Customized Healing Caps in Immediate Implants – A Randomized Controlled Study
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
- 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)
Trial sites
Bern
(BASEC)
Sponsor
Klinik für Oralchirurgie und Stomatologie, Universität Bern
(BASEC)
Contact
Contact Person Switzerland
Dr. Clemens Raabe, MAS
031 684 06 10
clemens.raabe@clutterunibe.chKlinik für Oralchirurgie und Stomatologie, Universität Bern
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
23.04.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Pre- versus postoperative individualized healing abutment fabrication in immediate implant placement - a randomized controlled trial (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available