- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07828067
Short Versus Standard Dental Implants: Clinical and Biomarker Outcomes
15 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
40
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Kubra Aral
- Numéro de téléphone: 05330578801
- E-mail: drkubraaral@gmail.com
Lieux d'étude
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Malatya, Turquie (Türkiye)
- Inonu University Faculty of Dentistry
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Peri-Implant Crevicular Fluid RANKL Level
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Change in Peri-Implant Probing Depth
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
20 septembre 2026
Achèvement primaire (Estimé)
30 décembre 2026
Achèvement de l'étude (Estimé)
30 décembre 2026
Dates d'inscription aux études
Première soumission
10 septembre 2026
Première soumission répondant aux critères de contrôle qualité
15 septembre 2026
Première publication (Réel)
18 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2026/11007
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
Beginning 6 months and ending 24 months following article publication
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .