- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07828067
Short Versus Standard Dental Implants: Clinical and Biomarker Outcomes
15. september 2026 opdateret af: Kubra Aral, Inonu University
Comparison of Peri-Implant Tissue Health and Biomarker Outcomes Between Short and Standard Dental Implants: A Prospective Study
This study compares two types of dental implants, short implants (6 millimeters or less in length) and standard implants (longer than 8 millimeters), to evaluate their effect on the health of the gum and bone tissue surrounding the implant.
Approximately 40 patients receiving a total of 80 dental implants will be followed.
Researchers will assess clinical signs of gum health around the implants, measure specific protein levels (biomarkers) in the fluid surrounding the implants associated with gum disease.
The goal of this study is to determine whether implant length affects the risk of inflammation or infection around dental implants, which may help guide treatment decisions in the future.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
This is a prospective study enrolling approximately 40 patients who will receive a total of 80 dental implants, categorized as short (≤6 mm) or standard (>8 mm) in length.
Peri-implant crevicular fluid (PICF) samples will be collected at baseline from all patients.
In patients who develop peri-implant mucositis, an additional PICF sample will be collected at 1 and 3 months.
PICF samples will be analyzed by ELISA for RANKL, OPG, cathepsin-K, and cytokine levels.
Implant diameter and length will be recorded for each patient.
Clinical parameters of peri-implant tissue health will also be assessed at each visit.
The study aims to compare biochemical and clinical outcomes between short and standard implants to determine whether implant length influences peri-implant tissue health.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
40
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Kubra Aral
- Telefonnummer: 05330578801
- E-mail: drkubraaral@gmail.com
Studiesteder
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Malatya, Tyrkiet (Türkiye)
- Inonu University Faculty of Dentistry
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adult patients presenting to the Department of Periodontology, Faculty of Dentistry, Inonu University, for routine dental check-up, who have at least one short (≤6 mm) and/or standard (>8 mm) dental implant in function for at least 2 years.
Beskrivelse
Inclusion Criteria:
- Systemically healthy adults aged 18-70 years.
- Presence of at least one short (≤6 mm) and/or standard (>8 mm) dental implant in function for at least 2 years.
- Patients presenting to the Department of Periodontology, Faculty of Dentistry, Inonu University, for routine dental examination.
- For the peri-implant health group: absence of clinical signs of inflammation (redness, edema, or suppuration), absence of bleeding on probing (BOP), probing pocket depth (PPD) ≤5 mm, full-mouth BOP <10%, no radiographic evidence of pathological peri-implant bone loss, and no clinical implant mobility.
- For the peri-implant mucositis group: presence of clinical signs of inflammation (redness and/or edema) without suppuration, presence of bleeding on probing (BOP), probing pocket depth (PPD) ≤5 mm, full-mouth BOP >10%, no radiographic evidence of pathological peri-implant bone loss, and no clinical implant mobility.
Exclusion Criteria:
- Age younger than 18 years or older than 70 years.
- Presence of any systemic disease.
- Immune system disorders or use of immunosuppressive medications.
- Requirement for antibiotic prophylaxis before dental procedures.
- Bisphosphonate therapy for osteoporosis.
- Pregnancy or lactation.
- Smoking.
- Alcohol consumption.
- Antibiotic treatment within the previous 6 months.
- Continuous use of systemic medications.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Short implant group
Patients receiving dental implants with a length of 6 mm or less.
Peri-implant crevicular fluid (PICF) samples will be collected to assess RANKL, OPG, and cathepsin-K levels, along with clinical peri-implant tissue health parameters
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Standard Implant Group
Patients receiving dental implants with a length greater than 8 mm.
Peri-implant crevicular fluid (PICF) samples will be collected to assess RANKL, OPG, and cathepsin-K levels, along with clinical peri-implant tissue health parameters.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Peri-Implant Crevicular Fluid RANKL Level
Tidsramme: Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Receptor activator of nuclear factor kappa-B ligand (RANKL) levels in peri-implant crevicular fluid (PICF) will be measured using enzyme-linked immunosorbent assay (ELISA) and compared between short and standard implant groups.
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Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Change in Peri-Implant Crevicular Fluid OPG Level
Tidsramme: Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Osteoprotegerin (OPG) levels in peri-implant crevicular fluid (PICF) will be measured using enzyme-linked immunosorbent assay (ELISA) and compared between short and standard implant groups.
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Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Change in Peri-Implant Crevicular Fluid Cathepsin K Level
Tidsramme: Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Cathepsin K levels in peri-implant crevicular fluid (PICF) will be measured using enzyme-linked immunosorbent assay (ELISA) and compared between short and standard implant groups.
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Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Peri-Implant Probing Depth
Tidsramme: Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Peri-implant probing depth (PPD) will be measured in millimeters using a periodontal probe at six sites around each implant and compared between short and standard implant groups.
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Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Change in Peri-Implant Bleeding on Probing
Tidsramme: Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Bleeding on probing (BOP) will be assessed following gentle probing around each implant and recorded as the percentage of sites exhibiting bleeding.
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Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Change in Peri-Implant Plaque Index
Tidsramme: Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Peri-implant plaque accumulation will be evaluated using the Plaque Index (PI) and compared between short and standard implant groups.
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Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Change in Gingival Index
Tidsramme: Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Peri-implant soft tissue inflammation will be evaluated using the Gingival Index (mGI) and compared between short and standard implant groups.
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Baseline; 1 and 3 months after non-surgical peri-implant therapy in participants who develop peri-implant mucositis.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
- Guarnieri R, Di Nardo D, Gaimari G, Miccoli G, Testarelli L. Short vs. Standard Laser-Microgrooved Implants Supporting Single and Splinted Crowns: A Prospective Study with 3 Years Follow-Up. J Prosthodont. 2019 Feb;28(2):e771-e779. doi: 10.1111/jopr.12959. Epub 2018 Aug 31.
- Karci BL, Oncu E. Comparison of Osteoimmunological and Microbiological Parameters of Extra Short and Longer Implants Loaded in the Posterior Mandible: A Split Mouth Randomized Clinical Study. Acta Stomatol Croat. 2021 Sep;55(3):238-247. doi: 10.15644/asc55/3/1.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
20. september 2026
Primær færdiggørelse (Anslået)
30. december 2026
Studieafslutning (Anslået)
30. december 2026
Datoer for studieregistrering
Først indsendt
10. september 2026
Først indsendt, der opfyldte QC-kriterier
15. september 2026
Først opslået (Faktiske)
18. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2026/11007
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data will be shared, including participant age, sex, and clinical periodontal parameters (plaque index, gingival index, probing depth, clinical attachment level, bleeding on probing).
Participants will be identified only by coded/numbered case report forms; no names, gender identity beyond biological sex, or other identifying information will be shared.
IPD-delingstidsramme
Beginning 6 months and ending 24 months following article publication
IPD-delingsadgangskriterier
Data will be made available to researchers who provide a methodologically sound proposal, subject to approval by the corresponding author, for the purpose of achieving the aims outlined in the approved proposal.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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