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NCT06178536

Clinical and Radiographic Assessment of a Novel Wedge Shape Implant Placed in Edentulous Narrow Ridges

Completed NA Last updated 21 December 2023
What this trial tests

NA trial testing Bone Consumption in Surgical Technique in 18 participants. Completed in 1 December 2023.

Timeline
3 June 2021
Primary endpoint
1 December 2023
1 December 2023

Quick facts

Lead sponsorChristian Makary
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment18
Start date3 June 2021
Primary completion1 December 2023
Estimated completion1 December 2023
Sites1 location across Lebanon

Drugs / interventions tested

Conditions studied

Sponsor

Christian Makary

Who can join

Adults 35 to 62, any sex, with Surgical Technique or Implant Surface. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim is to clinically and radiographically assess a novel wedge implant placed in narrow ridges. * 60 wedge implants (Rex Implants, Columbus, OH, USA) will be placed using Piezosurgery® following either a bone consumption (n=30) or bone expansion technique (n=30). Each group (bone consumption and bone expansion) will be divided into 2 surface treatments: machined transcortical portion (n=15) and roughened transcortical portion (n=15). * Record the time needed to place each implant. * ISQ will be evaluated at Day 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement. * Periapical radiographs will be performed at implant placement, loading. and 1, 3, and 5 years after loading to assess marginal bone stability. * Buccal bone height and lingual and buccal bone thickness will be recorded post-intervention, at the time of functional loading, and at 12, 36, and 60 months after loading with CBCT. * Digital impressions will be taken post-operatively, at loading and at 12 months after loading to monitor gingival profile.

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