Immediate Loading in Single Tooth Implants

NCT05409287 | Active Not Recruiting DMC

• 1 other identifier: ITI 1400_2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Implant survival/success

  An implant that is still in place 1 year after placement will be considered surviving. Implant success and survival rate will be defined according to established criteria : A surviving implant is defined as an implant in place at the time of the follow-up. A particular implant will be deemed a success if all of the following success criteria apply: Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (e. g. painful sensation) . Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if observed at two or more follow-up visits after the treatment with systemic antibiotics) . Absence of implant mobility on manual palpation . Absence of any continuous peri-implant radiolucency

  1 year

Secondary Outcomes (3)

• Prosthetic Success/ survival

  1 year

• Accuracy of guided surgery

  1 year

• Patient satisfaction

  1 year

Study Arms (2)

Immediate Implant Loading

EXPERIMENTAL

A provisional single implant crown will be mounted on an implant, placed 16 weeks post tooth extraction, immediately after implant placement. Occlusion will be adjusted, so that there is no occlusal contact with the 8 µm Shim Stock foil (Hanel Shim Stock Foil; Coltène/Whaledent AG, Altsätten, Switzerland), but contact with 40µm occlusion foil (Hanel Articulating Paper, Coltène/Whaledent AG, Altsätten, Switzerland) during static occlusion. All dynamic contacts will be eliminated by intraoral grinding with a diamond bur, and the occlusal surface will be polished afterward. The screw access channel will be sealed by a Teflon strip and a provisional light-polymerizing resin (Telio CS, Ivoclar Vivadent AG, Schaan, Liechtenstein). In case of a mini-flap on the buccal aspect, the flaps will then be sutured around the implant healing cap or the implant provisional with single interrupted sutures. Finally, a periapical radiograph will be taken, using the customized x-ray tray.

Procedure: Immediate Implant Loading

Early Implant Loading

ACTIVE COMPARATOR

A provisional single implant crown will be mounted on an implant, placed 16 weeks post tooth extraction, 4 weeks after implant placement. Occlusion will be adjusted, so that there is no occlusal contact with the 8 µm Shim Stock foil (Hanel Shim Stock Foil; Coltène/Whaledent AG, Altsätten, Switzerland), but contact with 40µm occlusion foil (Hanel Articulating Paper, Coltène/Whaledent AG, Altsätten, Switzerland) during static occlusion. All dynamic contacts will be eliminated by intraoral grinding with a diamond bur, and the occlusal surface will be polished afterward. The screw access channel will be sealed by a Teflon strip and a provisional light-polymerizing resin (Telio CS, Ivoclar Vivadent AG, Schaan, Liechtenstein). In case of a mini-flap on the buccal aspect, the flaps will then be sutured around the implant healing cap or the implant provisional with single interrupted sutures. Finally, a periapical radiograph will be taken, using the customized x-ray tray.

Procedure: Early Implant Loading

Interventions

Immediate Implant Loading PROCEDURE

A single implant crown will be mounted on the implant immediately after implant placement

Immediate Implant Loading

Early Implant Loading PROCEDURE

A single implant crown will be mounted on the implant 4 weeks after implant placement.

Early Implant Loading

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 20 years
• Willingness to sign informed consent and to participate in the study
• Plaque index according to Silness and Loe of \< 35% \[26\]
• At site level:
• Presence of a mandibular first molar that has to be extracted
• Sufficient vertical interocclusal space for the placement of an implant crown (7 mm)
• Presence of an opposing natural or artificial tooth
• Ridge height sufficient for the placement of a ≥ 10 mm-long implant
• Sufficient ridge width for the placement of a 4.1mm diameter implant

You may not qualify if:

• At patient level:
• Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance to the protocol
• Any disorder that would interfere with wound healing or represent a contraindication for implant surgery such as, but not limited to, uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates
• Pregnancy or lactation
• Heavy smoking habit with ≥ 10 cig/d
• Severe bruxism or clenching habits, present oro-facial pain at site level
• Insufficient ridge width/height for the study implant

Sponsors & Collaborators

• University of Bern: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

Department of Reconstructive Dentistry, University of Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• Samir Abou-Ayash, PD Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: January 1, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)