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

13. september 2026 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
    • Merkez
      • Adıyaman, Merkez, Tyrkia (Türkiye), 02030
        • Faculty of Dentistry, Adıyaman University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: 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.
Fremgangsmåte: Conventional Implant Placement
Implants were placed using the standard surgical protocol, followed by standard postoperative care, without intraoperative or postoperative ozone application.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Adiyaman University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. september 2025

Primær fullføring (Faktiske)

18. mai 2026

Studiet fullført (Faktiske)

18. mai 2026

Datoer for studieregistrering

Først innsendt

30. juni 2026

Først innsendt som oppfylte QC-kriteriene

30. juni 2026

Først lagt ut (Faktiske)

7. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HRU-25.14.63

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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