Partial Edentulism Class 3NCT05409287
Immediate Loading in Single Tooth Implants
A study testing Immediate Implant Loading and Early Implant Loading in people with Partial Edentulism Class 3, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Partial Edentulism Class 3
- What is being tested?
- Immediate Implant Loading and Early Implant Loading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2021to 1 Jun 2026
- 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]
- 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)
Show all 9Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Reconstructive Dentistry, University of Bern
Bern, 3010
About this study
Official title: Influence of the Implant Loading Protocol on Implant Survival in Early Placed Single-tooth Implants in Mandibular Posterior Sites Using Computer-assisted Implant Surgery: A Randomized Clinical Trial (RCT)
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
Read more
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.
Read the detailed description
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 seconda
- Conditions
- Partial Edentulism Class 3
- Being tested
- Immediate Implant Loading, Early Implant Loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Implant LoadingProcedure or surgery
A single implant crown will be mounted on the implant immediately after implant placement
Early Implant LoadingProcedure or surgery
A single implant crown will be mounted on the implant 4 weeks after implant placement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Early Implant Loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
Prosthetic Success/ survival
During the prosthodontic examination, the implant supported prostheses will be examined for any complications and failures. Possible complications are: loss of retention , fracture and/or chipping, loosening of occlusal screw , fracture of occlusal screw , loosening of abutment , fracture of abutment. Prosthetic success is defined as the non-occurrence of any complications. If any complication occurs, but the crown is still in place, it will be considered surviving.
Measured: 1 year
Accuracy of guided surgery
The accuracy of the final- compared to the digitally planned implant position, will be measured according to a previously conducted study at the University of Bern. Standard tessellation language (STL) files of the post-surgical implant scan will be imported into the coDiagnostiX software containing the previous digital plan. Treatment evaluation feature will be used to compare pre-planned to post-surgical implant positions. Virtually planned and postoperative implant STL files will be superimposed using the same occlusal/incisal surfaces of teeth as a reference. Angular and 3D deviation at implant crest and implant apex will be measured. The measurements will be performed by two independent examiners unaware of the treatment modalities.
Measured: 1 year
Patient satisfaction
Patient satisfaction will be evaluated by means of a 10mm visual analogue scale (VAS) based questionnaire, which is administered after training the participant in using this form of scale. The evaluated items of the questionnaire will be the ease of cleaning, general satisfaction, comfort, aesthetics, stability, chewing ability and function.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jan 2021
- Primary completion1 Jan 2026
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Edentulism Class 3Studies of the same condition, open and under way.
- 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
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Sponsor
- Investigators
- Samir Abou-Ayash, PD Dr., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409287
- Sponsor's protocol ID
- ITI 1400_2019
- Status last verified
- Feb 2026
- First submitted
- 3 Jun 2022
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 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 Posterior Sites Using Computer-assisted Implant Surgery: A Randomized Clinical Trial (RCT)
- ClinicalTrials.gov ID
- NCT05409287
- Acronym / sponsor ID
- ITI 1400_2019
- Conditions
- Partial Edentulism Class 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 8 Jun 2022 (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.
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.
Detailed description
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 seconda
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Implant Loading | Experimental | Procedure: Immediate Implant LoadingA 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. |
| Early Implant Loading | Active comparator | Procedure: Early Implant LoadingA 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 (7 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
- Heavy smoking habit with ≥ 10 cig/d
- Severe bruxism or clenching habits, present oro-facial pain at site level
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 Implant LoadingA single implant crown will be mounted on the implant immediately after implant placement | Procedure or surgery | Immediate Implant Loading |
| Early Implant LoadingA single implant crown will be mounted on the implant 4 weeks after implant placement. | Procedure or surgery | Early Implant Loading |
Primary outcome
Implant survival/success
Time frame: 1 year
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
3 secondary outcomes
Prosthetic Success/ survival
Time frame: 1 year
Accuracy of guided surgery
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
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 13 Feb 2026.
- Individual participant dataSharing planned: No. Data may be made available upon request.
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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. This study is not recruiting at the moment.
Samir Abou-Ayash, PD Dr. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Implant Loading and Early Implant Loading in people with Partial Edentulism Class 3, run by University of Bern at 1 site 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 9 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival/success (time frame: 1 year). 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 13 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.