NCT05409287

Immediate Loading in Single Tooth Implants

Influence of the Implant Loading Protocol on Implant Survival in Early Placed Single-tooth Implants in Mandibular Posterior Sites Using Computer-assisted Implant Surgery: A Randomized Clinical Trial (RCT)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Bern · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The planned study is designed to provide evidence for the application of early implant placement with partial bone-healing and either an immediate or an early restoration/ loading protocol. Materials and methods The study will be conducted according to the recommendations published as the CONSORT statement and respecting the intention to treat principle. Participants will be enrolled if they present with a mandibular first molar that has to be extracted, and require implant treatment for replacement of the molar. Ridge preservation using a well-documented xenogeneic bone substitute will be done following the extraction. After 12 weeks of healing, a cone-beam computed tomography (CBCT) and a digital intraoral scan will be taken, followed by digital planning of the implant position and the additive construction of a surgical drill guide by means of rapid prototyping using a 3-D printer. Afterwards, the participants will be randomized into the two study groups: Group A (immediate loading): A screw-retained PMMA implant provisional bonded to a titanium base will be fabricated subtractively by computer aided design/ computer aided manufacturing (CAD/CAM), based on the data of the digitally planned implant position. Group B (early loading): No further preparation has to be done. Before finishing 16 weeks post-extraction, implants (Straumann Standard Implant RN, TiZr, minimum length: 10mm, minimum diameter 4.1mm) will be placed in both study groups using sCAIS. During surgery, the surgeon will not know if the participant was allocated to Group A or Group B. Directly after surgery, digital intraoral scans will be obtained, to record the final implant position. Afterwards, either the prepared implant provisional (Group A; immediate loading) or a healing cap (Group B, early loading) will be inserted into the implant. 4 weeks after implant placement the participants in Group B will receive a loaded, screw-retained implant provisional, based on the data of the post-surgery scan. 6-months after implant placement participants will receive final screw-retained single implant crowns. The study end will be a final follow-up visit after 12 months. Participants will be invited for further follow-up visits up to 5 years. (not part of the present proposal) Implant survival/ success will be evaluated according to the criteria described by Buser et al. All secondary outcomes will be assessed by validated indices and instruments.

Detailed description

The planned study is designed to provide evidence for the application of early implant placement with partial bone-healing and either an immediate or an early restoration/ loading protocol. Materials and methods The study will be conducted according to the recommendations published as the CONSORT statement and respecting the intention to treat principle. Participants will be enrolled if they present with a mandibular first molar that has to be extracted, and require implant treatment for replacement of the molar. Ridge preservation using a well-documented xenogeneic bone substitute will be done following the extraction. After 12 weeks of healing, a cone-beam computed tomography (CBCT) and a digital intraoral scan will be taken, followed by digital planning of the implant position and the additive construction of a surgical drill guide by means of rapid prototyping using a 3-D printer. Afterwards, the participants will be randomized into the two study groups: Group A (immediate loading): A screw-retained PMMA implant provisional bonded to a titanium base will be fabricated subtractively by computer aided design/ computer aided manufacturing (CAD/CAM), based on the data of the digitally planned implant position. Group B (early loading): No further preparation has to be done. Before finishing 16 weeks post-extraction, implants (Straumann Standard Implant RN, TiZr, minimum length: 10mm, minimum diameter 4.1mm) will be placed in both study groups using sCAIS. During surgery, the surgeon will not know if the participant was allocated to Group A or Group B. Directly after surgery, digital intraoral scans will be obtained, to record the final implant position. Afterwards, either the prepared implant provisional (Group A; immediate loading) or a healing cap (Group B, early loading) will be inserted into the implant. 4 weeks after implant placement the participants in Group B will receive a loaded, screw-retained implant provisional, based on the data of the post-surgery scan. 6-months after implant placement participants will receive final screw-retained single implant crowns. The study end will be a final follow-up visit after 12 months. Participants will be invited for further follow-up visits up to 5 years. (not part of the present proposal) Implant survival/ success will be evaluated according to the criteria described by Buser et al. All seconda

Conditions

• Partial Edentulism Class 3

Interventions

Type	Name	Description
PROCEDURE	Immediate Implant Loading	A single implant crown will be mounted on the implant immediately after implant placement
PROCEDURE	Early Implant Loading	A single implant crown will be mounted on the implant 4 weeks after implant placement.

Timeline

• Start date: 2021-01-01
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2022-06-08
• Last updated: 2026-02-13

Locations

1 site across 1 country: Switzerland