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Evaluation of the Accuracy of Root Guided Immediate Implant Placement at Maxillary- Molar Region

14 juin 2026 mis à jour par: Abeer Rizk Zakaria Nasef, Tanta University
Twenty patients with non restorable maxillary molar that indicate to immediate implant will be included in this study. The patients will be divided randomly (10 patients each group). Group I(study),immediate implant placement will be done using root guide technique.Group II(control),immediate implant placement will be done using surgical guide technique.The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department,Faculty of Dentistry, Tanta University.The patients will be evaluated clinically to evaluate healing and radio graphically using cone beam CT (CBCT) scan to identify bone density post operative and after 6 months.

Aperçu de l'étude

Description détaillée

Purpose: This study aimed to evaluate the accuracy of the root guide technique in comparison to the surgical guide technique for immediate implant placement in the maxillary- molar region radiographically and clinically.

Materials & Methods:Twenty patients with non restorable maxillary molar will be included in this study. The patients will be divided randomly (10 patients each group). Group I,immediate implant placement will be done using root guide technique.Group II,immediate implant placement will be done using surgical guide technique.The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department,Faculty of Dentistry, Tanta University.The patients will be evaluated clinically to evaluate healing and radio graphically using cone beam CT (CBCT) scan to identify bone density post operative and after 6 months.

Preoperative evaluation: The patients will be evaluated clinically and radiographically using Cone beam CT(CBCT) scan , before implant placement for assessment of the anatomy of inter-radicular septum and tooth roots ,periapical pathology , bone density and approximation of vital structures , then we will make virtual planning to future implant position.

  • fabrication of surgical guide stent( tooth born ): will be done for Group II, Conventional impression will be taken with irreversible hydrocolloid to make a diagnostic cast.

    • The cast will be scanned with a laboratory scanner.
    • -The scanned data of the cast will exported as a standard tessellation language (STL) file, while the CBCT image will saved as Digital Imaging and Communications in Medicine (DICOM) data 26 .
    • -Design of the surgical guide proceeded with superimposition of the STL file to the CBCT data through a software [Blue Sky software].⃰
    • -Completion of virtual implant treatment planning with proper adjustment, the adequate position of the implant will planned with the creation of open sleeve.
    • -Selection and fabrication of surgical guide based on the computed tomography model and print it by Creality LD006 ⃰⃰

Surgical procedure:

Stage 1:

Group I:

All patients will undergo the surgery under local anesthesia. We will do coronctomy to the level of free gingiva and separation of the roots with surgical fissure bur ,drilling the implant site according to manufacture's proptocl will be done with roots intact in their sockets within the inter-radicular bone. Clinically visible roots will be extracted by using periotomes .Following extraction, the socket will be debrided to remove any reminants and the socket and osteotomy will be irrigated by sterile normal saline . The implant will be inserted into the site following manufacture's protocol.

GroupII All patients will undergo the surgery under local anesthesia. Surgical separation of the roots will be done by surgical fissure bur , separated roots will be extracted by periotomes , the socket will be debrided to remove any reminants and irrigated by sterile normal saline. Following extraction, drilling the implant site will be done through the surgical guide (tooth supported surgical guide) according to manufacturer's protocol, implant will be inserted into the site following manufactures protocol.

- After insertion of the implant in both groups: the primary stability will be measured by Osstell device (resonance frequency analyzer, (RFA) is a device that uses resonance frequency analysis to measure implant stability quotient (ISQ)) , then we will fill the gap between the implant and walls of the socket by bone graft graft(xenogeneic bone graft) and PRF (platelets- rich fibrin) around the implant into the socket , finally custom mad haling abutment will b made.

Postoperative evaluation: The patients will be evaluated clinically regarding healing, presence of inflammation,and swelling each week at the first month then after 3 months and 6 months and assess pain, by Visual Analog Scale weekly during the first month (at days 1,7, and14). . Implant stability will be assessed at the time of implant insertion and 6 months after the operation.

Radiographically,During the follow-up period a CBCT will be taken immediately postoperative and 6 months after the operation.

Immediate CBCT was to compare the actual position of the implant with the preoperative virtual planning of the implant position by superimposition of preoperative and postoperative CBCT. Three deviation parameters between each planned and placed implant were measured :

  • Horizontal deviation at coronal side of the implant.
  • Horizontal deviation at apex of the implant
  • Angular deviation. All measurements were performed using Mimics Innovation Suite 19tm software.

Stage II( crest module uncoverage and healing abutment installation).:

After 6 months of consolidation and osseointegration period, CBCT was done to assess the oseteointegration . A surgical re-entry procedure performed to allow access to the crest module of the fixture.

Prior to the start of surgery, the patient rinsed his mouth with betadine for 1 min. The oral cavity was scrubbed with betadine (povidine iodine 2.5%) antiseptic solution.

Under local anesthesia ,custom made healing abutment was removed to exposure the implant . Smart peg was installed at the fixture level to assess secondary implant stability before loading.A healing abutment selected according to the soft tissue thickness installed until gingival collar becomes adequate around the implant.

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Type d'étude

Interventionnel

Inscription (Estimé)

20

Phase

  • N'est pas applicable

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.

Lieux d'étude

      • Tanta, Egypte, 3111
        • faculty of dentistry, Tanta university

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

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • • Patients with non-restorable maxillary molars.

    • Age of patients above 18 years old.
    • Good oral hygiene.
    • Healthy covering keratinized oral mucosa.

Exclusion Criteria:

  • • Patients with systemic disease that may affect bone healing.

    • Periapical pathosis.
    • Heavy smoker patients(>14 cigarettes per day).

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

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Root guide technique
ten patients with non restorable maxillary molar which indicated to immediate implant were treated by using root guide technique for placement of immediate implant . Drilling the implant site according to protocol of manufacture was done with roots intact in their sockets within the inter-radicular bone
group I ten patients with non restorable maxillary molar will be undergo placement of immediate implant by using root guide for drilling of the ostoetomy site.
Expérimental: surgical guide technique
ten patients with non restorable maxillary molar which indicated to immediate implant were treated by using surgical guide.Drilling the implant site according to protocol of manufacture was done through the surgical guide after extraction of roots.
group II ten patients with non restorable maxillary molar will be undergo placement of immediate implant by using surgical guide for drilling of the ostoetomy site.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
degree of pain
Délai: one-two weeks
degree of pain evaluated clinically in both groups using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
one-two weeks
soft tissue healing
Délai: one week
soft tissue healing evaluated clinically in both groups presence of dehiscence and exposure of bone or not
one week
infection
Délai: one week-one month
infection evaluated clinically in both groups presence of signs of infection or not
one week-one month
density of bone
Délai: six months]
density of bone calculated radiographically in both groups CBCT
six months]

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
inflammation
Délai: one week
inflammation clinically in both groups 0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation
one week

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Abeer R Nasef, doctor, Tanta Universality

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 (Réel)

22 mars 2025

Achèvement primaire (Estimé)

30 juin 2026

Achèvement de l'étude (Estimé)

10 juillet 2026

Dates d'inscription aux études

Première soumission

14 juin 2026

Première soumission répondant aux critères de contrôle qualité

14 juin 2026

Première publication (Réel)

18 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 2243

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 .

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