Customized Healing Caps in Immediate Implants – A Randomized Controlled Study
Résumé de l'étude
The loss of a tooth in the visible aesthetic area affects the well-being and quality of life of many patients. Immediate implants are an established treatment method that can restore function and aesthetics in the shortest time possible. During the healing phase, so-called customized healing caps are used. In this study, we compare two different approaches to the production of customized healing caps: A) Postoperative production: The healing cap is manufactured after implantation based on an intraoral scan, which takes about 4 hours. B) Preoperative production: The healing cap is created before the operation based on a virtual treatment plan and is available immediately for the operation. We want to find out whether the preoperative production of healing caps is as effective as the postoperative method, particularly regarding the stability of the soft tissues and the aesthetic outcome.
(BASEC)
Intervention étudiée
Tooth loss significantly affects both well-being and masticatory function. Dental implants are currently the treatment of choice to replace missing teeth with fixed dental prostheses. Depending on patient-related factors, a dental implant can be placed immediately after tooth extraction (immediate implantation). To counteract bone loss during wound healing, bone replacement materials are introduced into the tooth socket around the implant as part of the immediate implantation. To stabilize these bone replacement materials around the implant and ensure closure to the oral cavity, customized healing caps are manufactured. These caps precisely follow the contour of the gingival margin of the extracted tooth and seal the tooth socket. Until now, such healing caps have been produced based on the final implant position, which is captured during the operation using an intraoral scan. The production takes about 4-5 hours before they can be placed on the implant. However, thanks to virtual treatment planning and modern computer-assisted surgical procedures, it is possible to plan and implement the implant position preoperatively with high accuracy. This technology allows for the customized healing caps to be produced before the operation and to be placed on the implant at the end of the procedure, thereby saving valuable treatment time. After implantation, a healing phase of about two months occurs, during which the implant and the bone replacement material are integrated stably into the tissue. Subsequently, the final dental crown for the implant can be manufactured and placed. The tooth extraction and subsequent dental implantation take place at the Clinic for Oral Surgery and Stomatology, while the production and provision of the customized healing cap occur at the Clinic for Reconstructive Dentistry and Gerodontology. Further provision of the dental implant with a crown is carried out by your referring dentist. Additional study-related follow-up examinations take place at the zmk Bern.
(BASEC)
Maladie en cours d'investigation
Tooth loss
(BASEC)
- Intended implant-supported replacement of a non-salvageable tooth - Age > 20 years - Anatomical prerequisites corresponding to the technique of immediate implantation (BASEC)
Critères d'exclusion
- Any physical or mental illness that could impair the ability to maintain adequate oral hygiene or to provide written consent after being informed and to ensure compliance with the study protocol. - Any condition that could impair wound healing or represent a contraindication for implant surgery, such as uncontrolled diabetes or conditions requiring immunosuppression, radiation therapy, chemotherapy, frequent use of antibiotics, or anti-resorptive medications like bisphosphonates. - Pregnancy or the intention to become pregnant. (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
Klinik für Oralchirurgie und Stomatologie, Universität Bern
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. Clemens Raabe, MAS
031 684 06 10
clemens.raabe@clutterunibe.chKlinik für Oralchirurgie und Stomatologie, Universität Bern
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
23.04.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Pre- versus postoperative individualized healing abutment fabrication in immediate implant placement - a randomized controlled trial (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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