Evaluation of Fluid Biomarkers Around Implants Exhibiting Early Stage Periimplant Bone Loss
7 de mayo de 2026 actualizado por: Raziye Tugce Can Keles, Pamukkale University
Evaluation of Biomarkers Involved In Bone Metabolism (Remodeling) In Periimplanter Crevicular Fluid of Implants With Early Marginal Bone Loss: A Retrospective Clinical Study
This study aimed to compare biological mediators known to be important in peri-implant diseases in implants with and without early stage marginal bone loss.
A total of 118 implants in 59 patients were designated as test and control groups.
The radiographic and periodontal data of the included implants, along with peri-implant sulcus fluid samples, were evaluated.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study included clinical and radiographic records of patients who received implant treatment in the maxilla and/or mandible between 11/2021 and 9/2024.
Patients were divided into test and control groups based on the presence/absence of EMBL after prosthetic loading.
Periodontal clinical measurements were recorded and peri-implant sulcus fluid (PISF) samples were collected.
Sclerostin, calprotectin, type I collagen cross-linked N-telopeptide (NTx), matrix metalloproteinase (MMP)-8, and MMP-9 levels were analyzed using ELISA.
Group comparisons were performed with the statistical analyses.
Tipo de estudio
De observación
Inscripción (Actual)
59
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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Denizli, Turquía (Türkiye), 20160
- Pamukkale University, Faculty of Dentistry, Periodontology
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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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
Patients who received implant treatment at the Department of Periodontology, Pamukkale University Faculty of Dentistry.
Descripción
Inclusion Criteria:
- Presence of 1 mm or more of radiographic marginal bone loss within the first 3 months after implant placement
- Availability of radiographic documentation
- Availability of demographic data, surgical records, and data related to the implant used
- Physical condition classified as Class I and II according to the American Society of Anesthesiologists (ASA) classification
- Patients with no smoking history in the last 10 years
- Fixed implant-supported restorations
- Screw-retained implants
Exclusion Criteria:
- Patients receiving and/or maintaining implant treatment at centers other than the Department of Periodontology, Pamukkale University Faculty of Dentistry
- Patients with incomplete or unreachable files or radiographic documentation
- Patients with a known systemic disease/condition that alters their physical condition or bone metabolism
- Severe bruxism cases
- Pregnant and breastfeeding patients
- Patients with incomplete implant-supported prosthesis
- Areas grafted during or before implant surgery
- Removable implant-supported restorations
- Cement-retained implants
- Patients undergoing peri-implantitis treatment
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Test
Presence of marginal bone loss of 1 mm or more within the first 3 months after implant placement
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To evaluate biomarkers associated with peri-implant bone loss, periopaper was placed in the peri-implant pocket and absorbed with sulcus fluid.
Parallel cone technique was used during periapical imaging to accurately measure peri-implant bone loss.
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Control
Presence of less than 1 mm of marginal bone loss within the first 3 months after implant placement
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To evaluate biomarkers associated with peri-implant bone loss, periopaper was placed in the peri-implant pocket and absorbed with sulcus fluid.
Parallel cone technique was used during periapical imaging to accurately measure peri-implant bone loss.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Calprotectin levels in peri-implant crevicular fluid
Periodo de tiempo: 6-8 week after prosthetic treatment
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After collecting peri-implant sulcus fluid using the paper strip method, calprotectin levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
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6-8 week after prosthetic treatment
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Sclerostin levels in peri-implant crevicular fluid
Periodo de tiempo: 6-8 week after prosthetic treatment
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After collecting peri-implant sulcus fluid using the paper strip method, sclerostin levels in the peri-implant sulcus region were determined using the ELISA method and recorded in pg/ml.
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6-8 week after prosthetic treatment
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NTx levels in peri-implant crevicular fluid
Periodo de tiempo: 6-8 week after prosthetic treatment
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After collecting peri-implant sulcus fluid using the paper strip method, NTx levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
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6-8 week after prosthetic treatment
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MMP-8 levels in peri-implant crevicular fluid
Periodo de tiempo: 6-8 week after prosthetic treatment
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After collecting peri-implant sulcus fluid using the paper strip method, MMP-8 levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
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6-8 week after prosthetic treatment
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MMP-9 levels in peri-implant crevicular fluid
Periodo de tiempo: 6-8 week after prosthetic treatment
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After collecting peri-implant sulcus fluid using the paper strip method, MMP-9 levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.
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6-8 week after prosthetic treatment
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Radiographic detecting of Peri-implant marginal bone loss
Periodo de tiempo: Baseline, 3 months
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The amount of marginal bone loss was determined by comparing the periapical radiograph taken on the day the implants were placed with the radiograph taken at 3 months.
Measurements of digital radiographic images were performed using computer software.
Then, study groups were determined according to the presence or absence of peri-implant marginal bone loss.
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Baseline, 3 months
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Modified Bleeding İndex
Periodo de tiempo: During the same session as the peri-implant fluid collection procedure
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This assessment was performed based on the bleeding response following gentle probing with a plastic probe in the four regions of each implant (mesial, distal, palatal/lingual, and buccal).
The severity of bleeding observed within approximately 10-30 seconds after probing was scored and recorded.
The scoring system was graded as follows: 0: no bleeding, 1: bleeding at a single point, 2: bleeding at several points or in a linear pattern, 3: heavy bleeding following probing.
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During the same session as the peri-implant fluid collection procedure
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Peri-implant pocket depth
Periodo de tiempo: During the same session as the peri-implant fluid collection procedure
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A plastic periodontal probe was used to determine peri-implant pocket depth.
Measurements were taken by using the probe, supported by its own weight, parallel to the long axis of the tooth.
Pocket depth was measured at 6 sites (mesio-buccal, buccal, disto-buccal, mesio-palatal/lingual, palatal/lingual, disto-palatal/lingual) for each implant included in the study and recorded in millimeters (mm).
The pocket depth value for each dental implant was obtained by calculating the average of the 6 measured values.
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During the same session as the peri-implant fluid collection procedure
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Gingival İndex
Periodo de tiempo: During the same session as the peri-implant fluid collection procedure
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The mesial, distal, buccal, and lingual/palatal surfaces of each tooth/implant were evaluated separately, and the average of the scores obtained was recorded as the gingival index value for that tooth/implant.
Scoring during the evaluation was performed as follows: 0 = normal gingiva, 1 = mild inflammation (color change, mild edema, no bleeding on probing), 2 = moderate inflammation (redness, edema, bleeding on probing), 3 = severe inflammation (marked redness, edema, ulceration, spontaneous bleeding).
Subsequently, all values were summed and divided by the total number of teeth and implants to record the gingival index score.
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During the same session as the peri-implant fluid collection procedure
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Modified Plaque İndex
Periodo de tiempo: During the same session as the peri-implant fluid collection procedure
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The mesial, distal, buccal, and lingual/palatal surfaces around the teeth/implants were examined, and the average of the scores obtained for each surface was recorded as the plaque index for that tooth/implant.
The scoring criteria were as follows: 0 = no plaque, 1 = plaque detectable only with a probe, 2 = soft plaque accumulation visible to the naked eye, 3 = the tooth surface covered with a distinct plaque layer.
Subsequently, all values were summed and divided by the total number of teeth and implants to record the modified plaque index score.
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During the same session as the peri-implant fluid collection procedure
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Peri-implant mucosal recession
Periodo de tiempo: During the same session as the peri-implant fluid collection procedure
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The abutment-implant interface was designated as the reference point for determining the extent of peri-implant mucosal recession, and the distance between the reference point and the free gingival margin was measured using a periodontal probe.
Mucosal recession was recorded in four regions (mesio-buccal, mid-buccal, disto-buccal, mid-lingual/palatal) for each implant included in the study.
The recession value for each implant was obtained by calculating the average of the four measured values.
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During the same session as the peri-implant fluid collection procedure
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Raziye Tugce Can Keles, R.A., Pamukkale University Faculty of Dentistry, Department of Periodontology
- Director de estudio: Gizem Torumtay Cin, Assoc. Prof., Pamukkale University Faculty of Dentistry, Department of Periodontology
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)
6 de marzo de 2025
Finalización primaria (Actual)
6 de septiembre de 2025
Finalización del estudio (Actual)
6 de septiembre de 2025
Fechas de registro del estudio
Enviado por primera vez
3 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de mayo de 2026
Publicado por primera vez (Actual)
13 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- E-60116787-020-604271
- 2025DİŞF001 (Otro identificador: Office of Scientific Research Projects of Pamukkale University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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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