CBCT Assessment of Marginal Bone Changes With Ozone Therapy (ozone-ımplant)
13 de septiembre de 2026 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
Merkez
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Adıyaman, Merkez, Turquía (Türkiye), 02030
- Faculty of Dentistry, Adıyaman University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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.
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Comparador activo: 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.
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Implants were placed using the standard surgical protocol, followed by standard postoperative care, without intraoperative or postoperative ozone application.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Marginal Bone Level Around Dental Implants
Periodo de tiempo: Baseline and 6 months after implant placement
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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.
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Baseline and 6 months after implant placement
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: METİN ÇALIŞIR, PhD, Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de septiembre de 2025
Finalización primaria (Actual)
18 de mayo de 2026
Finalización del estudio (Actual)
18 de mayo de 2026
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de junio de 2026
Publicado por primera vez (Actual)
7 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HRU-25.14.63
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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