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Immediate Implants Inserted Through Open Flap, Open Flap and Bone Grafting and Flapless Techniques (ETPEI-RCT)

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ClinicalTrials.gov Identifier: NCT03001752
Recruitment Status : Not yet recruiting
First Posted : December 23, 2016
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
Felice Roberto Grassi, University of Bari

Brief Summary:
This is a three-armed randomized controlled clinical trial aiming the estimation of dimensional alveolar bone changes after insertion of post-extraction implants through 3 different surgical techniques: open flap, open flap and grafting, flapless.

Condition or disease Intervention/treatment Phase
Isolated Premolar Edentulous Site Device: Open flap immediate implant Device: Open flap immediate implant and bone grafting Device: Flapless immediate implant Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Morphological and Dimensional Alveolar Bone Changes Around Post-extraction Implants in an Open Flap, Open Flap and Grafting and Flapless Technique. A Clinical Randomized Controlled Study
Study Start Date : January 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Active Comparator: Open flap immediate implant
Open flap immediate implant insertion, without bone grafting
Device: Open flap immediate implant
Post-extraction implants will be inserted through open flap, without bone grafting
Other Name: Dental implant

Active Comparator: Open flap immediate implant and bone grafting
Open flap immediate implant insertion and bone grafting
Device: Open flap immediate implant and bone grafting
Post-extraction implants will be inserted through open flap, adding bone grafting
Other Name: Dental implant, bone grafting

Active Comparator: Flapless immediate implant
Immediate implant insertion without opening flap of inserting bone grafting
Device: Flapless immediate implant
Post-extraction implants will be inserted without elevating flap or inserting bone grafting




Primary Outcome Measures :
  1. Marginal Bone Loss measured through CT Cone Beam [ Time Frame: 6 months ]
    Difference of marginal bone level measured immediately after treatment and 6 months after on two repeated (immediately after and 6 months after implant insertion) CT Cone Beam

  2. Alveolar Bone Dimensional Reduction assessed through CT Cone Beam [ Time Frame: 6 months ]
    Three-dimensional Alveolar Bone Reduction (horizontal and vertical) will be measured on two repeated (immediately after and 6 months after implant insertion) on CT Cone Beam, having as reference points the implant platform and the implant apex.


Secondary Outcome Measures :
  1. Pain and Discomfort measured through questionaire [ Time Frame: 1 Week ]
    Pain and discomfort experienced by the patient after the surgery, measured through a VAS scale on a questionaire

  2. Intra-operatory or post-operatory complications assessed through intra-operatory observation and post-intervention check-ups. [ Time Frame: 6 months ]
    Intra-operatory or post-operatory intervention-related adverse events such as excessive bleeding, swallowing, hematoma will be recorded for each patient.

  3. Time needed to perform surgical intervention [ Time Frame: 1-2 hours ]
    Time needed to perform surgical intervention (immediately after tooth extraction until finishing of surgical procedure) will be recorded for each intervention.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • absence of any systemic disease that might compromise implant integration or wound healing
  • appropriate periodontal health (measured through periodontal indexes)
  • presence of premolars with indications of extractions, presence of adjacent teeth
  • absence of fenestrations
  • presence of vestibular alveolar wall with a minimum of 0.5mm of thickness

Exclusion Criteria:

  • patients who have undergone CT scanning in the past 5 years
  • heavy smokers (more than 20 cigarettes per day)
  • patients not showing up at 1 and 3 months hygiene sessions
  • patients not showing up at 6 months follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001752


Contacts
Contact: Felice Roberto Grassi, Professor 0039355441230 feliceroberto.grassi@uniba.it
Contact: Zamira Kalemaj, DDS, PhD 00393426478231 kalemajzamira@gmail.com

Sponsors and Collaborators
University of Bari