Effect of Placing the Implant Crown on the Implant on the Same Day as the Implant vs. 4 Weeks Later.
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|ClinicalTrials.gov Identifier: NCT04319042|
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : June 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lower Molar Requiring Extraction||Procedure: Immediate Loading Procedure: Early Loading||Not Applicable|
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.
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.
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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).|
|Estimated Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||April 30, 2033|
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.
- Implant Survival [ Time Frame: 12 months ]
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
- Prosthetic Success [ Time Frame: 10 years ]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.
- Patient's satisfaction [ Time Frame: 10 years ]Patient's satisfaction with the treatment result will be analyzed by means of questions (both oral and written, using validated questionnaires)
- Clinical peri-implant soft tissue dimensions [ Time Frame: 10 years ]Probing depth of the soft tissue surrounding the implant will be assessed using palpation, inspection and a periodontal probe.
- Crestal bone level [ Time Frame: 10 years ]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.
- Accuracy of digital implant planning [ Time Frame: 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319042
|Contact: Simone FM Janner, PD Dr.||+email@example.com|
|Contact: Samir Abou-Ayash, Dr.firstname.lastname@example.org|
|Klinik für Oralchirurgie und Stomatologie|
|Bern, Switzerland, 3010|
|Contact: Simone FM Janner, PD. Dr.|
|Klinik für rekonstruktive Zahnmedizin und Gerodontologie|
|Bern, Switzerland, 3010|
|Contact: Samir Abou-Ayash, Dr.med.dent.|
|Principal Investigator:||Simone FM Janner, PD Dr.||University of Bern|
|Principal Investigator:||Samir Abou-Ayash, Dr.med.dent.||University of Bern|