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NCT05592821

Clinical and Radiographic Evaluation of Bone and Tissue Level Single Unit Implants: Two-piece Abutment Concept

Completed Last updated 18 March 2024
What this trial tests

trial testing dental implant placement in Bone Loss, Alveolar in 20 participants. Completed in 26 September 2023.

Timeline
7 December 2020
Primary endpoint
26 September 2022
26 September 2023

Quick facts

Lead sponsorBerceste Guler
StatusCompleted
Study typeOBSERVATIONAL
Enrollment20
Start date7 December 2020
Primary completion26 September 2022
Estimated completion26 September 2023
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Berceste Guler

Who can join

Adults 18 to 65, any sex, with Bone Loss, Alveolar or Dental Implant Failed. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Dental implants have become one of the most common treatments used for the rehabilitation of lost teeth. The success rate of dental implant treatment is quite high. One of the criteria used for long-term implant success is the evaluation of radiographic marginal bone loss. Implants are used at the bone and tissue level in implant treatment. In this study, it was planned to use 20 implants of the same brand, with a single implant in the bilateral posterior regions in 10 patients.The study will be designed as split-mouth. The implant will be placed at the bone level with the same protocol in the two edentulous areas and the flap will be closed primarily. After 3 months, the substructure of the two-piece abutment concept system will be placed in a region during the healing head placement stage, and the bone level implant will be converted to the tissue level. A conventional healing cap will be placed in the other area. Periapical radiographs will be taken from the patients who participated in our study, as in all implant patients, during the pre-surgical planning phase and after implant placement. With the control periapical radiographs to be taken as a result of one-year follow-up, the marginal bone loss amount in the implants will be evaluated using soft-ware. Clinical measurements will be taken in all patients at the prosthetic loading session and 1 year after loading.

Publications & conference data

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

  1. The Effect of Two-Piece Abutment Concept and Abutment Reconnection/Disconnection on Marginal Bone Level Changes: A Split-Mouth Randomized, Parallel-Designed, 36-Month Follow-Up, Preliminary Clinical Study.
    Ayyildiz BG, Terzioglu B, Bayindir BC. · · 2025 · PMID 40907027 · DOI 10.11607/jomi.11454

Verify or expand the search:

Other trials of dental implant placement

Trials testing the same drug.

Other recruiting trials for Bone Loss, Alveolar

Currently open trials in the same condition.

Other Berceste Guler trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05592821.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing