implant site disinfection.

The purpose of this randomized split-mouth controlled clinical trial is to compare ozone implant site disinfection with conventional implant site disinfection in terms of primary and early secondary implant stability.

Systemically healthy adults requiring at least two dental implants in symmetrical or contralateral edentulous sites will be enrolled. According to a randomized split-mouth design, one implant site will receive ozone disinfection before implant placement, whereas the paired implant site will receive conventional disinfection. This design allows each participant to serve as their own control, thereby minimizing inter-individual variability.

Primary implant stability will be assessed immediately after implant placement using insertion torque measurements and resonance frequency analysis (Implant Stability Quotient, ISQ). Secondary implant stability will be evaluated by resonance frequency analysis at the 3-month follow-up during healing abutment placement. All clinical procedures will be standardized and performed by experienced clinicians. The study aims to determine whether ozone implant site disinfection provides superior implant stability during the early osseointegration period compared with conventional implant site disinfection.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

51

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Tyrkiet (Türkiye)
    • Merkez
      • Adıyaman, Merkez, Tyrkiet (Türkiye), 02030
        • Faculty of Dentistry, Adıyaman 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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Systemically healthy individuals requiring at least two dental implants.
  • Presence of symmetrical or contralateral edentulous sites suitable for dental implant placement.
  • Adequate bone volume for implant placement without the need for simultaneous bone augmentation.
  • Ability and willingness to provide written informed consent and comply with the study protocol.

Exclusion Criteria:

  • Adults aged 18 years or older.
  • Systemically healthy individuals requiring at least two dental implants.
  • Presence of symmetrical or contralateral edentulous sites suitable for dental implant placement.
  • Adequate bone volume for implant placement without the need for simultaneous bone augmentation.
  • Ability and willingness to provide written informed consent and comply with the study protocol.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ozone Disinfection
Implant sites assigned to the experimental intervention receive ozone disinfection before dental implant placement.
Procedure: Ozone Implant Site Disinfection
Before dental implant placement, the implant site assigned to the experimental intervention is disinfected using ozone according to the study protocol. In this randomized split-mouth design, each participant receives ozone disinfection at one implant site, while the paired contralateral or symmetrical implant site receives conventional disinfection. Implant stability is evaluated immediately after implant placement using insertion torque and resonance frequency analysis (ISQ), and again after 3 months using ISQ.
Eksperimentel: Conventional Disinfection
Implant sites assigned to the control intervention receive conventional implant site disinfection before dental implant placement.
Procedure: Conventional Socket Disinfection
Before dental implant placement, the implant site assigned to the control intervention is disinfected using the conventional disinfection protocol. In this randomized split-mouth design, each participant receives conventional disinfection at one implant site, while the paired contralateral or symmetrical implant site receives ozone disinfection. Implant stability is evaluated immediately after implant placement using insertion torque and resonance frequency analysis (ISQ), and again after 3 months using ISQ.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Implant Stability (Insertion Torque)
Tidsramme: Immediately after implant placement
Primary implant stability will be assessed immediately after implant placement by measuring insertion torque (Ncm).
Immediately after implant placement

Samarbejdspartnere og efterforskere

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

Sponsor

Zeliha Başak Çakır Erdil

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 (Faktiske)

18. november 2025

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

1. august 2026

Datoer for studieregistrering

Først indsendt

30. juni 2026

Først indsendt, der opfyldte QC-kriterier

30. juni 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • HRU-25.18.55

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be made publicly available because of participant confidentiality and institutional data-sharing policies.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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