Evaluation of Fluid Biomarkers Around Implants Exhibiting Early Stage Periimplant Bone Loss
7 maja 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
59
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
-
Denizli, Turcja (Türkiye), 20160
- Pamukkale University, Faculty of Dentistry, Periodontology
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Patients who received implant treatment at the Department of Periodontology, Pamukkale University Faculty of Dentistry.
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Test
Presence of marginal bone loss of 1 mm or more within the first 3 months after implant placement
|
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.
|
|
Control
Presence of less than 1 mm of marginal bone loss within the first 3 months after implant placement
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Calprotectin levels in peri-implant crevicular fluid
Ramy czasowe: 6-8 week after prosthetic treatment
|
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.
|
6-8 week after prosthetic treatment
|
|
Sclerostin levels in peri-implant crevicular fluid
Ramy czasowe: 6-8 week after prosthetic treatment
|
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.
|
6-8 week after prosthetic treatment
|
|
NTx levels in peri-implant crevicular fluid
Ramy czasowe: 6-8 week after prosthetic treatment
|
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.
|
6-8 week after prosthetic treatment
|
|
MMP-8 levels in peri-implant crevicular fluid
Ramy czasowe: 6-8 week after prosthetic treatment
|
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.
|
6-8 week after prosthetic treatment
|
|
MMP-9 levels in peri-implant crevicular fluid
Ramy czasowe: 6-8 week after prosthetic treatment
|
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.
|
6-8 week after prosthetic treatment
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Radiographic detecting of Peri-implant marginal bone loss
Ramy czasowe: Baseline, 3 months
|
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.
|
Baseline, 3 months
|
|
Modified Bleeding İndex
Ramy czasowe: During the same session as the peri-implant fluid collection procedure
|
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.
|
During the same session as the peri-implant fluid collection procedure
|
|
Peri-implant pocket depth
Ramy czasowe: During the same session as the peri-implant fluid collection procedure
|
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.
|
During the same session as the peri-implant fluid collection procedure
|
|
Gingival İndex
Ramy czasowe: During the same session as the peri-implant fluid collection procedure
|
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.
|
During the same session as the peri-implant fluid collection procedure
|
|
Modified Plaque İndex
Ramy czasowe: During the same session as the peri-implant fluid collection procedure
|
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.
|
During the same session as the peri-implant fluid collection procedure
|
|
Peri-implant mucosal recession
Ramy czasowe: During the same session as the peri-implant fluid collection procedure
|
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.
|
During the same session as the peri-implant fluid collection procedure
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Raziye Tugce Can Keles, R.A., Pamukkale University Faculty of Dentistry, Department of Periodontology
- Dyrektor Studium: Gizem Torumtay Cin, Assoc. Prof., Pamukkale University Faculty of Dentistry, Department of Periodontology
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
6 marca 2025
Zakończenie podstawowe (Rzeczywisty)
6 września 2025
Ukończenie studiów (Rzeczywisty)
6 września 2025
Daty rejestracji na studia
Pierwszy przesłany
3 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
7 maja 2026
Pierwszy wysłany (Rzeczywisty)
13 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
13 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
7 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- E-60116787-020-604271
- 2025DİŞF001 (Inny identyfikator: Office of Scientific Research Projects of Pamukkale University)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Utrata kości brzeżnej
-
Mansoura UniversityRekrutacyjnyBone Anchored Miniscrew Assisted Rapid Palatal ExpansionEgipt
-
Xinhua Hospital, Shanghai Jiao Tong University...NieznanyGenu Valgum lub Varum | Wzrost; Aresztowany, Bone | Zatrzymanie nasadowe, podudzie