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NCT06250621

Manual or Digitally Guided Surgical Technique for Replacing Single Tooth Edentulism by Means of Sub-crestally Placed Implants. A 3-year Parallel Randomized Clinical Study on Marginal Bone Levels Stability

Completed NA Last updated 9 February 2024
What this trial tests

NA trial testing Implant placement in Dental Implant in 18 participants. Completed in 20 October 2023.

Timeline
10 January 2020
Primary endpoint
15 May 2021
20 October 2023

Quick facts

Lead sponsorASST Santi Paolo e Carlo
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment18
Start date10 January 2020
Primary completion15 May 2021
Estimated completion20 October 2023
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

ASST Santi Paolo e Carlo

Who can join

Adults 18 to 70, any sex, with Dental Implant or Marginal Bone Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the present prospective study was to investigate after a 2-year of follow-up any influence of the surgical technique, manual or digitally guided, on peri-implant marginal bone levels stability in implants placed 1 mm sub-crestally. Patients were treated by means of platform-switched implants provided with a 5 degrees internal conical connection and supporting single screw-retained fixed crowns. Marginal bone level (MBL) measured at prosthesis installation (t0) at 1 (t1), 2 (t2) and at 3 years of follow-up visit (t3) were considered. MBL change from t0 to t3 was investigated. The distance between the implant neck and the first radiographically detected bone to implant contact was considered to evaluate the bone loss. Two groups were considered: Test Group (GD) for implant sites treated with a digitally guided surgery procedure. Control Group (FH) for implants surgically placed without digitally guided surgery, respectively. All the procedures were performed by an experienced operator. Additionally, for both groups MBL changes were correlated to different supra-crestal soft tissue height (STH) amounts: less than 3 and ≥ 3 millimeters, respectively. Peri-implant soft tissue parameters such as probing depth (PPD), modified Sulcus Bleeding Index (mBI) and modified Plaque Index (mPI), were assessed for all the restorations included.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Implant placement

Trials testing the same drug.

Other recruiting trials for Dental Implant

Currently open trials in the same condition.

Other ASST Santi Paolo e Carlo trials

Trials by the same sponsor.

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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/NCT06250621.

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