Immediate Loading in Single Tooth Implants

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.

Conditions

• Partial Edentulism Class 3

Interventions

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.

Sponsors & Collaborators

• ITI International Team for Implantology, Switzerland

  collaborator OTHER

• University of Bern

  lead OTHER

Principal Investigators

• Samir Abou-Ayash, PD Dr. · University of Bern

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2026-01-01

Completion

2026-06-01

Countries

• Switzerland

Study Locations