NCT05748379

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

Active, enrolled NA Last updated 14 May 2025

What this trial tests

NA trial testing Kompozite closure in Dental Implants in 44 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 February 2023

Primary endpoint
22 May 2024

22 May 2025

Quick facts

Lead sponsor	SIA Adenta
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	44
Start date	28 February 2023
Primary completion	22 May 2024
Estimated completion	22 May 2025
Sites	1 location across Latvia

Drugs / interventions tested

• Kompozite closure
• Individual abutment

Conditions studied

• Dental Implants — all drugs for Dental Implants →
• Humans — all drugs for Humans →
• Dental Implants, Single-Tooth — all drugs for Dental Implants, Single-Tooth →
• Male — all drugs for Male →

Sponsor

SIA Adenta

Who can join

18 and older, any sex, with Dental Implants or Humans. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. Males and females at least 18 years of age or older.
2. One implant per patient.
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. Lateral individual teeth (premolars and molars).
5. Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall).
6. The gingival contour of the tooth to be extracted - without recession.
7. Adjacent anterior teeth have no periodontal loss.
8. There are no implants in the adjacent teeth.
9. Non-traumatic tooth extraction, which results in intact walls of the socket.

Exclusion criteria:

1. Deep occlusion (severe, class II).
2. The patient smokes a lot (more than 10 cigarettes per day).
3. Systemic disease (osteoporosis).
4. No initial stability has been achieved after the implant insertion procedure.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Chairside vs Prefabricated Sealing Socket Abutments for Posterior Immediate Implants: A Randomized Clinical Trial.
   Gnusins V, Akhondi S, Zvirblis T, Pala K, et al · · 2025 · cited 1× · PMID 40692347 · DOI 10.1111/cid.70076