Effect of Placing the Implant Crown on the Implant on the Same Day as the Implant vs. 4 Weeks Later.

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

In this study, participants with one lower first molar that require removal and replacement using dental implants will be enrolled. The implant will be inserted 12-16 weeks after tooth extraction and restored either immediately with an artificial tooth (fixed implant crown) in 50% of the cases or 4 weeks later in the remainder 50%. Immediate and early loading will be compared and the investigators expect no difference in terms of implant success and health of the tissue around the implant.

Study Overview

• Status: Recruiting
• Conditions: Lower Molar Requiring Extraction
• Intervention / Treatment: Procedure: Immediate Loading; Procedure: Early Loading

Detailed Description

Background

Dental implants placed between 12 and 16 weeks after tooth loss are a well-documented treatment option. Placing the artificial tooth (implant crown) on the implant the same day (immediate loading) or approximately 4 weeks after implant placement (early loading) are also treatment options with good scientific documentation. Computer-assisted implant surgery (sCAIS) and modern implant materials/surfaces increase treatment predictability and success in this context.

Clinical relevance

The timing of implant placement post-extraction and subsequent implant loading cannot be separated in modern implant therapy any longer. At the "Sixth ITI Consensus Conference" in Amsterdam, it was concluded that the clinical evidence and documentation of early implant placement combined with immediate or early implant loading in partially edentulous patients is currently insufficiently documented. However, this treatment protocol seems to be widely applied in daily practice. 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 loading protocol.

Hypothesis/Specific aims

H0: "Early placed single tooth implants by means of static computer-assisted implant surgery (sCAIS) in mandibular first molar sites with immediately loaded provisionals, show a survival rate comparable to early placed implants with an early loading protocol." Secondary parameters to be evaluated will be the prosthetic survival/ success, patient-centered outcomes (PROs), clinical peri-implant conditions, bone-level changes, alteration of peri-implant soft-tissue dimensions and the accuracy of digital implant planning.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simone FM Janner, PD Dr.; Phone Number: +41316322566; Email: ueberweiser.chir@zmk.unibe.ch
• Study Contact Backup: Name: Samir Abou-Ayash, Dr.med.dent.; Phone Number: +41316322586; Email: ueberweiser.chir@zmk.unibe.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Klinik für Oralchirurgie und Stomatologie
    • Contact: Simone FM Janner, PD. Dr.
  • Bern, Switzerland, 3010
    • Recruiting
    • Klinik für rekonstruktive Zahnmedizin und Gerodontologie
    • Contact: Samir Abou-Ayash, Dr.med.dent.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 20 years
• Willingness to sign informed consent and to participate in the study
• Plaque index according to Silness and Loe of < 35% [26]
• 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

Exclusion Criteria:

• 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
• Intention to become pregnant between inclusion and implant loading
• Heavy smoking habit with ≥ 10 cig/d
• Severe bruxism or clenching habits, present oro-facial pain
• Insufficient ridge width/height for the study implant
• Defect of any alveolar wall (secondary exclusion criterion at tooth extraction)
• ISQ < 70 (secondary exclusion criterion for Group A at implant placement, for Group B at loading visit)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Immediate Loading; Group A. The implant receives an artificial tooth the same day as it is placed.	Procedure: Immediate Loading; The implant receives an artificial tooth the same day as it is placed.
Active Comparator: Early Loading; Group B. The implant receives an artificial tooth 4 weeks after placement.	Procedure: Early Loading; The implant receives an artificial tooth 4 weeks after placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survival	Number of implants from both groups (i.e. immediate loading vs. early loading) fulfilling the criteria of survival and success after 12 months. The criteria are: 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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthetic Success	Esthetics and correct function of the implant prosthetic will be analyzed by means of palpation, inspection and probing. Any prosthetic complication, e.g. chipping, screw loosening will be recorded.	10 years
Patient's satisfaction	Patient's satisfaction with the treatment result will be analyzed by means of questions (both oral and written, using validated questionnaires)	10 years
Clinical peri-implant soft tissue dimensions	Probing depth of the soft tissue surrounding the implant will be assessed using palpation, inspection and a periodontal probe.	10 years
Crestal bone level	Crestal bone-level changes will be assessed in the follow-up radiographs that are taken routinely after any implant treatment, using a dedicated imaging software.	10 years
Accuracy of digital implant planning	The difference between digitally planned and real/final implant position will be analyzed by superimposing the digitized final impression and the digital preoperative planning with the dedicated software. No additional exposure to radiation or additional impressions will be necessary.	12 months

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Principal Investigator: SImone FM Janner, PD Dr., University of Bern; Principal Investigator: Samir Abou-Ayash, Dr.med.dent., University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2033

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ITI 1455_2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No