Tooth LossNCT06627023

3D Analysis of Peri-implant Soft Tissue with Two Different Connection Types

A study testing Implant Placement with Conical or Butt-Joint Connection in people with Tooth Loss, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Objectives: assessment of dimensional soft tissues change after single tooth gap implantation with a closed healing approach and using conical and butt-joint implant-abutment connection type. Read more about this study

Who is it for?: Ages 25 years and older
Conditions the study is for: Tooth Loss
What is being tested?: Implant Placement with Conical or Butt-Joint Connection
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteGermany
Study dates: 30 Jun 2020to 12 Jan 2024
Phase: Interventional
Are there results?: None posted in the registry

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 25 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Presence of a single tooth gap, completion of conservative and periodontal treatments, diagnostic preoperative models, and a recent panoramic radiograph not older than 6 months.

Who cannot join

Abnormal jaw anatomy, insufficient bone volume, bone conditions (e.g., cysts, tumors), oral mucosa abnormalities (e.g., lesions, diseases), untreated periodontal disease, acute inflammation, pregnancy, temporary medication contraindications, psychological issues (e.g., substance abuse), poor compliance, and general medical contraindications.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 14197

Other trials in Germany

About this study

Official title: 3D Analysis of PERI-IMPLANT SOFT TISSUE After Dental Implant Placement with CONICAL and BUTT-JOINT Connection: a 12-Month Randomized Control Trial

Objectives: assessment of dimensional soft tissues change after single tooth gap implantation with a closed healing approach and using conical and butt-joint implant-abutment connection type.

Material and Methods: forty patients were enrolled in the study and received randomly allocated implants with conical and butt-joint implant-abutment connection type. A standard healing abutment was placed after 6 months for two weeks. The definitive screw retained crowns were manufactured in a digital workflow. The soft tissue profile was digitized using IOS on following stages: pre-op, immediately, two, 7 and 14 days post-op, pre-exposure, immediately after exposure, two weeks after exposure (pre-delivery), immediately after crown delivery, 6 and 12 months after delivery. The intraoral scans were matched in the metrology software (Geomagic Control X). The mean maximum and mean average differences in mm were gathered to assess the soft tissues change. Various anamnesis parameters have been taken into account.

Conditions: Tooth Loss
Being tested: Implant Placement with Conical or Butt-Joint Connection
Keywords: Dental Implants, Implant-Abutment Connection Types, Conical Connection, Butt-Joint Connection, Peri-Implant Soft Tissue, Digital Monitoring
Medical subject headings: Tooth Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implant Placement with Conical or Butt-Joint ConnectionDevice
Thirty eight patients were enrolled in the study and received randomly allocated implants with conical and butt-joint implant-abutment connection type. A standard healing abutment was placed after 6 months for two weeks. The definitive screw retained crowns were manufactured in a digital workflow. The soft tissue profile was digitized using IOS on following stages: pre-op, post-op: immediately, two, 7 and 14 days, pre-exposure, immediately after exposure, two weeks after exposure (pre-delivery), immediately after crown delivery, 6 and 12 months post-op.

Study groups in NCT06627023
Study group	Role	What they receive
19 Patients Received Implants with Conical Connections	Active comparator	Thirty eight patients were enrolled and randomly assigned to receive implants with conical connection. For the first arm 19 patients received implants with conical connections. A standard healing abutment was placed after 6 months for two weeks. The definitive screw-retained crowns were manufactured digitally and delivered afterwards. The soft tissue changes were traced till 12 months post-op Receives: Device: Implant Placement with Conical or Butt-Joint Connection
19 Patients Received Implants with Butt-Joint Connections	Active comparator	Thirty eight patients were enrolled and randomly assigned to receive implants with butt-joint connection. For the first arm 19 patients received implants with conical connections. A standard healing abutment was placed after 6 months for two weeks. The definitive screw-retained crowns were manufactured digitally and delivered afterwards. The soft tissue changes were traced till 12 months post-op Receives: Device: Implant Placement with Conical or Butt-Joint Connection

What is being measured

The primary outcome is the main question the study is designed to answer.

Linear changes of soft tissue in mm
The primary outcome measure is the change in peri-implant soft tissue profile, quantified in millimeters, assessed at various stages post-op. This includes measurements taken at pre-operative, immediately post-operative, 2 days, 7 days, 14 days, pre-exposure, post-exposure, pre-delivery, immediately after crown delivery, and at 6 and 12 months after delivery.
Measured: Assessment at pre-op, immediately post-op, 2 days, 7 days, 14 days, pre-exposure, post-exposure, pre-delivery, immediately after crown delivery, 6 months, and 12 months.

Secondary outcomes (1)

Influence of anamnestic parameters
For all enrolled patients a detailed medical history was collected, including following parameters: sex, region, brushing, mouth rinsing, flossing, alcohol consumption, stress, periodontitis therapy, gingival biotype.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202012 Jan 2024

First posted4 Oct 2024
Study start30 Jun 2020
Primary completion10 Nov 2022
Study completion12 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Tooth LossStudies of the same condition, open and under way.
More trials run by Charite University, Berlin, GermanyThe 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
Model description: Example: This study uses a parallel-group design, where patients are randomly assigned to either a group with conical connection or a group with butt-joint connection. Soft tissue changes are digitally monitored over a 12-month period.
Masking: Single blind
Who is masked: Investigator
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06627023
Sponsor's protocol ID: EA4_111_24
Status last verified: Oct 2024
First submitted: 28 Sep 2024
Last updated: 4 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD will not be shared due to confidentiality concerns and the need to protect patient privacy.

Publications

1. Warreth, A., et al., Dental implants and single implant-supported restorations. J Ir Dent Assoc, 2013. 59(1): p. 32-43. 2. Wang, Y., et al., Patient satisfaction and oral health-related quality of life 10 years after implant placement. BMC Oral Health, 2021. 21(1). 3. Hebel, K., R. Gajjar, and T. Hofstede, Single-tooth replacement: bridge vs. implant-supported restoration. J Can Dent Assoc, 2000. 66(8): p. 435-8. 4. Gomez-Meda, R., J. Esquivel, and M.B. Blatz, The esthetic biological contour concept for implant restoration emergence profile design. Journal of Esthetic and Restorative Dentistry, 2021. 33(1): p. 173-184. 5. Kadkhodazadeh, M., et al., Timing of soft tissue management around dental implants: a suggested protocol. Gen Dent, 2017. 65(3): p. 50-56. 6. Siegenthaler, M., et al., Anterior implant restorations with a convex emergence profile increase the frequency of recession: 12-month results of a randomized controlled clinical trial. Journal of Clinical Periodontology, 2022. 49(11): p. 1145-1157. 7. Tavelli, L., et al., Peri-implant soft tissue phenotype modification and its impact on peri-implant health: A systematic review and network meta-analysis. Journal of Periodontology, 2021. 92(1): p. 21-44. 8. Gomez-Meda, R., J. Esquivel, and M.B. Blatz, The esthetic biological contour concept for implant restoration emergence profile design. J Esthet Restor Dent, 2021. 33(1): p. 173-184. 9. Luo, R.M., et al., Soft-Tissue Grafting Solutions. Dent Clin North Am, 2020. 64(2): p. 435-451. 10. Deeb, G.R. and J.G. Deeb, Soft Tissue Grafting Around Teeth and Implants. Oral Maxillofac Surg Clin North Am, 2015. 27(3): p. 425-48. 11. Jepsen, S., et al., Primary prevention of peri-implantitis: Managing peri-implant mucositis. Journal of Clinical Periodontology, 2015. 42: p. S152-S157. 12. Laleman, I. and F. Lambert, Implant connection and abutment selection as a predisposing and/or precipitating factor for peri-implant diseases: A review. Clin Implant Dent Relat Res, 202
15. Ruales-Carrera, E., et al., Peri-implant tissue management after immediate implant placement using a customized healing abutment. J Esthet Restor Dent, 2019. 31(6): p. 533-541. 16. Thoma, D.S., et al., Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res, 2018. 29 Suppl 15: p. 32-49. 17. Thoma, D.S., et al., Efficacy of soft tissue augmentation around dental implants and in partially edentulous areas: a systematic review. J Clin Periodontol, 2014. 41 Suppl 15: p. S77-91. 18. Ramanauskaite, A., et al., Three-dimensional changes of a porcine collagen matrix and free gingival grafts for soft tissue augmentation to increase the width of keratinized tissue around dental implants: a randomized controlled clinical study. Int J Implant Dent, 2023. 9(1): p. 13. 19. Mancini, L., et al., 3D surface defect map for characterising the buccolingual profile of peri-implant tissues. Int J Oral Implantol (Berl), 2023. 16(2): p. 105-113. 20. Buda, M., M. Bratos, and J.A. Sorensen, Accuracy of 3-dimensional computer-aided manufactured single-tooth implant definitive casts. J Prosthet Dent, 2018. 120(6): p. 913-918. 21. Kernen, F., et al., A review of virtual planning software for guided implant surgery - data import and visualization, drill guide design and manufacturing. BMC Oral Health, 2020. 20(1): p. 251. 22. Poppolo Deus, F. and A. Ouanounou, Chlorhexidine in Dentistry: Pharmacology, Uses, and Adverse Effects. Int Dent J, 2022. 72(3): p. 269-277. 23. Pesce, P., et al., Systematic review of some prosthetic risk factors for periimplantitis. J Prosthet Dent, 2015. 114(3): p. 346-50. 24. AlQarawi, F.K., et al., Microleakage and Bacterial Adhesion with Three Restorative Materials Used to Seal Screw-access Channels of Implant Abutments: An In vitro Study. Saudi J Med Med Sci, 2021. 9(3): p. 241-247. 25. Amornvit, P., D. Rokaya, and S. Sanohkan, Comparison of Accuracy of Current Ten Intraoral S
Farronato, D., et al., Behavior of Soft Tissue around Platform-Switched Implants and Non-Platform-Switched Implants: A Comparative Three-Year Clinical Study. J Clin Med, 2021. 10(13). 31. Rodrigues, V.V.M., et al., Is the clinical performance of internal conical connection better than internal non-conical connection for implant-supported restorations? A systematic review with meta-analysis of randomized controlled trials. J Prosthodont, 2023. 32(5): p. 382-391. 32. López-Marí, L., et al., Implant platform switching concept: an updated review. Med Oral Patol Oral Cir Bucal, 2009. 14(9): p. e450-4. 33. Schmitt, C.M., et al., Performance of conical abutment (Morse Taper) connection implants: a systematic review. J Biomed Mater Res A, 2014. 102(2): p. 552-74. 34. Gupta, S., et al., Platform switching technique and crestal bone loss around the dental implants: A systematic review. Ann Afr Med, 2019. 18(1): p. 1-6. 35. Ackermann, K.L., et al., Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year follow-up. Int J Implant Dent, 2020. 6(1): p. 14. 36. Ramanauskaite, A. and R. Sader, Esthetic complications in implant dentistry. Periodontol 2000, 2022. 88(1): p. 73-85. 37. Chow, Y.C. and H.L. Wang, Factors and techniques influencing peri-implant papillae. Implant Dent, 2010. 19(3): p. 208-19. 38. Stefanini, M., et al., Peri-implant Papillae Reconstruction at an Esthetically Failing Implant. Int J Periodontics Restorative Dent, 2020. 40(2): p. 213-222. 39. Smukler, H., F. Castellucci, and D. Capri, The role of the implant housing in obtaining aesthetics: generation of peri-implant gingivae and papillae--Part 1. Pract Proced Aesthet Dent, 2003. 15(2): p. 141-9; quiz 150.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enrolling by invitation
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All Tooth Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 3D Analysis of PERI-IMPLANT SOFT TISSUE After Dental Implant Placement with CONICAL and BUTT-JOINT Connection: a 12-Month Randomized Control Trial
ClinicalTrials.gov ID: NCT06627023
Acronym / sponsor ID: EA4_111_24
Conditions: Tooth Loss
Keywords: Dental Implants, Implant-Abutment Connection Types, Conical Connection, Butt-Joint Connection, Peri-Implant Soft Tissue, Digital Monitoring
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Charite University, Berlin, GermanyUniversity, hospital or other
Study start: 30 Jun 2020 (actual)
Primary completion: 10 Nov 2022 (actual)
Study completion: 12 Jan 2024 (actual)
First posted: 4 Oct 2024 (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.

Objectives: assessment of dimensional soft tissues change after single tooth gap implantation with a closed healing approach and using conical and butt-joint implant-abutment connection type.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: Example: This study uses a parallel-group design, where patients are randomly assigned to either a group with conical connection or a group with butt-joint connection. Soft tissue changes are digitally monitored over a 12-month period.

Arm	Type	Receives
19 Patients Received Implants with Conical Connections	Active comparator	Device: Implant Placement with Conical or Butt-Joint ConnectionThirty eight patients were enrolled and randomly assigned to receive implants with conical connection. For the first arm 19 patients received implants with conical connections. A standard healing abutment was placed after 6 months for two weeks. The definitive screw-retained crowns were manufactured digitally and delivered afterwards. The soft tissue changes were traced till 12 months post-op
19 Patients Received Implants with Butt-Joint Connections	Active comparator	Device: Implant Placement with Conical or Butt-Joint ConnectionThirty eight patients were enrolled and randomly assigned to receive implants with butt-joint connection. For the first arm 19 patients received implants with conical connections. A standard healing abutment was placed after 6 months for two weeks. The definitive screw-retained crowns were manufactured digitally and delivered afterwards. The soft tissue changes were traced till 12 months post-op

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Presence of a single tooth gap, completion of conservative and periodontal treatments, diagnostic preoperative models, and a recent panoramic radiograph not older than 6 months.

Key exclusion criteria (1 listed)

Abnormal jaw anatomy, insufficient bone volume, bone conditions (e.g., cysts, tumors), oral mucosa abnormalities (e.g., lesions, diseases), untreated periodontal disease, acute inflammation, pregnancy, temporary medication contraindications, psychological issues (e.g., substance abuse), poor compliance, and general medical contraindications.

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
Implant Placement with Conical or Butt-Joint ConnectionThirty eight patients were enrolled in the study and received randomly allocated implants with conical and butt-joint implant-abutment connection type. A standard healing abutment was placed after 6 months for two weeks. The definitive screw retained crowns were manufactured in a digital workflow. The soft tissue profile was digitized using IOS on following stages: pre-op, post-op: immediately, two, 7 and 14 days, pre-exposure, immediately after exposure, two weeks after exposure (pre-delivery), immediately after crown delivery, 6 and 12 months post-op.	Device	19 Patients Received Implants with Butt-Joint Connections, 19 Patients Received Implants with Conical Connections

Primary outcome

Linear changes of soft tissue in mm
Time frame: Assessment at pre-op, immediately post-op, 2 days, 7 days, 14 days, pre-exposure, post-exposure, pre-delivery, immediately after crown delivery, 6 months, and 12 months.
The primary outcome measure is the change in peri-implant soft tissue profile, quantified in millimeters, assessed at various stages post-op. This includes measurements taken at pre-operative, immediately post-operative, 2 days, 7 days, 14 days, pre-exposure, post-exposure, pre-delivery, immediately after crown delivery, and at 6 and 12 months after delivery.

1 secondary outcome

Influence of anamnestic parameters
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
Background1. Warreth, A., et al., Dental implants and single implant-supported restorations. J Ir Dent Assoc, 2013. 59(1): p. 32-43. 2. Wang, Y., et al., Patient satisfaction and oral health-related quality of life 10 years after implant placement. BMC Oral Health, 2021. 21(1). 3. Hebel, K., R. Gajjar, and T. Hofstede, Single-tooth replacement: bridge vs. implant-supported restoration. J Can Dent Assoc, 2000. 66(8): p. 435-8. 4. Gomez-Meda, R., J. Esquivel, and M.B. Blatz, The esthetic biological contour concept for implant restoration emergence profile design. Journal of Esthetic and Restorative Dentistry, 2021. 33(1): p. 173-184. 5. Kadkhodazadeh, M., et al., Timing of soft tissue management around dental implants: a suggested protocol. Gen Dent, 2017. 65(3): p. 50-56. 6. Siegenthaler, M., et al., Anterior implant restorations with a convex emergence profile increase the frequency of recession: 12-month results of a randomized controlled clinical trial. Journal of Clinical Periodontology, 2022. 49(11): p. 1145-1157. 7. Tavelli, L., et al., Peri-implant soft tissue phenotype modification and its impact on peri-implant health: A systematic review and network meta-analysis. Journal of Periodontology, 2021. 92(1): p. 21-44. 8. Gomez-Meda, R., J. Esquivel, and M.B. Blatz, The esthetic biological contour concept for implant restoration emergence profile design. J Esthet Restor Dent, 2021. 33(1): p. 173-184. 9. Luo, R.M., et al., Soft-Tissue Grafting Solutions. Dent Clin North Am, 2020. 64(2): p. 435-451. 10. Deeb, G.R. and J.G. Deeb, Soft Tissue Grafting Around Teeth and Implants. Oral Maxillofac Surg Clin North Am, 2015. 27(3): p. 425-48. 11. Jepsen, S., et al., Primary prevention of peri-implantitis: Managing peri-implant mucositis. Journal of Clinical Periodontology, 2015. 42: p. S152-S157. 12. Laleman, I. and F. Lambert, Implant connection and abutment selection as a predisposing and/or precipitating factor for peri-implant diseases: A review. Clin Implant Dent Relat Res, 202
Background15. Ruales-Carrera, E., et al., Peri-implant tissue management after immediate implant placement using a customized healing abutment. J Esthet Restor Dent, 2019. 31(6): p. 533-541. 16. Thoma, D.S., et al., Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res, 2018. 29 Suppl 15: p. 32-49. 17. Thoma, D.S., et al., Efficacy of soft tissue augmentation around dental implants and in partially edentulous areas: a systematic review. J Clin Periodontol, 2014. 41 Suppl 15: p. S77-91. 18. Ramanauskaite, A., et al., Three-dimensional changes of a porcine collagen matrix and free gingival grafts for soft tissue augmentation to increase the width of keratinized tissue around dental implants: a randomized controlled clinical study. Int J Implant Dent, 2023. 9(1): p. 13. 19. Mancini, L., et al., 3D surface defect map for characterising the buccolingual profile of peri-implant tissues. Int J Oral Implantol (Berl), 2023. 16(2): p. 105-113. 20. Buda, M., M. Bratos, and J.A. Sorensen, Accuracy of 3-dimensional computer-aided manufactured single-tooth implant definitive casts. J Prosthet Dent, 2018. 120(6): p. 913-918. 21. Kernen, F., et al., A review of virtual planning software for guided implant surgery - data import and visualization, drill guide design and manufacturing. BMC Oral Health, 2020. 20(1): p. 251. 22. Poppolo Deus, F. and A. Ouanounou, Chlorhexidine in Dentistry: Pharmacology, Uses, and Adverse Effects. Int Dent J, 2022. 72(3): p. 269-277. 23. Pesce, P., et al., Systematic review of some prosthetic risk factors for periimplantitis. J Prosthet Dent, 2015. 114(3): p. 346-50. 24. AlQarawi, F.K., et al., Microleakage and Bacterial Adhesion with Three Restorative Materials Used to Seal Screw-access Channels of Implant Abutments: An In vitro Study. Saudi J Med Med Sci, 2021. 9(3): p. 241-247. 25. Amornvit, P., D. Rokaya, and S. Sanohkan, Comparison of Accuracy of Current Ten Intraoral S
BackgroundFarronato, D., et al., Behavior of Soft Tissue around Platform-Switched Implants and Non-Platform-Switched Implants: A Comparative Three-Year Clinical Study. J Clin Med, 2021. 10(13). 31. Rodrigues, V.V.M., et al., Is the clinical performance of internal conical connection better than internal non-conical connection for implant-supported restorations? A systematic review with meta-analysis of randomized controlled trials. J Prosthodont, 2023. 32(5): p. 382-391. 32. López-Marí, L., et al., Implant platform switching concept: an updated review. Med Oral Patol Oral Cir Bucal, 2009. 14(9): p. e450-4. 33. Schmitt, C.M., et al., Performance of conical abutment (Morse Taper) connection implants: a systematic review. J Biomed Mater Res A, 2014. 102(2): p. 552-74. 34. Gupta, S., et al., Platform switching technique and crestal bone loss around the dental implants: A systematic review. Ann Afr Med, 2019. 18(1): p. 1-6. 35. Ackermann, K.L., et al., Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year follow-up. Int J Implant Dent, 2020. 6(1): p. 14. 36. Ramanauskaite, A. and R. Sader, Esthetic complications in implant dentistry. Periodontol 2000, 2022. 88(1): p. 73-85. 37. Chow, Y.C. and H.L. Wang, Factors and techniques influencing peri-implant papillae. Implant Dent, 2010. 19(3): p. 208-19. 38. Stefanini, M., et al., Peri-implant Papillae Reconstruction at an Esthetically Failing Implant. Int J Periodontics Restorative Dent, 2020. 40(2): p. 213-222. 39. Smukler, H., F. Castellucci, and D. Capri, The role of the implant housing in obtaining aesthetics: generation of peri-implant gingivae and papillae--Part 1. Pract Proced Aesthet Dent, 2003. 15(2): p. 141-9; quiz 150.
Individual participant dataSharing planned: No. IPD will not be shared due to confidentiality concerns and the need to protect patient privacy.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Implant Placement with Conical or Butt-Joint Connection in people with Tooth Loss, run by Charite University, Berlin, Germany at 1 site in Germany.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Oct 2024. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Linear changes of soft tissue in mm (time frame: Assessment at pre-op, immediately post-op, 2 days, 7 days, 14 days, pre-exposure, post-exposure, pre-delivery, immediately after crown delivery, 6 months, and 12 months.). 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 NCT06627023, which also lists 3 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 4 Oct 2024.