Dental ImplantsNCT05748379
Atraumatic Zirconia Abutment Versus Customized Composite Healing Abutment in Maxilla or Mandible.
A study testing Kompozite closure and Individual abutment in people with Dental Implants and Humans, run by SIA Adenta at 1 site in Latvia.
Trial summary
40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group). Randomisation envelopes will be used for randomisation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants, Humans, Dental Implants, Single-Tooth
- What is being tested?
- Kompozite closure and Individual abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteLatvia
- Study dates
- 28 Feb 2023to 22 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females at least 18 years of age or older.
- One implant per patient.
- Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data.
- Lateral individual teeth (premolars and molars).
- Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall).
- The gingival contour of the tooth to be extracted - without recession.
Show all 9Show fewer
- Adjacent anterior teeth have no periodontal loss.
- There are no implants in the adjacent teeth.
- Non-traumatic tooth extraction, which results in intact walls of the socket.
Who cannot join
- Deep occlusion (severe, class II).
- The patient smokes a lot (more than 10 cigarettes per day).
- Systemic disease (osteoporosis).
- No initial stability has been achieved after the implant insertion procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closure of a Guided Immediate Implant Placed in the Extraction Socket With Bone Augmentation in the Lateral Area of the Maxilla or Mandible, With a Temporary Composite Abutment vs With a Custom-made Zirconium Oxide Abutment.
40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group).
Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used.
Read more
Allogenic bone botiss maxgraft® cortical granules are used as graft material.
Inclusion criteria:
- Males and females at least 18 years of age or older.
- One implant per patient.
- Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data.
- Lateral individual teeth (premolars and molars).
- Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall).
- The gingival contour of the tooth to be extracted - without recession.
- Adjacent anterior teeth have no periodontal loss.
- There are no implants in the adjacent teeth.
- Non-traumatic tooth extraction, which results in intact walls of the socket.
Exclusion criteria:
- Deep occlusion (severe, class II).
- The patient smokes a lot (more than 10 cigarettes per day).
- Systemic disease (osteoporosis).
- No initial stability has been achieved after the implant insertion procedure.
Read the detailed description
General Notes
40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group).
Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used.
Allogenic bone botiss maxgraft® cortical granules are used as graft material.
Inclusion criteria:
- Males and females at least 18 years of age or older.
- One implant per patient.
- Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data.
- Lateral individual teeth (premolars and molars).
- Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall).
- The gingival contour of the tooth to be extracted - without recession.
- Adjacent anterior teeth have no periodontal loss.
- There are no implants in the adjacent teeth.
- Non-traumatic tooth extraction, which results in intact walls of the socket.
Exclusion criteria:
- Deep occlusion (severe, class II).
- The patient smokes a lot (more than 10 cigarettes per day).
- Systemic disease (osteoporosis).
- No initial stability has been achieved after the implant insertion procedure. 4.2. Surgical Procedures and Recovery Phase (see Annexes No. 1 and 2)
Group 1. Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper after tooth extraction with bone augmentation by using allogeneic bone.
- Non-traumatic extraction.
- Palatal position of tapered implant for premolars and centred position for molars (more commonly - in the septum) 3-4 mm below the buccal gum line or 1-2 mm below the bony protuberance.
- For premolars, the implant is placed palatally 2-3 mm to the buccal bone wall, for molars 2-3 mm to the buccal and lingual wall.
- Implant insertion.
- "Jump distance" sealing with allogeneic bone.
- Temporary closure with a composite shaper.
- Cone beam computed tomography with Carestream machine.
- Taking a photo.
- Scan with 3Shape TRIOS4 scanner.
After 3 months, a cone beam computed tomography is performed to evaluate changes in the crestal bone, the temporary restoration is screwed off and the presence/absence of bleeding is recorded. A digital impression is taken for a zirconium oxide crown made on Ti base and to assess soft tissue changes.
The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest.
While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later.
Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability. Measurements will be taken before, immediately after the surgery and 3 month later. By using STL files it will be possible to compare soft tissue stability.
Group 2. Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment after tooth extraction with bone augmentation by using allogeneic bone.
- Non-traumatic extraction.
- Palatal position of tapered implant for premolars and centred position for molars (more commonly - in the septum) 3-4 mm below the buccal gum line or 1-2 mm below the bony protuberance.
- For premolars, the implant is placed palatally 2-3 mm to the buccal bone wall, for molars 2-3 mm to the buccal and lingual wall.
- Implant insertion.
- "Jump distance" sealing with allogeneic bone.
- Closure with a zirconium oxide abutment.
- Cone beam computed tomography with Carestream machine.
- Taking a photo.
- Scan with 3Shape TRIOS4 scanner.
After 3 months, a cone beam computed tomography is performed to evaluate changes in the crestal bone, the custom-made abutment is screwed off and the presence/absence of bleeding is recorded. A digital impression is taken for a zirconium oxide crown and to assess soft tissue changes.
The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest.
While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later.
Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability. Measurements will be taken before, immediately after the surgery and 3 month later. By using STL files it will be possible to compare soft tissue stability.
Evaluation Phase
T1 (Basic): After the performance of final restoration: X-ray, photograph, scan, PD, BOP, RI.
T2: Follow-up after 3 months: X-ray, photograph, scan, PD, BOP, RI. T3: Follow-up after a year: X-ray, photograph, scan, PD, BOP, RI.
- Conditions
- Dental Implants, Humans, Dental Implants, Single-Tooth, Male, Female, Osseointegration
- Being tested
- Kompozite closure, Individual abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kompozite closureProcedure or surgery
Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper.
Individual abutmentProcedure or surgery
Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment.
| Study group | Role | What they receive |
|---|---|---|
| Kompozite closure | Other | Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper after tooth extraction with bone augmentation by using allogeneic bone. Receives: Procedure: Kompozite closure |
| Individual abutment | Other | Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment after tooth extraction with bone augmentation by using allogeneic bone. Receives: Procedure: Individual abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of crestal bone
To compare crystal bone stability CBCT will be taken before surgery. , immediately after surgery, after 3 month and a follow up after 1 year.
The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest.
While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later
Measured: Before surgery, immediately after surgery, 3 moth, 1 year follow up
The changes of stability of soft tissue
Recession (REC) state of the gingival/mucosa border - registered by means of a periodontal probe from the incisal edge to the border of the medial, zenith and distal zones.
There are taken scans with 3Shape Trios4 before surgery, immediately after, then 3 month and 1 year follow up to compare soft tissue stability
Measured: Before surgery, immediately after surgery, 3 month, 1 year follow up
The change of position of implant using surgical guide
To compare implant position accuracy using surgical guide, the following two things will be compared: DICOM after the surgery witch contains information on the implant position in the bone and the STL file witch contains information on implant position before the surgery.
There are taken cone beam computer tomography before and immediately after surgery, then 3 month and 1 year follow up.
Measured: Before surgery and immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start28 Feb 2023
- Primary completion22 May 2024
- Study completion22 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SIA Adenta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vitālijs Gnusins, SIA Adenta
- Investigators
- Ģirts Šalms, Asoc.prof, Study director, Riga Stradiņš University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748379
- Sponsor's protocol ID
- SIAAdenta
- Status last verified
- May 2025
- First submitted
- 11 Jan 2023
- Last updated
- 14 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alexopoulou M, Lambert F, Knafo B, Popelut A, Vandenberghe B, Finelle G. Immediate implant in the posterior region combined with alveolar ridge preservation and sealing socket abutment: A retrospective 3D radiographic analysis. Clin Implant Dent Relat Res. 2021 Feb;23(1):61-72. doi: 10.1111/cid.12974. Epub 2021 Jan 13.
PubMed 33438320Sanz-Martin I, Permuy M, Vignoletti F, Nunez J, Munoz F, Sanz M. A novel methodological approach using superimposed Micro-CT and STL images to analyze hard and soft tissue volume in immediate and delayed implants with different cervical designs. Clin Oral Implants Res. 2018 Oct;29(10):986-995. doi: 10.1111/clr.13365. Epub 2018 Sep 23.
PubMed 30246362Guidetti LG, Monnazzi MS, Piveta AC, Gabrielli MA, Gabrielli MF, Pereira Filho VA. Evaluation of single implants placed in the posterior mandibular area under immediate loading: a prospective study. Int J Oral Maxillofac Surg. 2015 Nov;44(11):1411-5. doi: 10.1016/j.ijom.2015.06.021. Epub 2015 Jul 18.
PubMed 26194771Gnusins V, Akhondi S, Zvirblis T, Pala K, Gallucci GO, Puisys A. Chairside vs Prefabricated Sealing Socket Abutments for Posterior Immediate Implants: A Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Aug;27(4):e70076. doi: 10.1111/cid.70076.
PubMed 40692347
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure of a Guided Immediate Implant Placed in the Extraction Socket With Bone Augmentation in the Lateral Area of the Maxilla or Mandible, With a Temporary Composite Abutment vs With a Custom-made Zirconium Oxide Abutment.
- ClinicalTrials.gov ID
- NCT05748379
- Acronym / sponsor ID
- SIAAdenta
- Conditions
- Dental Implants, Humans, Dental Implants, Single-Tooth, Male, Female, Osseointegration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- SIA AdentaUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2025 (estimated)
- First posted
- 28 Feb 2023 (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.
40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group).
Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used.
Allogenic bone botiss maxgraft® cortical granules are used as graft material.
Inclusion criteria:
- Males and females at least 18 years of age or older.
- One implant per patient.
- Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data.
- Lateral individual teeth (premolars and molars).
- Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall).
- The gingival contour of the tooth to be extracted - without recession.
- Adjacent anterior teeth have no periodontal loss.
- There are no implants in the adjacent teeth.
- Non-traumatic tooth extraction, which results in intact walls of the socket.
Exclusion criteria:
- Deep occlusion (severe, class II).
- The patient smokes a lot (more than 10 cigarettes per day).
- Systemic disease (osteoporosis).
- No initial stability has been achieved after the implant insertion procedure.
Detailed description
General Notes
40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group).
Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used.
Allogenic bone botiss maxgraft® cortical granules are used as graft material.
Inclusion criteria:
- Males and females at least 18 years of age or older.
- One implant per patient.
- Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data.
- Lateral individual teeth (premolars and molars).
- Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall).
- The gingival contour of the tooth to be extracted - without recession.
- Adjacent anterior teeth have no periodontal loss.
- There are no implants in the adjacent teeth.
- Non-traumatic tooth extraction, which results in intact walls of the socket.
Exclusion criteria:
- Deep occlusion (severe, class II).
- The patient smokes a lot (more than 10 cigarettes per day).
- Systemic disease (osteoporosis).
- No initial stability has been achieved after the implant insertion procedure. 4.2. Surgical Procedures and Recovery Phase (see Annexes No. 1 and 2)
Group 1. Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper after tooth extraction with bone augmentation by using allogeneic bone.
- Non-traumatic extraction.
- Palatal position of tapered implant for premolars and centred position for molars (more commonly - in the septum) 3-4 mm below the buccal gum line or 1-2 mm below the bony protuberance.
- For premolars, the implant is placed palatally 2-3 mm to the buccal bone wall, for molars 2-3 mm to the buccal and lingual wall.
- Implant insertion.
- "Jump distance" sealing with allogeneic bone.
- Temporary closure with a composite shaper.
- Cone beam computed tomography with Carestream machine.
- Taking a photo.
- Scan with 3Shape TRIOS4 scanner.
After 3 months, a cone beam computed tomography is performed to evaluate changes in the crestal bone, the temporary restoration is screwed off and the presence/absence of bleeding is recorded. A digital impression is taken for a zirconium oxide crown made on Ti base and to assess soft tissue changes.
The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest.
While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later.
Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability. Measurements will be taken before, immediately after the surgery and 3 month later. By using STL files it will be possible to compare soft tissue stability.
Group 2. Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment after tooth extraction with bone augmentation by using allogeneic bone.
- Non-traumatic extraction.
- Palatal position of tapered implant for premolars and centred position for molars (more commonly - in the septum) 3-4 mm below the buccal gum line or 1-2 mm below the bony protuberance.
- For premolars, the implant is placed palatally 2-3 mm to the buccal bone wall, for molars 2-3 mm to the buccal and lingual wall.
- Implant insertion.
- "Jump distance" sealing with allogeneic bone.
- Closure with a zirconium oxide abutment.
- Cone beam computed tomography with Carestream machine.
- Taking a photo.
- Scan with 3Shape TRIOS4 scanner.
After 3 months, a cone beam computed tomography is performed to evaluate changes in the crestal bone, the custom-made abutment is screwed off and the presence/absence of bleeding is recorded. A digital impression is taken for a zirconium oxide crown and to assess soft tissue changes.
The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest.
While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later.
Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability. Measurements will be taken before, immediately after the surgery and 3 month later. By using STL files it will be possible to compare soft tissue stability.
Evaluation Phase
T1 (Basic): After the performance of final restoration: X-ray, photograph, scan, PD, BOP, RI.
T2: Follow-up after 3 months: X-ray, photograph, scan, PD, BOP, RI. T3: Follow-up after a year: X-ray, photograph, scan, PD, BOP, RI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kompozite closure | Other | Procedure: Kompozite closureImmediate implant placement and temporary closure of tapered implants with a custom-made composite shaper after tooth extraction with bone augmentation by using allogeneic bone. |
| Individual abutment | Other | Procedure: Individual abutmentImmediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment after tooth extraction with bone augmentation by using allogeneic bone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females at least 18 years of age or older.
- One implant per patient.
- Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data.
- Lateral individual teeth (premolars and molars).
- Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall).
Key exclusion criteria (4 listed)
- Deep occlusion (severe, class II).
- The patient smokes a lot (more than 10 cigarettes per day).
- Systemic disease (osteoporosis).
- No initial stability has been achieved after the implant insertion procedure
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 |
|---|---|---|
| Kompozite closureImmediate implant placement and temporary closure of tapered implants with a custom-made composite shaper. | Procedure or surgery | Kompozite closure |
| Individual abutmentImmediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment. | Procedure or surgery | Individual abutment |
Primary outcome
Stability of crestal bone
Time frame: Before surgery, immediately after surgery, 3 moth, 1 year follow up
To compare crystal bone stability CBCT will be taken before surgery. , immediately after surgery, after 3 month and a follow up after 1 year. The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest. While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later
The changes of stability of soft tissue
Time frame: Before surgery, immediately after surgery, 3 month, 1 year follow up
Recession (REC) state of the gingival/mucosa border - registered by means of a periodontal probe from the incisal edge to the border of the medial, zenith and distal zones. There are taken scans with 3Shape Trios4 before surgery, immediately after, then 3 month and 1 year follow up to compare soft tissue stability
The change of position of implant using surgical guide
Time frame: Before surgery and immediately after surgery
To compare implant position accuracy using surgical guide, the following two things will be compared: DICOM after the surgery witch contains information on the implant position in the bone and the STL file witch contains information on implant position before the surgery. There are taken cone beam computer tomography before and immediately after surgery, then 3 month and 1 year follow up.
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 14 May 2025.
- Results publication: PubMed 33438320Alexopoulou M, Lambert F, Knafo B, Popelut A, Vandenberghe B, Finelle G. Immediate implant in the posterior region combined with alveolar ridge preservation and sealing socket abutment: A retrospective 3D radiographic analysis. Clin Implant Dent Relat Res. 2021 Feb;23(1):61-72. doi: 10.1111/cid.12974. Epub 2021 Jan 13.
- Results publication: PubMed 30246362Sanz-Martin I, Permuy M, Vignoletti F, Nunez J, Munoz F, Sanz M. A novel methodological approach using superimposed Micro-CT and STL images to analyze hard and soft tissue volume in immediate and delayed implants with different cervical designs. Clin Oral Implants Res. 2018 Oct;29(10):986-995. doi: 10.1111/clr.13365. Epub 2018 Sep 23.
- Results publication: PubMed 26194771Guidetti LG, Monnazzi MS, Piveta AC, Gabrielli MA, Gabrielli MF, Pereira Filho VA. Evaluation of single implants placed in the posterior mandibular area under immediate loading: a prospective study. Int J Oral Maxillofac Surg. 2015 Nov;44(11):1411-5. doi: 10.1016/j.ijom.2015.06.021. Epub 2015 Jul 18.
- Derived from this study: PubMed 40692347Gnusins V, Akhondi S, Zvirblis T, Pala K, Gallucci GO, Puisys A. Chairside vs Prefabricated Sealing Socket Abutments for Posterior Immediate Implants: A Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Aug;27(4):e70076. doi: 10.1111/cid.70076.
- Customized sealing socket abutment (SSA) has been claimed to optimize the peri-implant hard and soft tissues in type 1 implant placement.Link provided by the sponsor.
- To study the hard and soft tissue volume after placing immediate (IMI) or delayed implants (DLI) with a triangular coronal macro-design (Test/T) or a conventional cylindrical design (Control/C).Link provided by the sponsor.
- The aim of this study was to evaluate the survival of single dental implants subjected to immediate function. Twelve patients with edentulous areas in the posterior mandible were included in the study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ģirts Šalms, Asoc.prof study director
Riga Stradiņš University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kompozite closure and Individual abutment in people with Dental Implants and Humans, run by SIA Adenta at 1 site in Latvia.
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 4 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 14 May 2025. 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 Latvia. 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?
Stability of crestal bone (time frame: Before surgery, immediately after surgery, 3 moth, 1 year follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05748379, which also lists 4 linked publications.
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 14 May 2025.