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

NCT05748379 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-05-14

No results posted yet for this study

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. 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.

Conditions

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

Interventions

PROCEDURE

Kompozite closure

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

PROCEDURE

Individual abutment

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

Sponsors & Collaborators

  • SIA Adenta

    lead OTHER

Principal Investigators

  • Ģirts Šalms, Asoc.prof · Riga Stradiņš University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-05-22
Completion
2025-05-22

Countries

  • Latvia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05748379 on ClinicalTrials.gov