Evaluation of Fluid Biomarkers Around Implants Exhibiting Early Stage Periimplant Bone Loss
7 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
59
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Denizli, Turkije (Türkiye), 20160
- Pamukkale University, Faculty of Dentistry, Periodontology
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Patients who received implant treatment at the Department of Periodontology, Pamukkale University Faculty of Dentistry.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Calprotectin levels in peri-implant crevicular fluid
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Radiographic detecting of Peri-implant marginal bone loss
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Raziye Tugce Can Keles, R.A., Pamukkale University Faculty of Dentistry, Department of Periodontology
- Studie directeur: Gizem Torumtay Cin, Assoc. Prof., Pamukkale University Faculty of Dentistry, Department of Periodontology
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
6 maart 2025
Primaire voltooiing (Werkelijk)
6 september 2025
Studie voltooiing (Werkelijk)
6 september 2025
Studieregistratiedata
Eerst ingediend
3 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
7 mei 2026
Eerst geplaatst (Werkelijk)
13 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
7 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- E-60116787-020-604271
- 2025DİŞF001 (Andere identificatie: Office of Scientific Research Projects of Pamukkale University)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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