Cover Screw vs Healing Abutment on Osseointegration
EFFECTS OF COVER SCREW AND HEALING ABUTMENT ON EARLY IMPLANT STABILITY: A RANDOMIZED CONTROLLED CLINICAL TRIAL
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This prospective randomized split-mouth controlled clinical trial evaluates the effects of cover screw placement and healing abutment placement on early implant stability and osseointegration. Systemically healthy patients requiring at least two dental implants will be enrolled. Using a split-mouth design, each participant will receive both interventions, with one implant randomly allocated to receive a cover screw (two-stage protocol) and the contralateral implant to receive a healing abutment (one-stage protocol).
Implant stability will be evaluated by insertion torque and resonance frequency analysis (RFA). Implant Stability Quotient (ISQ) values will be recorded at implant placement and at the 3-month follow-up. The primary objective is to compare changes in implant stability (ΔISQ) between the two treatment protocols. Secondary outcomes include implant survival, peri-implant soft tissue healing, and postoperative complications.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Merkez
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Adıyaman, Merkez, Turquie (Türkiye), 02030
- Faculty of Dentistry, Adıyaman University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged ≥18 years. American Society of Anesthesiologists (ASA) physical status I or II. Able and willing to comply with the study protocol and follow-up schedule. Required at least two dental implants in contralateral or symmetrical edentulous sites.
Implant sites free of active infection or acute periodontal disease. Adequate oral hygiene. Sufficient bone volume for placement of a standard-diameter implant with at least 1.5 mm of surrounding peri-implant bone.
Keratinized mucosal width ≥2 mm. Soft tissue thickness ≥2 mm. Written informed consent provided.
Exclusion Criteria:
- Systemic diseases or medical conditions contraindicating implant surgery. Uncontrolled diabetes mellitus (HbA1c >10%). Current intravenous antiresorptive therapy. History of head and neck radiotherapy. Immunosuppressive therapy. Active malignancy. Uncontrolled hypertension. Advanced hepatic or renal insufficiency. Pregnancy. Poor oral hygiene. Active oral infection. Requirement for bone augmentation before implant placement. Inadequate bone volume. Unfavorable peri-implant soft tissue phenotype. Primary implant stability <20 Ncm at implant placement.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Healing Abutment
Dental implants were restored with a healing abutment at the time of implant placement using a one-stage surgical protocol.
Implant stability and osseointegration were evaluated during the follow-up period.
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A healing abutment was connected to the dental implant immediately after implant placement using a one-stage surgical protocol.
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Comparateur actif: Cover Screw
Dental implants were restored with a cover screw at the time of implant placement using a conventional two-stage surgical protocol.
Implant stability and osseointegration were evaluated during the follow-up period.
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A cover screw was connected to the dental implant immediately after implant placement using a conventional two-stage surgical protocol.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Implant Stability Quotient (ISQ)
Délai: Baseline (implant placement) to 3 months after implant placement
|
Implant stability was assessed using resonance frequency analysis (RFA).
Changes in Implant Stability Quotient (ISQ) values from implant placement to the 3-month follow-up were compared between the healing abutment and cover screw groups.
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Baseline (implant placement) to 3 months after implant placement
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: METİN çalışır, Prof.Dr., Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- HRU-25.04.15
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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