- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07760974
Evaluation the Accuracy of Immediate Implant Placement Using SocketFit Static Surgical Guide Versus Conventional Static Surgical Guide in Anterior Esthetic Zone (SocketFit)
11. August 2026 aktualisiert von: Aliaa Saeed Kishk, Tanta University
This study compares two types of surgical guides used during immediate dental implant placement in the upper front teeth.
One guide is a conventional static surgical guide, while the other is a modified SocketFit static surgical guide designed to improve stability after tooth extraction.
The purpose of the study is to determine whether the SocketFit guide improves the accuracy of implant placement.The findings may help improve the precision and predictability of immediate dental implant treatment in the anterior esthetic zone.
Studienübersicht
Status
Rekrutierung
Intervention / Behandlung
Detaillierte Beschreibung
Immediate implant placement in the anterior esthetic zone is a predictable treatment option that reduces treatment time and preserves peri-implant soft and hard tissues.
Static computer-guided surgery has improved the accuracy of implant placement; however, guide stability may be compromised immediately after tooth extraction because of complex morphology and angulation of post-extraction sockets, as well as variations in bone density.These factors can lead to surgical drill displacement, causing the implant to deviate from its intended trajectory.Therefore, The SocketFit static surgical guide incorporates a socket-engaging extension designed to enhance guide seating and stability during osteotomy preparation.
Limited evidence is available regarding the accuracy of this modified guide compared with the conventional tooth-supported static surgical guide.
Therefore, this study aims to evaluate the accuracy of immediate implant placement using the SocketFit static surgical guide versus the conventional static surgical guide in the anterior esthetic zone.
Accuracy will be assessed by comparing the planned and actual implant positions using postoperative Cone Beam Computed Tomography (CBCT) superimposition, evaluating coronal, apical, angular, and depth deviations.
Studientyp
Interventionell
Einschreibung (Geschätzt)
26
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Aliaa s. Kishk, Batchelor
- Telefonnummer: +201015101949
- E-Mail: Aliaa8271staff@dent.tanta.edu.eg
Studieren Sie die Kontaktsicherung
- Name: rehab f ghouraba, PHD
- Telefonnummer: +201211512429
- E-Mail: rehab_ghouraba@dent.tanta.edu.eg
Studienorte
-
-
Gharbia Governorate
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Tanta, Gharbia Governorate, Ägypten, 31773
- Rekrutierung
- Periodontology Clinic at Faculty of Dentistry Tanta University
-
Kontakt:
- rehab f ghouraba, PHD
- Telefonnummer: +201211512429
- E-Mail: rehab_ghouraba@dent.tanta.edu.eg
-
Kontakt:
- Aliaa S Kishk, Batchelor
- Telefonnummer: +201015101949
- E-Mail: Aliaa8271staff@dent.tanta.edu.eg
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Patients in good health with absence of any relevant medical condition that contraindicates dental implant placement e.g. blood coagulation disorder.
- Optimal compliance is evidenced by no missed treatment appointments and a positive attitude toward oral hygiene.
- Extraction socket type I according to Ellian et al criteria with adequate native/apical bone to achieve primary implant stability and intact buccal plate of bone.
- Thick mucosal phenotype.
- Probing depth ≤ 3 mm at mid-buccal aspect of failing tooth.
- Age ranged from 18- 35 years old of both genders.
Exclusion Criteria:
- Patients subjected to irradiation in the head and neck area.
- Bisphosphonate therapy.
- Females who are pregnant or trying to conceive, and nursing mothers.
- Smokers and uncontrolled diabetic patients.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: SocketFit Static Surgical Guide
Participants will undergo immediate implant placement in the anterior esthetic zone using the SocketFit static surgical guide.
The guide incorporates a socket-engaging extension designed to enhance guide stability and drilling accuracy following atraumatic tooth extraction.
Implant placement will be performed according to the planned digital workflow.
|
Participants will undergo immediate implant placement in the anterior esthetic zone using the SocketFit static surgical guide.
The guide incorporates a socket-engaging extension designed to enhance guide stability and drilling accuracy following atraumatic tooth extraction.
Implant placement will be performed according to the planned digital workflow.
|
|
Aktiver Komparator: Conventional Static Surgical Guide
Participants allocated to the control group will undergo immediate implant placement in the anterior esthetic zone using a conventional tooth-supported static surgical guide designed through the standard digital workflow.
Following atraumatic tooth extraction, the guide will be seated on the remaining teeth to direct sequential osteotomy preparation and implant placement according to the preoperative virtual implant plan.
All other surgical procedures, implant system, drilling protocol, and postoperative management will be identical to those used in the experimental group.
|
Participants allocated to the control group will undergo immediate implant placement in the anterior esthetic zone using a conventional tooth-supported static surgical guide designed through the standard digital workflow.
Following atraumatic tooth extraction, the guide will be seated on the remaining teeth to direct sequential osteotomy preparation and implant placement according to the preoperative virtual implant plan.
All other surgical procedures, implant system, drilling protocol, and postoperative management will be identical to those used in the experimental group.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Coronal deviation
Zeitfenster: Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
The linear distance (mm) between the planned and actual implant positions at the coronal platform, measured by digital superimposition of the preoperative implant plan and postoperative Cone Beam Computed Tomography (CBCT) data.
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Immediately after implant placement following digital superimposition of the planned and actual implant positions.
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apical deviation
Zeitfenster: Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
The linear distance (mm) between the planned and actual implant positions at the implant apex, measured using digital superimposition of the preoperative implant plan and postoperative Cone Beam Computed Tomography (CBCT) data.
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Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
|
depth(vertical) deviation
Zeitfenster: Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
The vertical difference (mm) between the planned and actual implant positions along the implant long axis, measured using digital superimposition of the preoperative implant plan and postoperative Cone Beam Computed Tomography (CBCT) data.
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Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
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angular deviation
Zeitfenster: Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
The angular difference (degrees) between the long axes of the planned and actual implant positions, measured using digital superimposition of the preoperative implant plan and postoperative Cone Beam Computed Tomography (CBCT) data.
|
Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Aliaa s. Kishk, Batchelor, Tanta University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. August 2026
Primärer Abschluss (Geschätzt)
1. Juli 2027
Studienabschluss (Geschätzt)
1. Juli 2027
Studienanmeldedaten
Zuerst eingereicht
7. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
7. August 2026
Zuerst gepostet (Tatsächlich)
12. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
11. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 3626
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
No individual participant data (IPD) will be shared.
All personal identifiers, including names and any information that could identify participants, will be removed before data analysis or sharing.
De-identified Cone Beam Computed Tomography (CBCT) images, Stereolithography (STL ) models, and summary outcome data may be used in scientific publications or presentations in accordance with participant consent, ethical approval, and institutional regulations.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .