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Table 1 Study design and time schedule for the intervention

From: Cell therapy induced regeneration of severely atrophied mandibular bone in a clinical trial

Intervention

Day –21 (pre inclusion visit or earlier)

Day 0 (inclusion visit)

Days 12–14

Month 1

Month 6

Month 9

Month 18

Verification of the selection criteria, information given to the patient, patient records and informed consent obtained

X

      

Panoramic X-ray scans

X

   

X

X

X

Loco-regional clinical examination

X

X

X

X

X

X

X

Impression of both dental arches

X

    

X

 

Facial and oral cavity photographs

X

     

X

Dental radiographs

X

   

X

X

X

VAS score for pain

  

X

X

X

X

X

Questionnaire on use of painkillers

  

X

X

X

X

X

Bone marrow harvest

X

      

Grafting procedure

 

X

     

CBCT scan

X

 

X

 

X

 

X

Implant placement, bone biopsy

    

X

  

Resonance frequency Analysis (ISQ RFA)

    

X

X

X

Implant loading (prosthesis)

     

X

 

Adverse events, clinical examination

 

X

X

X

X

X

X

  1. VAS visual analog scale, CBCT cone beam computer tomography, ISQ implant stability quotient, RFA resonance frequency analysis