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CBCT Assessment of Marginal Bone Changes With Ozone Therapy (ozone-ımplant)

13. september 2026 opdateret af: Zeliha Başak Çakır Erdil, Adiyaman University

CBCT Assessment of Peri-Implant Marginal Bone Changes Following Adjunctive Local Ozone Therapy: A Randomized Split-Mouth Clinical Trial

This study examined whether adding local gaseous ozone to standard dental implant treatment could reduce early bone loss around implants. Fifty adults requiring matched implants on opposite sides of the same jaw participated. Within each participant, matched implant sites were randomly assigned to ozone treatment or standard treatment without ozone. Ozone was applied to the prepared implant socket during surgery and to the peri-implant surgical site after suturing and on postoperative days 1, 3, 5, and 7. Changes in marginal bone levels from baseline to 6 months were assessed using cone-beam computed tomography (CBCT).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This prospective, split-mouth randomized clinical trial was conducted at the Department of Periodontology, Faculty of Dentistry, Adıyaman University. Participants required implant placement at matched contralateral posterior sites within the same jaw. Within each participant, matched implant sites were randomly allocated to adjunctive local gaseous ozone treatment or standard treatment without ozone. Ozone was applied to the prepared implant socket during surgery and to the peri-implant surgical site after suturing and on postoperative days 1, 3, 5, and 7. Fifty participants were enrolled; two were lost to follow-up, and 48 participants with 152 implants completed the study. The final analysis included 76 ozone-treated and 76 control implants. The primary outcome was the change in peri-implant marginal bone level from baseline to 6 months, assessed using cone-beam computed tomography at the buccal, palatal/lingual, mesial, and distal implant surfaces. The outcome assessor was blinded to treatment allocation.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

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

Ja

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 to 65 years.
  • Systemically healthy individuals.
  • Ability to comply with the study procedures and follow-up visits.
  • Requirement for implant placement at matched contralateral posterior sites within the same jaw.
  • Healed edentulous sites suitable for conventional implant placement.
  • Adequate alveolar bone volume for placement of implants measuring 3.5-4.0 mm in diameter and 8-12 mm in length without the need for advanced bone augmentation, with at least 1.5 mm of surrounding bone.
  • Initial soft-tissue thickness of at least 2 mm and keratinized mucosal width of at least 2 mm at the implant sites.
  • Provision of written informed consent.

Exclusion Criteria:

  • Systemic diseases or medical conditions contraindicating implant surgery.
  • Pregnancy.
  • Smoking.
  • Active oral infection or advanced periodontal disease.
  • Insufficient bone volume requiring advanced bone augmentation.
  • Incomplete healing at the intended implant site following recent tooth extraction.
  • Previous implant failure at the intended implant site.
  • Any contraindication to ozone therapy.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gaseous Ozone Application
Within each participant, one or more matched implant sites were randomly allocated to adjunctive local gaseous ozone treatment. Ozone was applied to the surgically prepared implant socket before implant placement and to the peri-implant surgical site after suturing and on postoperative days 1, 3, 5, and 7. All sites also received standard surgical and postoperative care.
Procedure: Gaseous Ozone Application
Gaseous ozone was applied to the surgically prepared implant socket before implant placement. Following suturing, ozone was applied locally to the peri-implant surgical site and was repeated on postoperative days 1, 3, 5, and 7.
Aktiv komparator: Conventional Implant Placement
Within each participant, the corresponding contralateral matched implant site or sites were allocated to the control treatment. These sites received conventional implant placement and standard postoperative care without ozone application at any time point.
Procedure: Conventional Implant Placement
Implants were placed using the standard surgical protocol, followed by standard postoperative care, without intraoperative or postoperative ozone application.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Marginal Bone Level Around Dental Implants
Tidsramme: Baseline and 6 months after implant placement
Using cone-beam computed tomography (CBCT), the vertical distance from the implant shoulder to the first bone-to-implant contact was measured in millimeters at the buccal, palatal/lingual, mesial, and distal surfaces at baseline and 6 months. For each surface, marginal bone level change was calculated as the 6-month distance minus the baseline distance; positive values indicated greater marginal bone loss. Combined buccolingual and mesiodistal measurements were calculated by averaging the corresponding surface measurements. Changes were compared between matched ozone-treated and control implant sites.
Baseline and 6 months after implant placement

Samarbejdspartnere og efterforskere

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

Sponsor

Adiyaman University

Efterforskere

  • Ledende efterforsker: METİN ÇALIŞIR, PhD, Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey

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)

3. september 2025

Primær færdiggørelse (Faktiske)

18. maj 2026

Studieafslutning (Faktiske)

18. maj 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)

16. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HRU-25.14.63

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared because the informed consent obtained from participants did not include external sharing of individual-level data. Aggregated study findings will be reported in the publication.

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