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Immediate Functional Versus Non Functional Implant Loading in the Mandible

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04521530
Recruitment Status : Completed
First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Hams Hamed Abdelrahman, Alexandria University

Study Description
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Brief Summary:
comparing immediate functionally loaded implants and immediate non functionally loaded implants in the posterior mandibular region on bases of bone density and bone loss evaluated by cone-beam computed tomography (CBCT).

Condition or disease Intervention/treatment Phase
Dental Implants Edentulous Alveolar Ridge Other: immediate functional implant loading Other: immediate non functional implant loading Not Applicable

Detailed Description:

Patients are more demanding after the revolution in immediate implant dentistry which reduces implant procedure nowadays according to literature and research. In response to patients' demands not only implants are immediately placed but also immediately loaded within 72 hours reducing the time for prosthetic loading and also improving bone formation according to some studies. The debate in modern implant dentistry is whether to immediately load the implants in functional occlusion or non-functional occlusion and which will improve the osseointegration and reduce crestal bone loss.

Implants of the BioInfinity system were placed in 16 subjects divided into two groups.

Group (A): 8 patients with missing posterior mandibular teeth whom will be rehabilitated with immediate functionally loaded implants.

Group (B): 8 patients with missing posterior mandibular teeth in whom immediate non-functionally loaded implants were used.

The two groups were evaluated at baseline, immediately after implant placement and 4 months postoperative to evaluate crestal bone level and quantitative radiographic bone density using CBCT.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study Between Immediate Functional and Non-functional Loading of Dental Implants in the Posterior Alveolar Mandibular Region (a Randomized Clinical Trial)
Actual Study Start Date : December 1, 2019
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 29, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: immediate functional loading with temporary crowns
patients were rehabilitated with immediate functionally loaded implants.
 Other: immediate functional implant loading
Patients will undergo implant placement and a minimum of 35 Ncm reading with the graded torque wrench. Temporary crowns in functional occlusion were cemented.
Experimental: immediate non functional loading with temporary crowns
patients were rehabilitated with immediate non-functionally loaded implants.
 Other: immediate non functional implant loading
implant will be placed into the site following the manufacturer's protocol making sure to have a minimum of 35 Newton centimeter reading with the degraded torque wrench. Non-functional temporary crowns were cemented.


Outcome Measures
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Primary Outcome Measures :
  1. Pain score [ Time Frame: immediately Postoperatively ]
    Visual analogue scale consist of a scale of 10 0 means no pain 10 menas pain is as bad as it could possibly be

  2. Change in crestal bone loss [ Time Frame: immediately Postoperatively and after 4 months ]
    CBCT was done immediately after implant placement and 4 months postoperatively to assess crestal bone loss


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients aged (20-40) years old.
  • Missing Posterior tooth or teeth indicated for implant placement.
  • Residual alveolar ridge at least 10 mm high and at least 4 mm wide.

Exclusion Criteria:

  • Systemic diseases that will contraindicate the surgery.
  • Poor Oral Hygiene.
  • The patient refuses to undergo the surgery.
  • Parafunctional habits.
Contacts and Locations
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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): NCT04521530


Locations
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Egypt
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
Sponsors and Collaborators
Hams Hamed Abdelrahman
More Information
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Responsible Party: Hams Hamed Abdelrahman, Assistant lecturer, Alexandria University
ClinicalTrials.gov Identifier: NCT04521530    
Other Study ID Numbers: Dental implants
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases