Atraumatic Zirconia Abutment Versus Customized Composite Healing Abutment in Maxilla or Mandible.

NCT05748379 | Active Not Recruiting

• 1 other identifier: SIAAdenta
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.Males and females at least 18 years of age or older.
2. 2.One implant per patient.
3. 3.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.
4. 4.Lateral individual teeth (premolars and molars).
5. 5.Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall).
6. 6.The gingival contour of the tooth to be extracted - without recession.
7. 7.Adjacent anterior teeth have no periodontal loss.
8. 8.There are no implants in the adjacent teeth.
9. 9.Non-traumatic tooth extraction, which results in intact walls of the socket.
10. 10.Deep occlusion (severe, class II).
11. 11.The patient smokes a lot (more than 10 cigarettes per day).
12. 12.Systemic disease (osteoporosis).
13. 13.No initial stability has been achieved after the implant insertion procedure.

Conditions

Dental Implants; Humans; Dental Implants, Single-Tooth; Male; Female; Osseointegration; Dental Anxiety; Guided Surgery

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  Before surgery and immediately after surgery

Study Arms (2)

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.

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.

Procedure: Individual abutment

Interventions

Kompozite closure PROCEDURE

Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper.

Kompozite closure

Individual abutment PROCEDURE

Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment.

Individual abutment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SIA Adenta: lead

Study Sites (1)

Adenta

Riga, Latvija, LV-1045, Latvia

Location

Related Publications (4)

• 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.

  PMID: 33438320 BACKGROUND

• Sanz-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.

  PMID: 30246362 BACKGROUND

• Guidetti 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.

  PMID: 26194771 BACKGROUND

• Gnusins 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.

  PMID: 40692347 DERIVED

Related Links

• Customized sealing socket abutment (SSA) has been claimed to optimize the peri-implant hard and soft tissues in type 1 implant placement.
• 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).
• 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.

Study Officials

• Ģirts Šalms, Asoc.prof

  Riga Stradiņš University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each patient has their individual ID number
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of dental Surgery

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 28, 2023
• Study Start: February 28, 2023
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)