Cover Screw vs Healing Abutment on Osseointegration
EFFECTS OF COVER SCREW AND HEALING ABUTMENT ON EARLY IMPLANT STABILITY: A RANDOMIZED CONTROLLED CLINICAL TRIAL
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Merkez
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Adıyaman, Merkez, Türkei (türkiye), 02030
- Faculty of Dentistry, Adıyaman University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Implant Stability Quotient (ISQ)
Zeitfenster: Baseline (implant placement) to 3 months after implant placement
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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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: METİN çalışır, Prof.Dr., Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- HRU-25.04.15
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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