Lower Molar Requiring ExtractionNCT04319042
Effect of Placing the Implant Crown on the Implant on the Same Day as the Implant vs. 4 Weeks Later.
A study testing Immediate Loading and Early Loading in people with Lower Molar Requiring Extraction, run by University of Bern at 2 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lower Molar Requiring Extraction
- What is being tested?
- Immediate Loading and Early Loading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Apr 2021to May 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Klinik für Oralchirurgie und Stomatologie
Bern, Canton of Bern, 3010
Simone FM Janner, PD. Dr.
- Recruiting
Klinik für rekonstruktive Zahnmedizin und Gerodontologie
Bern, Canton of Bern, 3010
Samir Abou-Ayash, Dr.med.dent.
About this study
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).
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.
Read the 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.
- Conditions
- Lower Molar Requiring Extraction
- Being tested
- Immediate Loading, Early Loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate LoadingProcedure or surgery
The implant receives an artificial tooth the same day as it is placed.
Early LoadingProcedure or surgery
The implant receives an artificial tooth 4 weeks after placement.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Loading | Active comparator | Group A. The implant receives an artificial tooth the same day as it is placed. Receives: Procedure: Immediate Loading |
| Early Loading | Active comparator | Group B. The implant receives an artificial tooth 4 weeks after placement. Receives: Procedure: Early Loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Apr 2021
- Primary completionDec 2026 (estimated)
- Study completionMay 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Molar Requiring ExtractionStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone FM Janner, PD Dr., Principal investigator, University of BernSamir Abou-Ayash, Dr.med.dent., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319042
- Sponsor's protocol ID
- ITI 1455_2019
- Status last verified
- Feb 2026
- First submitted
- 20 Mar 2020
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04319042
- Acronym / sponsor ID
- ITI 1455_2019
- Conditions
- Lower Molar Requiring Extraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2033 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Loading | Active comparator | Procedure: Immediate LoadingGroup A. The implant receives an artificial tooth the same day as it is placed. |
| Early Loading | Active comparator | Procedure: Early LoadingGroup B. The implant receives an artificial tooth 4 weeks after placement. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate LoadingThe implant receives an artificial tooth the same day as it is placed. | Procedure or surgery | Immediate Loading |
| Early LoadingThe implant receives an artificial tooth 4 weeks after placement. | Procedure or surgery | Early Loading |
Primary outcome
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
5 secondary outcomes
Prosthetic Success
Time frame: 10 years
Patient's satisfaction
Time frame: 10 years
Clinical peri-implant soft tissue dimensions
Time frame: 10 years
Crestal bone level
Time frame: 10 years
Accuracy of digital implant planning
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Lower Molar Requiring Extraction
Enrolling by invitation
Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling
Immediate Dental Implant Placement, Lower Molar Requiring Extraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simone FM Janner, PD Dr. principal investigator
University of Bern
Samir Abou-Ayash, Dr.med.dent. principal investigator
University of Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Loading and Early Loading in people with Lower Molar Requiring Extraction, run by University of Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone FM Janner, PD Dr. (+41316322566, ueberweiser.chir@zmk.unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.