- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07760974
Evaluation the Accuracy of Immediate Implant Placement Using SocketFit Static Surgical Guide Versus Conventional Static Surgical Guide in Anterior Esthetic Zone (SocketFit)
11 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
26
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Aliaa s. Kishk, Batchelor
- Telefonnummer: +201015101949
- E-post: Aliaa8271staff@dent.tanta.edu.eg
Studera Kontakt Backup
- Namn: rehab f ghouraba, PHD
- Telefonnummer: +201211512429
- E-post: rehab_ghouraba@dent.tanta.edu.eg
Studieorter
-
-
Gharbia Governorate
-
Tanta, Gharbia Governorate, Egypten, 31773
- Rekrytering
- Periodontology Clinic at Faculty of Dentistry Tanta University
-
Kontakt:
- rehab f ghouraba, PHD
- Telefonnummer: +201211512429
- E-post: rehab_ghouraba@dent.tanta.edu.eg
-
Kontakt:
- Aliaa S Kishk, Batchelor
- Telefonnummer: +201015101949
- E-post: Aliaa8271staff@dent.tanta.edu.eg
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Aktiv 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Coronal deviation
Tidsram: 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.
|
Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
|
apical deviation
Tidsram: 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.
|
Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
|
depth(vertical) deviation
Tidsram: 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.
|
Immediately after implant placement following digital superimposition of the planned and actual implant positions.
|
|
angular deviation
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Aliaa s. Kishk, Batchelor, Tanta University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 augusti 2026
Primärt slutförande (Beräknad)
1 juli 2027
Avslutad studie (Beräknad)
1 juli 2027
Studieregistreringsdatum
Först inskickad
7 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
7 augusti 2026
Första postat (Faktisk)
12 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 3626
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .