- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07828067
Short Versus Standard Dental Implants: Clinical and Biomarker Outcomes
15. september 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Antatt)
40
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Kubra Aral
- Telefonnummer: 05330578801
- E-post: drkubraaral@gmail.com
Studiesteder
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Malatya, Tyrkia (Türkiye)
- Inonu University Faculty of Dentistry
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
20. september 2026
Primær fullføring (Antatt)
30. desember 2026
Studiet fullført (Antatt)
30. desember 2026
Datoer for studieregistrering
Først innsendt
10. september 2026
Først innsendt som oppfylte QC-kriteriene
15. september 2026
Først lagt ut (Faktiske)
18. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2026/11007
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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
Tilgangskriterier for IPD-deling
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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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