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Trial · NCT07893873

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Facial Hard Tissue Thickness at 2 mm Apical to the Implant ShoulderPostoperative baseline and 5 years after GBR, with an allowable follow-up window of plus or minus 12 months (T5).
Facial hard tissue thickness will be measured in millimeters using clinically obtained cone-beam computed tomography (CBCT) images at 2 mm apical to the implant shoulder. The primary outcome is the change in thickness from the postoperative baseline to the long-term follow-up assessment (T5). No CBCT examination will be performed solely for research purposes.
SecondaryAugmented Hard Tissue Volume at Long-Term Follow-Up and Change From Postoperative BaselinePostoperative baseline and 5 years after GBR, with an allowable follow-up window of plus or minus 12 months (T5).
Augmented hard tissue volume will be measured in cubic millimeters using clinically obtained CBCT datasets. The outcomes are the augmented hard tissue volume at the long-term follow-up assessment (T5) and its change from the postoperative baseline. No CBCT examination will be performed solely for research purposes.
SecondaryFacial Hard Tissue Thickness at the Implant Shoulder and 4 mm Apical to the Implant Shoulder at Long-Term Follow-UpAt 5 years after GBR, with an allowable window of plus or minus 12 months (T5).
Facial hard tissue thickness will be measured in millimeters using clinically obtained CBCT images at the implant shoulder level (0 mm) and at 4 mm apical to the implant shoulder. Thickness at the long-term follow-up assessment (T5) will be evaluated separately at each measurement level. No CBCT examination will be performed solely for research purposes.
SecondaryMarginal Bone Level at Long-Term Follow-UpAt 5 years after GBR, with an allowable window of plus or minus 12 months (T5).
Marginal bone level will be assessed in millimeters using clinically obtained CBCT images at the long-term follow-up assessment (T5). No CBCT examination will be performed solely for research purposes.
SecondaryFacial Soft Tissue Thickness at Long-Term Follow-UpAt 5 years after GBR, with an allowable window of plus or minus 12 months (T5).
Facial soft tissue thickness will be assessed in millimeters at the implant shoulder level and 2 mm apical to the implant shoulder by registering T5 intraoral scan data with clinically obtained CBCT data. Values at the two measurement levels will be reported separately. No CBCT examination will be performed solely for research purposes.
SecondaryFacial Soft Tissue Height at Long-Term Follow-UpAt 5 years after GBR, with an allowable window of plus or minus 12 months (T5).
Facial soft tissue height will be assessed in millimeters by registering intraoral scan data collected at the long-term follow-up assessment (T5) with clinically obtained CBCT data. No CBCT examination will be performed solely for research purposes.
SecondaryImplant Survival at Long-Term Follow-UpFrom implant placement to the long-term assessment at 5 years after GBR, with an allowable window of plus or minus 12 months (T5).
Implant survival status will be assessed using existing clinical records and the long-term follow-up assessment (T5). Whether each implant remains in place or has been lost or removed will be recorded, together with the date of loss or removal when available.
SecondaryImplant-Supported Restoration Survival at Long-Term Follow-UpFrom definitive restoration placement to the long-term assessment at 5 years after GBR, with an allowable window of plus or minus 12 months (T5).
The survival status of the implant-supported restoration will be assessed using existing restorative and follow-up records and the long-term clinical assessment (T5). Whether the original definitive restoration remains in place will be recorded. Documented loss or replacement of the restoration, including the date and reason when available, will also be recorded.
SecondaryBiological Complications at Long-Term Follow-UpFrom GBR to the long-term assessment at 5 years after GBR, with an allowable window of plus or minus 12 months (T5).
Biological complications at the implant and guided bone regeneration sites will be assessed using existing clinical and follow-up records and the long-term clinical examination (T5). The presence and type of documented complications will be recorded, together with their timing and management when available.
SecondaryMechanical Complications at Long-Term Follow-UpFrom implant placement to the long-term assessment at 5 years after GBR, with an allowable window of plus or minus 12 months (T5).
Mechanical complications involving the implant-supported restoration and implant components will be assessed using existing clinical, restorative, and follow-up records and the long-term clinical examination (T5). The presence and type of documented complications will be recorded, together with their timing and management when available.
SecondaryPeri-Implant Probing Depth at Long-Term Follow-UpAt 5 years after GBR, with an allowable window of plus or minus 12 months (T5).
Peri-implant probing depth will be measured in millimeters during the periodontal examination at the long-term follow-up assessment (T5). Probing depth measurements at the examined sites around each implant will be recorded.
SecondaryPeri-Implant Bleeding on Probing at Long-Term Follow-UpAt 5 years after GBR, with an allowable window of plus or minus 12 months (T5).
Bleeding on probing will be assessed during the peri-implant examination at the long-term follow-up assessment (T5). The presence or absence of bleeding following probing will be recorded at each examined site around the implant.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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